[Federal Register: April 21, 2010 (Volume 75, Number 76)]
[Notices]
[Page 20837-20838]
[DOCID:fr21ap10-56]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2009-0532; FRL-9140-6; EPA ICR Number 1678.07, OMB Control
Number 2060-0326]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Magnetic Tape
Manufacturing Operations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

DATES: Additional comments may be submitted on or before May 21, 2010.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2009-0532, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
28221T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2)
OMB at: Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th
Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Robert C. Marshall, Jr., Office of
Compliance, Mail Code: 2223A, Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202)
564-7021; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On July 30, 2009 (74 FR 38004), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2009-0532, which is available for public viewing
online at http://www.regulations.gov, in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search'', then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov, as EPA
receives them and without change, unless the comment contains
copyrighted material, confidential business information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: NESHAP for Magnetic Tape Manufacturing Operations (Renewal).
    ICR Numbers: EPA ICR Number 1678.07, OMB Control Number 2060-0326.
    ICR Status: This ICR is scheduled to expire on June 30, 2010. Under
OMB regulations, the Agency may continue to conduct or sponsor the
collection of information while this submission is pending at OMB. An
Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, and displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control

numbers in certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 63, subpart A, and any changes,
or additions to the Provisions specified at 40 CFR part 63, subpart EE.
Owners or operators of the affected facilities must submit a one-time-
only report of any physical or operational changes, initial performance
tests, and periodic reports and results. Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. Reports, at a minimum, are required semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 200
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Magnetic tape manufacturing
operations.
    Estimated Number of Respondents: 6.
    Frequency of Response: Initially, occasionally, quarterly,
semiannually and annually.
    Estimated Total Annual Hour Burden: 3,396.
    Estimated Total Annual Cost: $366,607, which includes $319,607 in
labor costs, $11,000 in capital/startup costs, and $36,000 in operation
and maintenance (O&M) costs.
    Changes in the Estimates: There is no change in the estimation
methodology of labor hours in this ICR compared to the previous ICR.
This is due to two considerations: (1) The regulations have not changed
over the past three years and are not anticipated to change over the
next three years; and (2) the growth rate for the industry is very low,
negative or non-existent. Therefore, the labor hours in the previous
ICR reflect the current burden to the respondents and are reiterated in
this ICR. Because this ICR carries two decimal places in calculations
within Table 1, there is an apparent increase of one labor hour in this
ICR compared to the previous ICR which presented calculation results
rounded to a whole number.
    The increase in cost to respondents and the Agency is due to labor
rate adjustments to reflect rates for fiscal year 2009. This increase
is not due to any program changes. Labor rates reflected in the
previous ICR were based on fiscal year 2003.

    Dated: April 15, 2010.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2010-9171 Filed 4-20-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 231 (Monday, December 2, 2019)]
[Notices]
[Pages 65983-65985]
[FR Doc No: 2019-25986]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3124]

Adaptive Designs for Clinical Trials of Drugs and Biologics;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Adaptive
Designs for Clinical Trials of Drugs and Biologics.'' This guidance
provides guidance to sponsors and applicants submitting investigational
new drug applications (INDs), new drug applications (NDAs), biologics
license applications (BLAs), or supplemental applications on the
appropriate use of adaptive designs for clinical trials to provide
evidence of the effectiveness and safety of a drug or biological
product. The guidance describes important principles for designing,
conducting, and reporting the results from an adaptive clinical trial.
This guidance finalizes the draft guidance entitled ``Adaptive Designs
for Clinical Trials of Drugs and Biologics'' issued in October 2018.
    FDA is also announcing that a proposed collection of information
has been submitted to the Office of Management and Budget (OMB) for
review and clearance under the Paperwork Reduction Act of 1995.

DATES: The announcement of the guidance is published in the Federal
Register on December 2, 2019. Submit either electronic or written
comments on the collection of information by January 2, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, please note that late, untimely filed comments will not be
considered. Electronic comments must be submitted on or before January
2, 2020. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of January 2,
2020. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is on or before that date. OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax:<PHONE_NUMBER>,
or emailed to<EMAIL_ADDRESS>All comments should be
identified with the title ``Adaptive Designs for Clinical Trials of
Drugs and Biologics'' and the OMB control number 0910-0014. Also
include the FDA docket number found in brackets in the heading of this
document.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-3124 for ``Adaptive Designs for Clinical Trials of Drugs and
Biologics.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Scott Goldie,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 21, Rm. 3557, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>; or Stephen Ripley, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the information collection: Domini Bean, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Adaptive Designs for Clinical Trials of Drugs and
Biologics.'' The guidance provides recommendations to sponsors and
applicants submitting INDs, NDAs, BLAs, or supplemental applications on
the appropriate use of adaptive designs for clinical trials to provide
evidence of the effectiveness and safety of a drug or biologic. Agency
regulations in 21 CFR parts 312, 314, and 601 govern the format and
content of information that must be included in IND, NDA, and BLA
submissions, respectively, and set forth general requirements regarding
supporting documentation and recordkeeping associated with the various
applicable provisions.
    Recommendations found in the guidance describe principles we
consider important for designing, conducting, and reporting the results
from an adaptive clinical trial. The guidance also discusses the types
of information FDA will evaluate from clinical trials with adaptive
designs, including Bayesian adaptive and complex trials that rely on
computer simulations for their design. The primary focus of this
guidance is on adaptive designs for clinical trials intended to support
the effectiveness and safety of drugs and biological products.
    This guidance finalizes the draft guidance of the same title issued
on October 1, 2018 (83 FR 49400). FDA considered comments received on
the draft guidance as the guidance was finalized. Changes from the
draft to the final guidance include: (1) Reworking the subsection on
Bayesian adaptive designs to clarify the Agency's recommendations and
(2) clarifying the extent of prespecification required for the rules
governing adaptations. In addition, editorial changes were made to
improve clarity.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Adaptive Designs for Clinical Trials of
Drugs and Biologics.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    In compliance with 44 U.S.C. 3507, FDA has submitted the following
proposed collection of information to OMB for review and clearance.

Investigational New Drug Regulations OMB Control Number 0910-0014--
Revision

    In accordance with 21 CFR 312.145, we are making this guidance
available under our good guidance practices regulations in 21 CFR
10.115 to help respondents comply with regulatory requirements
associated with submitting INDs, NDAs (currently approved under OMB
control number 0910-0001), and BLAs (currently approved under OMB
control number 0910-0338). In section VIII.B., the guidance states that
the documented plan for a clinical trial with a proposed adaptive
design should include certain information. The information could be
included in the clinical trial protocol and/or in separate documents,
such as: (1) A statistical analysis plan, (2) a data monitoring
committee (DMC) charter, or (3) an adaptation committee charter.
Although different types of information might be included in different
documents, all important information described below should be
submitted to FDA during the design stage so that FDA has sufficient
time to provide feedback prior to initiation of the clinical trial:
     A rationale for the selected design;
     A detailed description of the monitoring and adaptation
plan, including the anticipated number and timing of interim analyses,
the specific aspects of the design that may be modified, and the rule
that will be used to make adaptation decisions;
     Information on the roles of the bodies responsible for
implementing the adaptive design, such as the DMC and/or the dedicated
adaptation committee, if applicable;
     Prespecification of the statistical methods that will be
used to produce interim results, guide adaptation decisions, carry out
hypothesis tests, estimate treatment effects, and estimate uncertainty
in treatment effect estimates at the end of the trial;
     Evaluation and discussion of the design operating
characteristics; and
     In cases where simulations are the primary or sole
technique for evaluating trial operating characteristics, a detailed
simulation report should be submitted, including:
    [cir] An overall description of the trial design;
    [cir] Example trials, in which a small number of hypothetical
trials are described with different conclusions, such as a positive
trial with the original sample size, a trial stopped for futility after
the first interim look, a positive trial after increasing the sample
size, etc.;
    [cir] A description of the set of parameter configurations used for
the simulation scenarios, including a justification of the adequacy of
the choices;
    o The number of simulated trials (iterations) evaluated for each
scenario and a rationale for the adequacy of this number;
    [cir] Simulation results detailing the estimated operating
characteristics under the various scenarios;
    [cir] Simulation code that is readable and adequately commented and
should include the random seeds used to generate the simulation
results; and
    [cir] A summary providing overall conclusions.
     A comprehensive written data access plan defining how
trial integrity will be maintained in the presence of the planned
adaptations. This documentation should include information regarding:
(1) The personnel who will perform the interim analyses, (2) the
personnel who will have access to interim results, (3) how that access
will be controlled, (4) how adaptive decisions will be made, and (5)
what type of information will be disseminated following adaptive
decisions, and to whom it will be disseminated. The data access plan
should describe what information (and under what circumstances) is
permitted to be passed to the sponsor or investigators. In addition, it
is recommended that sponsors establish procedures to evaluate
compliance with the data access plan and to document all interim
meetings of the committee tasked with making adaptation decisions
(i.e., the DMC or other adaptation committee). For example, interim
meetings should be documented with written meeting minutes describing
what was reviewed, discussed, and decided.

    In section VIII.C., the guidance states that a marketing
application to FDA that relies on a trial with an adaptive design
should include sufficient information and documentation to allow FDA to
thoroughly review the results, including:
     All prospective plans, any relevant committee charters
(e.g., the DMC or adaptation committee charter), and any supporting
documentation (e.g., literature references, programming code,
simulation report);
     Information on compliance with the planned adaptation rule
and with the procedures outlined in the data access plan to maintain
trial integrity;
     Records of deliberations and participants for any interim
discussions by any committees involved in the adaptive process;
     Results of the interim analyses or analyses used for the
adaptation decisions; and
     Appropriate reporting of the adaptive design and trial
results in section 14 of the proposed package insert. For example, the
trial summary should describe the adaptive design utilized. In
addition, treatment effect estimates should adequately take the design
into account, or if na[iuml]ve estimates such as unadjusted sample
means are used, the extent of bias should be evaluated, and estimates
should be presented with appropriate cautions regarding their
interpretation.
    Discussion of the plans for an adaptive trial can be the basis for
requesting a Type C meeting. Regulatory mechanisms for obtaining
formal, substantive feedback from FDA on clinical trials may also
include end-of-phase-2 meetings. The guidance also recommends that
special protocol assessments (given the 45-day response timeline) be
submitted for trials with complex adaptive designs only if there has
been extensive previous discussion between FDA and the sponsor
regarding the proposed trial and design. The guidance explains that in
their submissions, sponsors should prespecify the details of the
adaptive design and provide justification that the chances of erroneous
conclusions will be adequately controlled, estimation of treatment
effects will be sufficiently reliable, and trial integrity will be
appropriately maintained. The guidance notes that the sponsor should
advise FDA during the course of a trial of any proposed changes to the
trial design (usually through protocol amendments) and that FDA may
request that the sponsor submit minutes from open sessions of a
monitoring committee during an ongoing trial.
    As noted above, in the Federal Register of October 1, 2018, FDA
published a 60-day notice requesting public comment on the proposed
collection of information.
    There were 21 distinct commenters during this time frame, including
from industry, drug associations, individuals, and academia, with
multiple comments from each distinct commenter.
    The majority of comments on the guidance related to format,
clarity, or word choice, providing specific technical recommendations
on statistical methodologies. Because we do not believe these
considerations have any effect on the information collection burden, we
have made no changes to our estimate.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
    Guidance for industry on                         Number of
  adaptive designs for clinical      Number of     responses per   Total annual      Hours per      Total hours
  trials of drugs and biologics     respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Clinical trial protocols and                  40               6             240              50          12,000
 related submissions to FDA with
 an adaptive design and analysis
 plan should contain the
 information in section VIII.B..
Marketing applications that rely              15            1.33              20              50           1,000
 on studies with an adaptive
 design should contain the
 information in section VIII.C..
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          13,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on our review of INDs, NDAs, BLAs, and supplemental
applications for the use of adaptive designs for clinical trials to
provide evidence of effectiveness and safety, we estimate that
approximately 40 sponsors or applicants will prepare approximately 240
documented plans for clinical trials containing a proposed adaptive
design and analysis plan and will submit this information to FDA in a
clinical trial protocol and/or in separate documents such as a
statistical analysis plan, a data monitoring committee charter, or an
adaptation committee charter. In addition, we estimate that preparing
and submitting this information will take approximately 50 hours per
sponsor or applicant.
    Furthermore, we estimate that approximately 15 sponsors or
applicants will prepare and submit to FDA approximately 20 marketing
applications that rely on a trial with an adaptive design and that
preparing and submitting this information will take approximately 50
hours per sponsor or applicant.
    FDA is issuing this final guidance subject to OMB approval of the
collections of information. Before implementing the information
collection provisions of the guidance, FDA will publish a notice in the
Federal Register announcing OMB's decision to approve, modify, or
disapprove the collections of information, including OMB control
number(s) for newly approved collections.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25986 Filed 11-29-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 135 (Thursday, July 14, 2016)]
[Notices]
[Pages 45517-45518]
[FR Doc No: 2016-16628]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2016-0017; OMB No. 1660-0022]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Community Rating System (CRS) Program--Application
Worksheets and Commentary

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on an extension, without change, of a currently approved
information collection. In accordance with the Paperwork Reduction Act
of 1995, this notice seeks comments concerning application for the
National Flood Insurance Program's Community Rating System program.
This program allows communities to become eligible for discounts on the
cost of flood insurance when the communities undertake activities to
mitigate anticipated damage due to flooding. The application materials
verify and document the community mitigation activities performed and
provides the Federal Emergency Management Agency with the information
necessary to determine what flood insurance premium discounts are
appropriate for participating communities.

DATES: Comments must be submitted on or before September 12, 2016.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2016-0017. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW., 8NE., Washington, DC 20472-
3100.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
Rulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it

public. You may wish to read the Privacy Act notice that is available
via the link in the footer of www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Bill Lesser, Program Specialist,
Federal Insurance and Mitigation Administration,<PHONE_NUMBER>. You
may contact the Records Management Division for copies of the proposed
collection of information at email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Section 541 of the National Flood Insurance
Reform Act (NFIRA) of 1994, 42 U.S.C. 4022, requires that a community
rating system be established. This ratings system is a voluntary
program for communities and it would provide a method by which flood
mitigation activities engaged in by these communities could be
measured. The effect of this mitigation activity would reduce the
exposure of the communities to damages resulting from flooding and in
turn reduce the losses incurred as a result of this flooding. To
encourage participation, discounts on flood insurance are offered
within communities that successfully complete qualified mitigation
actions, and the community ratings system provides the ability to
measure these actions and to recertify the communities in successive
years.

Collection of Information

    Title: Community Rating System (CRS) Program--Application
Worksheets and Commentary.
    Type of Information Collection: Extension, without change, of a
currently approved information collection.
    OMB Number: 1660-0022.
    FEMA Forms: FEMA Form 086-0-35, Community Rating System Application
Letter of Interest and Quick Check Instructions; FEMA Form 086-0-35A,
Community Annual Recertification; and FEMA Form 086-0-35B,
Environmental and Historic Preservation Certifications.
    Abstract: The Application and Certifications are used by
communities that participate in the National Flood Insurance Program's
(NFIP) Community Rating System (CRS). The CRS is a voluntary program
where flood insurance costs are reduced in communities that implement
practices, such as building codes and public awareness activities,
which are considered to reduce the risks of flooding and promote the
purchase of flood insurance.
    Affected Public: State, Local or Tribal government.
    Number of Respondents: 1,579.
    Number of Responses: 1,579.
    Estimated Total Annual Burden Hours: 41,936 hours.
    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $2,442,795.30. There are no annual costs to respondents'
operations and maintenance costs for technical services. There are no
annual start-up or capital costs. The cost to the Federal Government is
$5,425,600.00.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: July 6, 2016.
Richard W. Mattison,
Records Management Program Chief, Mission Support, Federal Emergency
Management Agency, Department of Homeland Security.
[FR Doc. 2016-16628 Filed 7-13-16; 8:45 am]
 BILLING CODE 9111-52-P


[Federal Register: August 28, 2007 (Volume 72, Number 166)]
[Rules and Regulations]
[Page 49183-49186]
[DOCID:fr28au07-19]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-27687; Directorate Identifier 2000-NE-42-AD;
Amendment 39-15179; AD 2007-07-07R1]
RIN 2120-AA64

Airworthiness Directives; General Electric Company CF34-1A, -3A,
-3A1, -3A2, -3B, and -3B1 Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is revising an existing airworthiness directive (AD)
for General Electric Company (GE) CF34-1A, -3A, -3A1, -3A2, -3B, and -
3B1 turbofan engines. That AD currently requires a one-time inspection
of certain fan disks for electrical arc-out indications, replacing fan
disks with electrical arc-out indications, and reducing the life limit
of certain fan disks. This AD results from a comment received on AD
2007-07-07, and from recently issued revisions to the applicable GE
Alert Service Bulletins (ASBs). We are issuing this AD to prevent an
uncontained fan disk failure and airplane damage.

DATES: Effective September 12, 2007. The Director of the Federal
Register approved the incorporation by reference of certain
publications listed in the regulations as of September 12, 2007.
    We must receive any comments on this AD by October 29, 2007.

ADDRESSES: Use one of the following addresses to comment on this
proposed AD.
     DOT Docket Web site: Go to http://dms.dot.gov and follow

the instructions for sending your comments electronically.
     Government-wide rulemaking Web site: Go to http://www.regulations.gov
 and follow the instructions for sending your

comments electronically.
     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.
     Fax:<PHONE_NUMBER>.
    You can get the service information identified in this AD from
General Electric Company via Lockheed Martin Technology Services, 10525
Chester Road, Suite C, Cincinnati, Ohio 45215; telephone (513) 672-
8400; fax<PHONE_NUMBER>.
    The Docket Operations office is located at U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Tara Chaidez, Aerospace Engineer,
Engine Certification Office, FAA, Engine and Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On March 30, 2007, the FAA issued AD 2007-
07-07, Amendment 39-15012 (72 FR 16998, April 6, 2007). That AD
requires a onetime inspection of certain fan disks for electrical arc-
out indications, replacing fan disks with electrical arc-out
indications, and reducing the life limit of certain fan disks. That AD
was the result of a report that in January 2007, a CF34-3B1 turbofan
engine experienced an uncontained fan disk failure during flight
operation. That condition, if not corrected, could result in an
uncontained fan disk failure and airplane damage.

Actions Since AD 2007-07-07 Was Issued

    Since AD 2007-07-07 was issued, we received a comment from Star Air
A/S, requesting clarification of the compliance requirement in Table C,
item (ii). We published Table C as follows:

 Table C.--Business Jet Shop-Level Fan Disk Inspection Compliance Times
------------------------------------------------------------------------
             For fan disks                           Inspect
------------------------------------------------------------------------
(i) That have more than 5,500 flight     Within 500 flight hours after
 hours on the effective date of this AD.  the effective date of this AD.
(ii) That have 5,500 or fewer flight     Within accumulating a total of
 hours on the effective date of this AD.  6,000 fan disk operating hours-
                                          since-new, or 5 calendar
                                          years, whichever occurs first.
------------------------------------------------------------------------

    The commenter asks if we intended to state ``within 5 calendar
years after the effective date of the AD'', or, ``within 5 years-since-
new.'' We intended to state ``within 5 years after the effective date
of the AD.'' For clarification, we revised Table C as follows:

 Table C.--Business Jet Shop-Level Fan Disk Inspection Compliance Times
------------------------------------------------------------------------
             For fan disks                           Inspect
------------------------------------------------------------------------
(i) That have not had a shop-level       Within 500 flight hours after
 inspection and have more than 5,500      the effective date of this AD.
 flight hours on the effective date of
 this AD.
(ii) That have not had a shop-level      Within accumulating a total of
 inspection and have 5,500 or fewer       6,000 fan disk operating hours-
 flight hours on the effective date of    since-new.
 this AD.

(iii) That have had a shop-level         Within accumulating an
 inspection and have 5,500 or fewer       additional 6,000 fan disk
 flight hours on the effective date of    operating hours-since-shop-
 this AD.                                 level inspection, or within 5
                                          calendar years from the
                                          effective date of this AD,
                                          whichever occurs first.
------------------------------------------------------------------------

    Also, since that AD was issued, GE issued revisions to the
applicable ASBs to make document reference updates and accomplishment
instruction updates. We reference these ASB revisions in this AD
revision.

Relevant Service Information

    We have reviewed and approved the technical contents of GE ASB No.
CF34-BJ S/B 72-A0212, Revision 3, dated June 27, 2007, ASB No. CF34-AL
S/B 72-A0233, Revision 3, dated June 27, 2007, and ASB No. CF34-AL S/B
72-A0231, Revision 1, dated June 27, 2007. All three ASBs list the
affected fan disks by serial number and part number. The first two ASBs
describe procedures for performing fluorescent penetrant inspection
(FPI), a Tactile and Enhanced Visual (TEV) inspection, and eddy current
inspection (ECI) for cracks and electrical arc-out defects. The third
ASB describes procedures for performing an on-wing TEV inspection of
fan disks for electrical arc-out defects.

FAA's Determination and Requirements of This AD

    The unsafe condition described previously is likely to exist or
develop on other GE CF34-1A, -3A, -3A1, -3A2, -3B, and -3B1 turbofan
engines of the same type design. We are issuing this AD to prevent an
uncontained fan disk failure and airplane damage. This AD requires on-
wing TEV inspection of fan disks for electrical arc-out defects on fan
disks installed on regional jets within 500 flight hours after the
effective date of this AD. This AD also requires for all affected fan
disks shop-level FPI, enhanced TEV, and ECI inspections for cracks and
electrical arc-out defects. This AD also carries forward from AD 2006-
05-04 the reduced life limit for certain fan disks. You must use the
service information described previously to perform the actions
required by this AD.

FAA's Determination of the Effective Date

    Since an unsafe condition exists that requires the immediate
adoption of this AD, we have found that notice and opportunity for
public comment before issuing this AD are impracticable, and that good
cause exists for making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment; however, we invite you to send us any written relevant data,
views, or arguments regarding this AD. Send your comments to an address
listed under ADDRESSES. Include ``AD Docket No. FAA-2007-27687;
Directorate Identifier 2000-NE-42-AD'' in the subject line of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify it.
    We will post all comments we receive, without change, to http://dms.dot.gov
, including any personal information you provide. We will

also post a report summarizing each substantive verbal contact with FAA
personnel concerning this AD. Using the search function of the DMS Web
site, anyone can find and read the comments in any of our dockets,
including the name of the individual who sent the comment (or signed
the comment on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477-78) or you may visit
http://dms.dot.gov.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://dms.dot.gov
; or in person at the Docket Operations office between 9

a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is provided in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

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.
    We are 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

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will 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 that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a summary of the costs to comply with this AD and
placed it in the AD Docket. You may get a copy of this summary at the
address listed under ADDRESSES.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Under the authority delegated to me by the Administrator, the
Federal Aviation Administration amends part 39 of the Federal Aviation
Regulations (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 removing Amendment 39-15012 (72 FR
16998, April 6, 2007), and by adding a new airworthiness directive,
Amendment 39-15179, to read as follows:

2007-07-07R1 General Electric Company: Amendment 39-15179. Docket
No. FAA-2007-27687; Directorate Identifier 2000-NE-42-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective
September 12, 2007.

Affected ADs

    (b) This AD revises AD 2007-07-07.

Applicability

    (c) This AD applies to General Electric Company (GE) CF34-1A, -
3A, -3A1, -3A2, -3B, and -3B1 turbofan engines, with fan disks part
numbers (P/Ns) 5921T18G01, 5921T18G09, 5921T18G10, 5921T54G01,
5922T01G02, 5922T01G04, 5922T01G05, 6020T62G04, 6020T62G05,
6078T00G01, 6078T57G01, 6078T57G02, 6078T57G03, 6078T57G04,
6078T57G05, and 6078T57G06 installed. These engines are installed
on, but not limited to, Bombardier Canadair airplane models CL-600-
2A12, -2B16, and -2B19.

Unsafe Condition

    (d) This AD results from a comment received on AD 2007-07-07,
and from GE recently issuing revisions to the applicable GE Alert
Service Bulletins (ASBs). We are issuing this AD to prevent an
uncontained fan disk failure and airplane damage.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified unless the
actions have already been done.

Removal of Certain Fan Disks From Service

    (f) For fan disks listed by P/N and serial number (SN) in the
following Table A that have fewer than 8,000 cycles-since-new (CSN)
on the effective date of this AD, replace fan disks before
accumulating 8,000 CSN:

   Table A.--Fan Disks That Require Removal Based on Blended Callouts
------------------------------------------------------------------------
               Disk part No.                       Disk serial No.
------------------------------------------------------------------------
6078T57G02................................  GAT6306N
6078T00G01................................  GAT3860G
6078T57G02................................  GAT1924L
5922T01G04................................  GAT9599G
6078T57G04................................  GEE05831
6078T57G04................................  GEE06612
6078T57G04................................  GEE06618
6078T57G04................................  GEE06974
6078T57G04................................  GEE06980
6078T57G05................................  GEE143FY
6078T57G05................................  GEE1453G
6078T57G05................................  GEE14452
6078T57G05................................  GEE145NA
6078T57G04................................  GEE08086
6078T57G04................................  GEE09287
6078T57G04................................  GEE09337
6078T57G05................................  GEE12720
6078T57G05................................  GEE14214
6078T57G05................................  GEE142YT
6078T57G05................................  GEE146GT
------------------------------------------------------------------------

    (g) For fan disks listed in Table A of this AD that have 8,000
CSN or more on the effective date of this AD, replace the disk
within 15 days after the effective date of this AD.

Inspections of Fan Disks Installed in Regional Jet Airplanes

    (h) For CF34-3A1 and CF34-3B1 turbofan engines installed on
Bombardier Canadair CL600-2B19 Regional Jet airplanes:

On-Wing Tactile and Enhanced Visual (TEV) Inspection

    (1) On-wing TEV inspect the fan disks listed by P/N and SN in
Table 1 of GE ASB No. CF34-AL S/B 72-A0231, Revision 1, dated June
27, 2007, using the compliance times specified in the following
Table B:

   Table B.--Regional Jet On-wing Fan Disk Inspection Compliance Times
------------------------------------------------------------------------
             For fan disks                           Inspect
------------------------------------------------------------------------
(i) That have not had a shop-level       Within 500 flight hours after
 inspection.                              the effective date of this AD.
(ii) That are marked with an asterisk    Within 500 flight hours after
 in Table 1 of GE ASB No. CF34-AL S/B     the effective date of this AD.
 72-A0231, Revision 1, dated June 27,
 2007.
------------------------------------------------------------------------

    (2) Use paragraphs 3.A. through 3.A.(13) of the Accomplishment
Instructions of GE ASB No. CF34-AL S/B 72-A0231, Revision 1, dated
June 27, 2007, to do the inspection.

Shop-Level Inspection

    (3) Within 5,000 flight hours or 5 calendar years after the
effective date of this AD, whichever occurs first, fluorescent
penetrant inspect (FPI), TEV inspect, and eddy current inspect (ECI)
at shop-level for cracks and electrical arc-out defects on the fan
disks listed by P/N and SN in Table 1 of GE ASB No. CF34-AL S/B 72-
A0233, Revision 3, dated June 27, 2007.
    (4) Use paragraphs 3.A.(1) through 3.A.(6) of the Accomplishment
Instructions of GE ASB No. CF34-AL S/B 72-A0233, Revision 3, dated
June 27, 2007, to do the inspections.

Shop-Level Inspection Exemption

    (5) Fan disks are exempt from the shop-level inspection, that
meet the following criteria:
    (i) Fan disks inspected before the effective date of this AD per
GE Engine Manual No. SEI-756, Section 72-21-00 (FAN ROTOR ASSEMBLY
INSPECTION); and
    (ii) That have accumulated no more than 100 cycles since that
inspection; and
    (iii) That pass the on-wing TEV inspection in paragraph (h)(2)
of this AD.

Inspection of Fan Disks Installed in Business Jet Airplanes

    (i) For CF34-1A, -3A, -3A1, -3A2, and -3B turbofan engines
installed on Bombardier Canadair Models CL-600-2A12 (CL-601), CL-
600-2B16 (CL-601-3A), (CL-601-3R), and (CL-604) Business Jet
airplanes:
    (1) FPI, TEV inspect, and ECI for cracks and electrical arc-out
defects at shop-level on the fan disks listed by P/N and SN in Table
1 of GE ASB No. CF34-BJ S/B 72-A0212, Revision 3, dated June 27,
2007, using the compliance times specified in the following Table C:

 Table C.--Business Jet Shop-level Fan Disk Inspection Compliance Times
------------------------------------------------------------------------
             For fan disks                           Inspect
------------------------------------------------------------------------
(i) That have not had a shop-level       Within 500 flight hours after
 inspection and have more than 5,500      the effective date of this AD.
 flight hours on the effective date of
 this AD.
(ii) That have not had a shop-level      Within accumulating a total of
 inspection and have 5,500 or fewer       6,000 fan disk operating hours-
 flight hours on the effective date of    since-new.
 this AD.

(iii) That have had a shop-level         Within accumulating an
 inspection and have 5,500 or fewer       additional 6,000 fan disk
 flight hours on the effective date of    operating hours-since-shop-
 this AD.                                 level inspection, or within 5
                                          calendar years from the
                                          effective date of this AD,
                                          whichever occurs first.
------------------------------------------------------------------------

    (2) Use paragraphs 3.A. through 3.A.(10) of the Accomplishment
Instructions of GE ASB No. CF34-BJ S/B 72-A0212, Revision 3, dated
June 27, 2007, to do the inspections.

Reporting Requirements

    (j) Under the provisions of the Paperwork Reduction Act of 1980
(44 U.S.C. 3501 et seq.), the Office of Management and Budget (OMB)
has approved the information collection requirements contained in
this AD, and has assigned OMB Control Number 2120-0056.
    (1) Report the results of the on-wing inspections performed in
paragraph (h)(2) of this AD by following the instructions in
paragraph 3.A.(14) of the Accomplishment Instructions of GE ASB No.
CF34-AL S/B 72-A0231, Revision 1, dated June 27, 2007.
    (2) Report the results of the shop-level inspections performed
in paragraph (h)(4) of this AD by following the instructions in
paragraph 3.A.(3)(b)11 of the Accomplishment Instructions of GE ASB
No. CF34-AL S/B 72-A0233, Revision 3, dated June 27, 2007.
    (3) Report the results of the shop-level inspections performed
in paragraph (i)(2) of this AD by following the instructions in
paragraph 3.A.(3)(b)11 of the Accomplishment Instructions of GE ASB
No. CF34-AL S/B 72-A0212, Revision 3, dated June 27, 2007.

Previous Credit

    (k) Credit is allowed for:
    (1) Fan disks previously shop-level inspected before the
effective date of this AD using GE ASB No. CF34-AL S/B 72-A0233,
dated March 7, 2007, Revision 1, dated March 16, 2007, or Revision
2, dated March 22, 2007; and GE ASB No. CF34-BJ S/B 72-A0212, dated
March 7, 2007, Revision 1, dated March 16, 2007, or Revision 2,
dated March 22, 2007.
    (2) Fan disks previously on-wing TEV inspected before the
effective date of this AD using GE ASB No. CF34-AL S/B 72-A0231,
dated March 7, 2007.

Alternative Methods of Compliance

    (l) The Manager, Engine Certification Office, has the authority
to approve alternative methods of compliance for this AD if
requested using the procedures found in 14 CFR 39.19.

Related Information

    (m) Emergency AD 2007-04-51 and AD 2007-05-16 also pertain to
the subject of this AD.

Material Incorporated by Reference

    (n) You must use the General Electric Company Alert Service
Bulletins listed in Table D of this AD to perform the inspections
required by this AD. The Director of the Federal Register approved
the incorporation by reference of the documents listed in Table D of
this AD in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You
can get a copy from General Electric Company via Lockheed Martin
Technology Services, 10525 Chester Road, Suite C, Cincinnati, Ohio
45215; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. You can review
copies at the FAA, New England Region, 12 New England Executive
Park, Burlington, MA; or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html
.

                                      Table D.--Incorporation by Reference
----------------------------------------------------------------------------------------------------------------
        Alert service bulletin no.                Page number         Revision                Date
----------------------------------------------------------------------------------------------------------------
CF34-AL S/B 72-A0231.....................  All.....................          1  June 27, 2007.
Total Pages: 94..........................
CF34-AL S/B 72-A0233.....................  All.....................          3  June 27, 2007.
Total Pages: 92..........................
CF34-BJ S/B 72-A0212.....................  All.....................          3  June 27, 2007.
Total Pages: 96..........................
----------------------------------------------------------------------------------------------------------------

    Issued in Burlington, Massachusetts, on August 16, 2007.
Peter A. White,
Acting Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
 [FR Doc. E7-16554 Filed 8-27-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Notices]
[Pages 45894-45895]
[FR Doc No: 2020-16530]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1551]

Pregnancy, Lactation, and Reproductive Potential: Labeling for
Human Prescription Drug and Biological Products--Content and Format;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Pregnancy,
Lactation, and Reproductive Potential: Labeling for Human Prescription
Drug and Biological Products--Content and Format.'' This draft guidance
is intended to assist applicants in complying with the content and
format requirements of the Pregnancy, Lactation, and Females and Males
of Reproductive Potential subsections of labeling for human
prescription drug and biological products. This draft guidance revises
the draft guidance issued in December 2014. This revision provides
clarification and additional information on recommendations to
applicants submitting new drug applications (NDAs), biologics license
applications (BLAs) (for biological products that are regulated as
drugs), and efficacy supplements to approved NDAs or BLAs.

DATES: Submit either electronic or written comments on the draft
guidance by September 28, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-1551 for ``Pregnancy, Lactation, and Reproductive Potential:
Labeling for Human Prescription Drug and Biological Products--Content
and Format.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit

both copies to the Dockets Management Staff. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or Office
of Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Denise Johnson-Lyles, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6469, Silver Spring, MD 20993-0002, 301-
796-6169; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Pregnancy, Lactation, and Reproductive Potential: Labeling
for Human Prescription Drug and Biological Products--Content and
Format.'' The final rule, Content and Format of Labeling for Human
Prescription Drug and Biological Products; Requirements for Pregnancy
and Lactation Labeling, referred to as the PLLR, which published
December 4, 2014 (79 FR 72063), modified the labeling requirements for
human prescription drug and biological products. The PLLR amended FDA's
regulations governing the content and format of the ``Pregnancy,''
``Labor and Delivery,'' and ``Nursing Mothers'' subsections of the
``Use in Specific Populations'' section of the existing labeling for
human prescription drug and biological products. This guidance is
intended to assist applicants in complying with the content and format
requirements of the ``Pregnancy,'' ``Lactation,'' and ``Females and
Males of Reproductive Potential'' subsections of labeling for human
prescription drug and biological products, as described in the PLLR.
This draft guidance revises the draft guidance of the same name issued
December 4, 2014 (79 FR 72104). The revisions provide clarification and
additional information on recommendations in response to public
comments and the Agency's regulatory experience implementing the PLLR.
Changes to this draft guidance from the previous draft guidance include
the addition of the following:
     Information on formatting, omitting information, and
pregnancy registries.
     Clarifying information related to the Risk Summary
heading, risk statements, and human and animal data.
     Information on labeling for section 8.3 Females and Males
of Reproductive Potential, including information on pregnancy testing,
contraception, and infertility.
     Procedural information on implementation and submission of
draft labeling to the Agency for review.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Pregnancy,
Lactation, and Reproductive Potential: Labeling for Human Prescription
Drug and Biological Products--Content and Format.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3521) is not required.
    However, this draft guidance refers to previously approved
collections of information. These collections of information are
subject to review by the OMB under the PRA. The collection of
information in 21 CFR 201.56 and 201.57 for preparing and submitting
labeling has been approved under OMB control number 0910-0572. The
collections of information in 21 CFR 314.70 and 314.97 for submitting
supplements to an approved application, in 21 CFR 314.50(e) for
submitting labeling for an application, and in 21 CFR 314.90 for
submitting waiver requests for an application have been approved under
OMB control number 0910-0001. The collection of information in 21 CFR
601.12 for submitting supplements to an approved application has been
approved under OMB control number 0910-0338. In addition, the
information collection provisions of the PLLR have been approved under
OMB control number 0910-0624.

III. Electronic Access

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

    Dated: July 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-16530 Filed 7-29-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: June 8, 2010 (Volume 75, Number 109)]
[Rules and Regulations]
[Page 32260-32262]
[DOCID:fr08jn10-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0982; Directorate Identifier 2009-NE-19-AD;
Amendment 39-16323; AD 2010-12-02]
RIN 2120-AA64

Airworthiness Directives; Turbomeca S.A. MAKILA 1A and 1A1
Turboshaft Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) issued by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    The installation of TU250 comparator/selector (CS) boards,
however, has resulted in a few occurrences of erratic engine
behaviour, in the form of unexpected N1 variations and/or
illumination of the ``GOV'' warning light. The conclusions from an
investigation by Turbom[eacute]ca are that these malfunctions are
due to a lapse of quality control in the varnishing process applied
to the boards, and that only boards in a specific serial number
range, as defined under ``Applicability'' and referred to below as
the ``suspect batch'', are affected.

We are issuing this AD to prevent loss of automatic engine control
during flight due to an uncommanded engine roll-back, which could
result in the inability to continue safe flight.

DATES: This AD becomes effective July 13, 2010. The Director of the
Federal Register approved the incorporation by reference of certain
publications listed in this AD as of July 13, 2010.

ADDRESSES: The Docket Operations office is located at Docket Management
Facility, U.S. Department of Transportation, 1200 New Jersey Avenue,
SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-
0001.

FOR FURTHER INFORMATION CONTACT: Kevin Dickert, Aerospace Engineer,
Engine Certification Office, FAA, Engine and Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on March 31, 2010 (75
FR 16022). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states that:

    The installation of TU250 CS boards, however, has resulted in a
few occurrences of erratic engine behaviour, in the form of
unexpected N1 variations and/or illumination of the ``GOV'' warning
light. The conclusions from an investigation by Turbomeca are that
these malfunctions are due to a lapse of quality control in the
varnishing process applied to the boards, and that only boards in a
specific serial number range, as defined under ``Applicability'' and
referred to below as the ``suspect batch'', are affected.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Costs of Compliance

    Based on the service information, we estimate that this AD will
affect about 10 products of U.S. registry. We also estimate that it
will take about 1 work-hour per product to comply with this AD. The
average labor rate is $85 per work-hour. Required parts will cost about
$3,500 per product. Based on these figures, we estimate the cost of the
AD on U.S. operators to be $35,850.

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.
    We are 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

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will 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 AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;

    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (phone<PHONE_NUMBER>) is provided in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 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 AD:

2010-12-02 Turbomeca S.A.: Amendment 39-16323. Docket No. FAA-2009-
0982; Directorate Identifier 2009-NE-19-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective July 13,
2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Turbomeca S.A. Makila 1A and 1A1
turboshaft engines with a comparator/selector (CS) board, part
number (P/N) 0 177 99 716 0, and a serial number (S/N) between 241EL
and 1192EL (inclusive) installed. These engines are installed on,
but not limited to, Eurocopter AS 332 C, AS 332 C1, AS 332 L, and AS
332 L1 helicopters.

Reason

    (d) The European Aviation Safety Agency (EASA) AD 2009-0090,
dated April 28, 2009, states that this AD results from the
following:
    (1) The installation of TU250 CS boards, however, has resulted
in a few occurrences of erratic engine behaviour, in the form of
unexpected N1 variations and/or illumination of the ``GOV'' warning
light. The conclusions from an investigation by Turbom[eacute]ca are
that these malfunctions are due to a lapse of quality control in the
varnishing process applied to the boards, and that only boards in a
specific serial number range, as defined under ``Applicability'' and
referred to below as the ``suspect batch'', are affected.
    (2) We are issuing this AD to prevent loss of automatic engine
control during flight due to an uncommanded engine roll-back, which
could result in the inability to continue safe flight.

Actions and Compliance

    (e) Unless already done, do the following actions.
    (1) Within 50 operating hours from the effective date of this
AD, replace any CS board, P/N 0 177 99 716 0, with a S/N from 241EL
to 1192EL (inclusive), that has fewer than 200 hours-since-new
(HSN). Use paragraph 2 of Turbomeca S.A. Mandatory Service Bulletin
(MSB) No. 298 73 0809 Version A, dated February 12, 2008, to replace
the boards.
    (2) During the next 500-hour inspection, replace any CS board,
P/N 0 177 99 716 0, with a S/N from 241EL to 1192EL (inclusive),
that has 200 HSN or more. Use paragraph 2 of Turbomeca S.A. MSB No.
298 73 0810 Version B, dated April 27, 2009, to replace the boards.

FAA AD Differences

    (f) This AD differs from the Mandatory Continuing Airworthiness
Information (MCAI) and/or service information as follows:
    (1) This AD requires replacing within 50 operating hours after
the effective date of this AD, all comparator/selector boards, P/N 0
177 99 716 0, with an S/N from 241EL to 1192EL (inclusive) that have
fewer than 200 HSN.
    (2) This AD requires replacing at the next 500-hour routine
inspection after the effective date of this AD, all comparator/
selector boards, P/N 0 177 99 716 0, with a S/N from 241EL to 1192EL
(inclusive) that have 200 HSN or more.

Alternative Methods of Compliance (AMOCS)

    (g) The Manager, Engine Certification Office, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19.

Related Information

    (h) Refer to MCAI EASA Airworthiness Directive 2009-0090, dated
April 28, 2009, for related information.
    (i) Contact Kevin Dickert, Aerospace Engineer, Engine
Certification Office, FAA, Engine and Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>,
for more information about this AD.

Material Incorporated by Reference

    (j) You must use the service information specified in Table 1 of
this AD to do the actions required by this AD, unless the AD
specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Turbomeca, 40220 Tarnos, France; telephone 33 05 59 74 40 00; fax 33
05 59 74 45 15.
    (3) You may review copies at the FAA, New England Region, 12 New
England Executive Park, Burlington, MA; or at the National Archives
and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go
to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

                                   Table 1--Material Incorporated by Reference
----------------------------------------------------------------------------------------------------------------
Turbomeca mandatory Service Bulletin
                 No.                            Page               Version                    Date
----------------------------------------------------------------------------------------------------------------
298 73 0809.........................
    Total Pages: 7                    ALL....................               A  February 12, 2008.
298 73 0810.........................
    Total Pages: 7                    ALL....................               B  April 27, 2009.
----------------------------------------------------------------------------------------------------------------

    Issued in Burlington, Massachusetts, on May 24, 2010.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2010-13433 Filed 6-7-10; 8:45 am]
BILLING CODE 4910-13-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request USEPA\ Office of Air and Radiation\ Office of Transportation and Air Quality 2. OMB control number b. G None a 2060 0078 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. x Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. x Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes XG No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title: Mobile Source Emission Factor On Highway Recruitment 8. Agency form number( s) ( If applicable): EPA ICR No. 0619.10 9. Keywords Mobile Source, On Highway, Vehicle Emissions, In use, Recruitment, Emission Factors 10. Abstract The EPA, Office of Transportation and Air Quality ( OTAQ), Assessment and Standards Division ( ASD) administers a nationwide effort to collect data on emission levels from in use vehicles recruited from the general public voluntarily. ASD carries out this effort through the Emission Factor Program ( EFP). EFP gathers activity and emissions measurements by either sampling a vehicle's emissions and activity during normal operation or alternatively its emissions are measured under one or many simulations developed for laboratory testing using a chassis dynamometer.

11. Affected public ( Mark primary with " P" and all others that apply with " X")

a. P Individuals or households d. Farms b. x Business or other for profit e. x Federal Government c. x Not for profit institutions f. x State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X")

a. P Voluntary b. G Required to obtain or retain benefits c. G Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 420 b. Total annual responses 420 1. Percentage of these responses collected electronically 0% c. Total hours requested 883 d. Current OMB inventory 1,649 e. Difference  766 f. Explanation of difference 1. Program Change  766 2. Adjustment 0 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs $ 0 b. Total annual costs ( O& M) $ 0 c. Total annualized cost requested $ 0 d. Current OMB inventory $ 0 e. Difference $ 0 f. Explanation of difference 1. Program change $ 0 2. Adjustment $ 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X")

a. x Application for benefits e. x Program planning or management b. x Program evaluation f. P Research c. General purpose statistics g. x Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. x Recordkeeping b. Q Third party disclosure c. x Reporting 1. x On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods? X Yes Q No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Carl A Scarbro Phone: 734.214.4209 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Date Signature of Senior Official or designee Doreen Sterling, Acting Director Collection Strategies Division Office of Environmental Information Date OMB 83 I ( Instructions) 10/ 95