[Federal Register Volume 76, Number 187 (Tuesday, September 27, 2011)]
[Notices]
[Pages 59705-59706]
[FR Doc No: 2011-24739]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0108]

Guidance for Industry on User Fee Waivers, Reductions, and
Refunds for Drug and Biological Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``User Fee Waivers,
Reductions, and Refunds for Drug and Biological Products.'' This
guidance provides recommendations to applicants considering whether to
request a waiver or reduction in user fees. This guidance is a revision
of the draft guidance entitled ``Draft Interim Guidance Document for
Waivers of and Reductions in User Fees,'' issued July 16, 1993.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach, and Development (HFM-40), Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448. 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.
    Submit electronic comments on this guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
Michael Jones, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6216, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``User Fee Waivers, Reductions, and Refunds for Drug and
Biological Products.'' This guidance provides recommendations for
applicants planning to request waivers or reductions in user fees
assessed under sections 735 and 736 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 379g and 379h, respectively).
This guidance describes the types of waivers and reductions permitted
under the user fee provisions of the FD&C Act and the procedures for
submitting requests for waivers or reductions and requests for
reconsideration and appeal. The guidance also provides clarification on
related issues such as user fee exemptions for orphan drugs.
    In the Federal Register of March 14, 2011 (76 FR 13629), FDA
announced the availability of a revised draft guidance entitled ``User
Fee Waivers, Reductions, and Refunds for Drug and Biological
Products.'' The notice gave interested persons the opportunity to
comment by June 13, 2011. We received no comments on the revised draft
guidance; however, we have made minor editorial changes and a small
clarification to the guidance document.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on user fee waivers and reductions for drug
products. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this guidance were approved under OMB
control number 0910-0639. The guidance also refers to collections of
information for filling out and submitting Form FDA 3397 (Prescription
Drug User Fee Coversheet), previously approved under OMB control number
0910-0297, and collections of information associated with new drug
applications or biologics license applications approved under OMB
control numbers 0910-0001 and 0910-0338, respectively.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or at http://www.regulations.gov.

    Dated: September 21, 2001.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24739 Filed 9-26-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 126 (Tuesday, July 1, 2014)]
[Proposed Rules]
[Pages 37246-37248]
[FR Doc No: 2014-15378]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0424; Directorate Identifier 2014-NM-003-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Bombardier, Inc. Model BD-700-1A10 and BD-700-1A11 airplanes.
This proposed AD was prompted by reports of an incorrectly assembled
check tee fitting used in fire extinguishing (FIREEX) distribution
lines. This proposed AD would require inspecting to determine the part
number and for all affected check tee fittings measuring for correct
depth, and replacing if necessary. We are proposing this AD to detect
and correct faulty check tee fittings, which will reduce fire
extinguishing protection.

DATES: We must receive comments on this proposed AD by August 15, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact--
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.com. You
may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0424; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Cesar Gomez, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-0424;
Directorate Identifier 2014-NM-003-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Transport Canada Civil Aviation, which is the aviation authority
for Canada, has issued Canadian Airworthiness Directive CF-2013-41,
dated December 30, 2013 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for the specified products. The MCAI states:

    A check tee fitting used in the aeroplane fire extinguishing
(FIREEX) distribution lines, was discovered by another airframe
manufacturer as being incorrectly assembled. A properly assembled
check tee fitting normally contains one check ball, however the
affected fitting contained two check balls. The FIREEX manufacturer
advised Bombardier that this condition may be present on aeroplane
models BD-700-1A10 and BD-700-1A11.
    Testing has verified that incorrect installation of the
additional check ball in the fitting reduces the flow rate of the
extinguishing agent. There are three check tee fittings installed on
the BD-700-1A10 and BD-700-1A11 aeroplanes, one for each engine and
one for the auxiliary power unit. Faulty fittings will reduce fire
extinguishing protection at the affected locations.
    Bombardier has issued several Alert Service Bulletins (ASBs) to
identify, inspect and replace if required, all affected fittings.
This [Canadian] AD mandates incorporation of the applicable
Bombardier ASBs to rectify this problem.

    Required actions include inspecting to determine the part number
and for all affected check tee fittings measuring for correct depth,
and replacing if necessary. You may examine the MCAI in the AD docket
on the Internet at http://www.regulations.gov by searching for and
locating it in Docket No. FAA-2014-0424.

Relevant Service Information

    Bombardier, Inc. has issued the following service bulletins. The
actions described in this service information are intended to correct
the unsafe condition identified in the MCAI.
     Bombardier Alert Service Bulletin A700-1A11-26-003, dated
April 18, 2013 (for Model BD-700-1A11 (BD-700) airplanes having S/Ns
9127 through 9383 inclusive; 9389 through 9400 inclusive, 9404 through
9431 inclusive, and 9998).
     Bombardier Alert Service Bulletin A700-26-010, dated April
18, 2013 (for Model BD-700-1A10 (BD-700) airplanes having S/Ns 9002
through 9312 inclusive, 9314 through 9380 inclusive, and 9384 through
9429 inclusive).
     Bombardier Alert Service Bulletin A700-26-5002, dated
April 18, 2013 (for Model BD-700-1A11 (BD-700) airplanes having S/Ns
9386, 9401, and 9445 through 9498 inclusive).
     Bombardier Alert Service Bulletin A700-26-6002, dated
April 18, 2013 (for Model BD-700-1A10 (BD-700) airplanes having S/Ns
9313, 9381, and 9432 through 9500 inclusive).

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    We estimate that this proposed AD affects 57 airplanes of U.S.
registry.
    We also estimate that it would take about 1 work-hour per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Required parts would cost about $0 per
product. Based on these figures, we estimate the cost of this proposed
AD on U.S. operators to be $4,845, or $85 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 1 work-hour, for a cost of $85 per tee fitting. We have no
way of determining the number of aircraft that might need this action.
    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our 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.
    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 proposed 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 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. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. 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.

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 (AD):

Bombardier, Inc.: Docket No. FAA-2014-0424; Directorate Identifier
2014-NM-003-AD.

(a) Comments Due Date

    We must receive comments by August 15, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc. Model BD-700-1A10 and BD-
700-1A11 airplanes, certificated in any category, serial numbers
9002 through 9500 inclusive, and 9998.

(d) Subject

    Air Transport Association (ATA) of America Code 26, Fire
Protection.

(e) Reason

    This AD was prompted by reports of an incorrectly assembled
check tee fitting used in fire extinguishing (FIREEX) distribution
lines. We are issuing this AD to detect and correct faulty check tee
fittings, which will reduce fire extinguishing protection.

(f) Compliance

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

(g) Part Number Identification

    Within 100 flight hours or 180 days, whichever occurs first
after the effective date of this AD, inspect to determine the part
number (P/N) of the fire extinguishing (FIREEX) check tee fitting,
in accordance with the Accomplishment Instructions of the applicable
service bulletin identified in paragraph (g)(1), (g)(2), (g)(3), or
(g)(4) of this AD.
    (1) Bombardier Alert Service Bulletin A700-1A11-26-003, dated
April 18, 2013 (for Model BD-700-1A11 (BD-700) airplanes having S/Ns
9127 through 9383 inclusive; 9389 through 9400 inclusive, 9404
through 9431 inclusive, and 9998).
    (2) Bombardier Alert Service Bulletin A700-26-010, dated April
18, 2013 (for Model BD-700-1A10 (BD-700) airplanes having S/Ns 9002
through 9312 inclusive, 9314 through 9380 inclusive, and 9384
through 9429 inclusive).
    (3) Bombardier Alert Service Bulletin A700-26-5002, dated April
18, 2013 (for Model BD-700-1A11 (BD-700) airplanes having S/Ns 9386,
9401, and 9445 through 9498 inclusive).
    (4) Bombardier Alert Service Bulletin A700-26-6002, dated April
18, 2013 (for Model BD-700-1A10 (BD-700) airplanes having S/Ns 9313,
9381, and 9432 through 9500 inclusive).

(h) Measurement and Replacement

    If any inspection specified in paragraph (g) of this AD reveals
any check tee fitting having P/N 446651 and S/N 062 through 070
inclusive, 117 through 133 inclusive, 3728 through 3731 inclusive,
3733 through 3760 inclusive, or 3762 through 3776 inclusive: Within
100 flight hours or 180 days, whichever occurs first after the
effective date of this AD, measure the depth of the inlet fitting of
the check tee, in accordance with the Accomplishment Instructions of
the applicable service bulletin identified in paragraph (g)(1),
(g)(2), (g)(3), or (g)(4) of this AD. If the check tee depth is less
than 1.70 inches (4.32 cm), before further flight, replace the check
tee in accordance with the Accomplishment Instructions of the
applicable service bulletin identified in paragraph (g)(1), (g)(2),
(g)(3), or (g)(4) of this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, 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 local Flight
Standards District Office, as appropriate. If sending information
directly to the ACO, send it to ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer, use these actions if they
are FAA-approved. Corrective actions are considered FAA-approved if
they were approved by the State of Design Authority (or its
delegated agent, or the DAH with a State of Design Authority's
design organization approval, as applicable). You are required to
ensure the product is airworthy before it is returned to service.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2013-41, dated December
30, 2013, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating it in Docket No. FAA-2014-0424.
    (2) For Bombardier service information identified in this AD,
contact Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; email<EMAIL_ADDRESS>Internet http://www.bombardier.com. You may view this service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

     Issued in Renton, Washington, on June 19, 2014.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-15378 Filed 6-30-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Pages 81601-81602]
[FR Doc No: 2010-32510]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM08-19-002]

North American Electric Reliability Corporation; Notice of
Compliance Filing

December 20, 2010.
    Take notice that on December 1, 2010, North American Electric
Reliability Corporation, in response to Paragraph 274 of the Federal
Energy Regulatory Commission's (Commission) Order No. 729 issued on
November 24, 2009,\1\ submitted a compliance filing of proposed
Violation Risk Factors and Violation Severity Levels for Available
Transfer Capability Reliability Standards.
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    \1\ Mandatory Reliability Standards for the Calculation of
Available Transfer Capability, Capacity Benefit Margins,
Transmission Reliability Margins, Total Transfer Capability, and
Existing Transmission Commitments and Mandatory Reliability
Standards for the Bulk-Power System, 129 FERC ] 61, 155 (2009).
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call

(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on January 10, 2011.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-32510 Filed 12-27-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Notices]
[Pages 48077-48078]
[FR Doc No: 2017-22350]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ -OW-2002-0011; FRL-9969-53-OW]

Proposed Information Collection Request; Comment Request;
Laboratory Quality Assurance Evaluation Program for Analysis of
Cryptosporidium Under the Safe Drinking Water Act (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Laboratory Quality Assurance
Evaluation Program for Analysis of Cryptosporidium Under the Safe
Drinking Water Act'' (EPA ICR No. 2067.06, OMB Control No. 2040-0246)
to the Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. Before doing so, EPA is
soliciting public comments on specific aspects of the proposed
information collection request as described below. This is a proposed
extension of the ICR, which is currently approved through March 31,
2018. 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.

DATES: Comments must be submitted on or before December 15, 2017.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2002-0011, online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public 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.

FOR FURTHER INFORMATION CONTACT: Dan Hautman, Technical Support Center
(TSC), Office of Ground Water and Drinking Water, (MC-140),
Environmental Protection Agency, 26 West Martin Luther King Drive,
Cincinnati, Ohio 45268; telephone number:<PHONE_NUMBER>; fax number:
513-569-7191; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) 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; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) 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. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: Under the Long Term 2 Enhanced Surface Water Treatment
Rule (LT2ESWTR), EPA requires public water systems (PWSs) to use
approved laboratories when conducting Cryptosporidium monitoring. The
Code of Federal Regulations (CFR) at 40 CFR 141.705(a) provides for
approval of Cryptosporidium laboratories by ``an equivalent'' state
laboratory certification program (i.e., equivalent to EPA's Laboratory
Quality Assurance Evaluation Program). In the preamble to the LT2ESWTR
as well as several other notices, EPA has described the criteria for
approval of laboratories to analyze Cryptosporidium samples under the
LT2ESWTR. See the following Federal Register notices: 78 FR 54643
(September 5, 2013), 74 FR 8529 (February 25, 2009), 71 FR 727 (January
5, 2006) and 67 FR 9731 (March 4, 2002).

    State responsibilities for Cryptosporidium laboratory approval and
oversight will be comparable to their certification responsibilities
for the chemistry and microbiology laboratories that they oversee in
their current programs (e.g., initial evaluation of laboratory
capability; ongoing assessment of the laboratory--including an
assessment of Proficiency Test results; and on-site audits, at least
triennially). Whereas 40 CFR 142.10(b) generally requires the
establishment and maintenance of a laboratory ``certification'' program
for all regulated analytes, state approval programs for Cryptosporidium
laboratories are optional based on the structure of the LT2ESWTR (40
CFR 141.705(a)).
    If a laboratory is located in a state that does not operate a
Cryptosporidium laboratory certification/accreditation program, that
laboratory can still support LT2ESWTR monitoring if the laboratory has
been approved by another state's laboratory certification/accreditation
program that: (1) Has demonstrated substantial conformity to procedures
described in Chapter 7 of ``Supplement 2 to the Fifth Edition of the
Manual for the Certification of Laboratories Analyzing Drinking Water''
https://www.epa.gov/dwlabcert/supplement-2-fifth-edition-manual-certification-laboratories-analyzing-drinking-water; and (2) uses
auditors that have passed EPA's Technical Support Center's (TSC)
Cryptosporidium Laboratory Certification Officers Training Course. PWSs
should be aware that their states may establish requirements that are
more stringent than EPA's regulations; state requirements would take
precedence.
    Consistent with the longstanding laboratory certification program
approach, and resources-permitting, TSC will: (1) Train state/regional
Certification Officers (CO) responsible for auditing Cryptosporidium
laboratories; (2) provide written guidance to state/regional COs; (3)
provide day-to-day technical support to states, EPA Regions, and
laboratories; (4) review/assist the regional programs that oversee
state certification/accreditation programs; and (5) maintain a list of
links to state Web sites naming certified laboratories and/or a list of
certified laboratories on EPA's Web site.
    Form Numbers: None.
    Respondents/affected entities: Interested states and laboratories.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 43 labs and 20 states/territories.
    Frequency of response: Annual.
    Total estimated burden: 3,741 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $669,490, includes $332,891 annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is decrease of 1,731 hours and $134,284
in the total estimated respondent burden compared with the ICR
currently approved by OMB. This decrease is due to a reduced number of
laboratories (45 to 43), re-evaluation of hours for tasks, and an
improved demonstration of capability by the laboratories.

    Dated: October 4, 2017.
Peter Grevatt,
Director, Office of Ground Water and Drinking Water.
[FR Doc. 2017-22350 Filed 10-13-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: January 18, 2006 (Volume 71, Number 11)]
[Notices]
[Page 2975]
[DOCID:fr18ja06-90]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53068; File No. SR-Phlx-2005-87]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Notice of Filing and Order Granting Accelerated Approval to a Proposed
Rule Change, and Amendment No. 1 Thereto Relating to the Exchange's
Covered Sale Fee and Exchange Rule 607

January 11, 2006.

Correction

    The release number for File No. SR-Phlx-2005-87 issued on January
6, 2006 was incorrectly stated as Release No. 34-53088. The correct
release number appears above.

Nancy M. Morris,
Secretary.
 [FR Doc. E6-431 Filed 1-17-06; 8:45 am]

BILLING CODE 8010-01-P


Ron Evans/RTP/USEPA/US

08/27/2008 10:45 AM

To

"King, Heidi R."<EMAIL_ADDRESS>
cc

Al McGartland, Alexander Cristofaro/DC/USEPA/US@EPA, Charlotte
Bertrand/DC/USEPA/US@EPA, <EMAIL_ADDRESS>Brian Heninger, Lydia
Wegman, rosalina rodriguez, kathy kaufman, darryl weatherhead,
<EMAIL_ADDRESS><EMAIL_ADDRESS>Charles Fulcher/RTP/USEPA/US@EPA,
Tricia Crabtree/RTP/USEPA/US@EPA

Subject

Pb NAAQS RIA analysis data requested at meeting on 8/18

Heidi, here is the supporting data which Art Fraas requested during the
Pb NAAQS RIA cost meeting on 8/18.   The list of requested items is
below, with a brief explanation of what is provided.   Please let Kathy
or I know if you have any questions.

1.	Cost/ton by control measure

This data is provided in the attached excel file.  We have provided the
average cost/ton for each measure applied as part  of the 0.1 ug/m3
identified controls analysis.

A unique control measure is the combination of the control measure and
the source category to which it is applied.

2.	$/ug for geographic areas where large sources (sources between
10-20km from monitor) were included in the analysis.

The air quality modelers suggested that sources greater than 10
kilometers from the monitor would have no appreciable effect in either
reality or in our simplified distance weighted monitor to emission
source model.

We screened the impact of including large sources located 10 to 20
kilometers from the monitor to see if adding the sources would result in
more attainment with identified control.   For the 0.1 standard the
change only affected three areas.  One of them, Salt Lake, UT, was
already reaching attainment but was overshooting the standard because of
lumpiness of available control options and the addition of large sources
made no significant change.   Adding the sources for Berks, PA reduced
the progress towards attainment.  For Cuyahoga, OH adding the sources
did not change the emission reductions but did lead to a slight
reduction in the baseline air quality after the adjustment for MACTs and
hence the post identified control air quality was slightly better.

Because of these small and sometimes counterintuitive changes and the
likelihood that these sources would neither actually contribute or be
chosen for control we will not pursue a scenario that includes sources
further than 10 kilometers from the monitor.

3.	Number of sources per geographic area

This data is provided in the 2nd tab of the attached excel file.  We
have provided the number of point source emission points included in the
analysis.

Please note: emission point does not equal the number of plants, as a
single plant may have many emission points.  Also, the number of
emission points does not equal the number of emission points with
controls applied to them.

Ron Evans

Leader, Air Benefit & Cost Group

HEID/OAQPS/OAR/EPA

Mail Drop C-439-02

919-541-5488

919-541-0839 fax


[Federal Register: August 1, 2006 (Volume 71, Number 147)]
[Notices]
[Page 43553-43554]
[DOCID:fr01au06-103]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54220; File No. SR-NYSE-2006-52]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change by
New York Stock Exchange LLC Relating to Amendments to Exchange Rule
629--Schedule of Fees

July 26, 2006.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 \3\ thereunder, notice is hereby
given that on July 21, 2006, New York Stock Exchange LLC (``NYSE'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the NYSE. NYSE has filed the proposal as a
``non-controversial'' proposed rule change pursuant to Section
19(b)(3)(A) \4\ of the Act, and Rule 19b-4(f)(6) \5\ thereunder, which
renders the proposal as effective immediately upon filing. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
    \4\ 15 U.S.C. 78s(b)(3)(A).
    \5\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NYSE is proposing an amendment to Rule 629 to clarify the hearing
deposits required for customer counterclaims, third party claims, and
cross-claims.
    The text of the proposed rule change is available on NYSE's Web
site (http://www.nyse.com), at the NYSE's Office of the Secretary, and

at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the NYSE included statements
concerning the purpose of and basis for the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below.
    The NYSE has prepared summaries, set forth in Sections A, B, and C
below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    NYSE Rule 629 (``Rule 629'') sets forth the schedules of fees for
hearing deposits required by the parties when filing claims,
counterclaims, third party claims and cross-claims. The hearing
deposits differ for customer and industry claimants.
    NYSE proposes to amend Rule 629 to clarify that the hearing
deposits required of customers who file counterclaims, third party
claims and cross-claims [in an industry initiated dispute] are the same
as the hearing deposits for matters in which a customer is the
claimant.
2. Statutory Basis
    NYSE believes the proposed changes are consistent with Section
6(b)(4) \6\ of the Act, which requires that an exchange have rules that
provide for the equitable allocation of reasonable dues, fees, and
other charges among its members and other persons using its facilities.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The NYSE does not believe that the proposed rule change will impose
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The NYSE has neither solicited nor received written comments on the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect

the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) \7\ of the Act and Rule 19b-4(f)(6) \8\
thereunder.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.
    NYSE has requested that the Commission waive the 30-day operative
delay contained in Rule 19b-4(f)(6)(iii) \9\ under the Act based upon a
representation that the proposed rule change accurately reflects the
fees imposed pursuant to Rule 629 and will provide further
clarification regarding hearing deposits required for customers filing
counterclaims, third party claims and cross-claims in industry
initiated disputes. In light of the foregoing, the Commission believes
such waiver is consistent with the protection of investors and the
public interest. Accordingly, the Commission designates the proposal to
be effective and operative upon filing with the Commission.\10\
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(f)(6)(iii).
    \10\ For purposes only of waiving the 30-day operative delay of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, is consistent with the Act. Comments may be
submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send e-mail to<EMAIL_ADDRESS>Please include File

Number SR-NYSE-2006-52 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC, 20549-1090.

All submissions should refer to File Number SR-NYSE-2006-52. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro/shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing will also be available for inspection and copying at the
principal office of the NYSE. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File number SR-NYSE-2006-52 and should be submitted on or before August
22, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
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J. Lynn Taylor,
Assistant Secretary.
 [FR Doc. E6-12323 Filed 7-31-06; 8:45 am]

BILLING CODE 8010-01-P