[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Pages 35778-35779]
[FR Doc No: 2016-13165]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0446]

Expanded Access to Investigational Drugs for Treatment Use--
Questions and Answers; 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 guidance for industry entitled ``Expanded Access
to Investigational Drugs for Treatment Use--Questions and Answers.''
The guidance provides information for industry, researchers,
physicians, institutional review boards (IRBs), and patients about the
implementation of FDA's regulations on expanded access to
investigational drugs for treatment use under an investigational new
drug application (IND). FDA received a number of questions concerning
implementation of its expanded access regulations and is providing
guidance in a question and answer format to address the most frequently
asked questions. This guidance finalizes the draft guidance issued in
May 2013.

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

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2013-D-0446 for ``Expanded Access to Investigational Drugs for
Treatment Use--Questions and Answers; Guidance for Industry;
Availability.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    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: Ebla Ali Ibrahim, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6302, Silver Spring, MD 20993, 301-796-
3691; 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 guidance for industry
entitled ``Expanded Access to Investigational Drugs for Treatment Use--
Questions and Answers.'' FDA's expanded access regulations (21 CFR part
312, subpart I) went into effect on October 13, 2009 (74 FR 40900).
Expanded access refers to the use of an investigational drug when the
primary purpose is to diagnose, monitor, or treat a patient rather than
to obtain the kind of information about the drug that is generally
derived from clinical trials. Under the regulations, there are three
categories of expanded access: (1) Expanded access for individual
patients, including for emergency use; (2) expanded access for
intermediate-size patient populations (generally smaller than those
typical of a treatment IND or treatment protocol--a treatment protocol
is submitted as a

protocol amendment to an existing IND by the sponsor of the existing
IND); and (3) expanded access for widespread treatment use through a
treatment IND or treatment protocol (designed for use in larger patient
populations). The regulations are intended to facilitate, when
appropriate, the availability of investigational new drugs outside of a
clinical investigation or approved drugs where availability is limited
by a risk evaluation and mitigation strategy (REMS) to patients with
serious or immediately life-threatening diseases or conditions who lack
other therapeutic options.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of a guidance for industry entitled ``Charging for
Investigational Drugs Under an IND--Questions and Answers,'' which
provides information about the implementation of FDA's regulation on
charging for investigational drugs under an IND, including
investigational drugs made available for expanded access use. (FDA's
guidance documents are available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. FDA has
verified the Web site addresses throughout this document, as of the
date this document publishes in the Federal Register, but Web sites are
subject to change over time.)
    Additionally, in this issue of the Federal Register, FDA is
announcing the availability of a guidance for industry entitled
``Individual Patient Expanded Access Applications: Form FDA 3926.'' The
guidance describes Form FDA 3926 (Individual Patient Expanded Access--
Investigational New Drug Application (IND)), which is available for
licensed physicians to use for expanded access requests for individual
patient INDs as a streamlined alternative to Form FDA 1571
(Investigational New Drug Application (IND)), and describes the process
for submitting expanded access requests for individual patient expanded
access INDs.
    One of FDA's major goals in promulgating the expanded access
regulations was to make expanded access a more transparent process by
increasing awareness and knowledge about expanded access and the
procedures for obtaining investigational drugs for treatment use. Since
the expanded access regulations went into effect in 2009, FDA has
received a number of questions concerning implementation of the
regulations. Consistent with the goal of making expanded access
processes more transparent, FDA is providing guidance in a question and
answer format to address questions about how FDA is implementing its
expanded access regulations, including questions about when it is
appropriate to request expanded access under each of the three expanded
access categories, the types and content of expanded access
submissions, IRB review of individual patient expanded access, and the
onset and duration of expanded access use.
    In the Federal Register of May 9, 2013 (78 FR 27115), FDA announced
the availability of the draft guidance entitled ``Expanded Access to
Investigational Drugs for Treatment Use--Questions & Answers.'' FDA
received several comments on the draft guidance, and those comments
were considered as the guidance was finalized. Based on public
comments, in addition to editorial changes made primarily for
clarification, the final guidance includes significant clarification on
the types of expanded access and when each type should be used.
    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 expanded access to investigational drugs for
treatment use. 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

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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 21 CFR part 312 have been approved under
OMB control number 0910-0014, and the collection of information
resulting from the submission of Form FDA 3926 has been approved under
OMB control number 0910-0814.

III. Electronic Access

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

    Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13165 Filed 6-2-16; 8:45 am]
 BILLING CODE 4164-01-P


75651 Federal Register / Vol. 65, No. 233 / Monday, December 4, 2000 / Proposed Rules TABLE 1.Ð WASTE EXCLUDED FROM NON SPECIFIC SOURCESÐ Continued Facility Address Waste description *******

TABLE 2.Ð WASTE EXCLUDED FROM SPECIFIC SOURCES Facility Address Waste description ******* Eastman Chemical Company ................ Longview, Texas ..... Wastewater treatment sludge, (at a maximum generation of 82,100 cubic yards per calendar year) (EPA Hazardous Waste Nos. K009, K010) generated at Eastman. Eastman must implement the testing program described in Table 1 of this Appendix. Waste Excluded From Non Specific Sources for the petition to be valid.

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TABLE 3.Ð WASTE EXCLUDED FROM COMMERCIAL CHEMICAL PRODUCTS, OFF SPECIFICATION SPECIES, CONTAINER RESIDUES, AND SOIL RESIDUES THEREOF Facility Address Waste description Eastman Chemical Company ................ Longview, Texas .... Wastewater treatment sludge, (at a maximum generation of 82,100 cubic yards per calendar year) generated by Eastman (EPA Hazardous Waste Nos. U001, U002, U028, U031, U069, U088, U112, U115, U117, U122, U140, U147, U154, U159, U161, U220, U226, U239, U359). Eastman must implement the testing program described in Table 1 of this Appendix. Waste Excluded From Non Specific Sources for the petition to be valid.

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[FR Doc. 00± 30632 Filed 12± 1± 00; 8: 45 am]

BILLING CODE 6560± 50± P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 268 [FRL± 6910± 9]

Land Disposal Restrictions: Notice of Intent to Grant a Site Specific Treatment Variance to Dupont Environmental TreatmentÐ Chambers Works Wastewater Treatment Plant, Deepwater, New Jersey AGENCY: Environmental Protection Agency. ACTION: Proposed rule.

SUMMARY: The Environmental Protection Agency (EPA or Agency) is proposing to grant a site specific treatment variance from the Land Disposal Restrictions (LDR) standards for wastewater treatment sludge generated at the Dupont Environmental Treatment (DET)Ð Chambers Works Wastewater Treatment Plant located in Deepwater, New Jersey. This sludge is derived from the treatment of multiple listed, including K088, and characteristic hazardous waste. DET requests this treatment variance because they contend that the chemical properties of the sludge differ significantly from the waste used to establish the LDR treatment standard for arsenic in K088 nonwastewaters. Accordingly, we propose to grant an alternate treatment standard of 5.0 mg/ L Toxicity Characteristic Leaching Procedure (TCLP) for the arsenic in the wastewater treatment sludge generated at this facility. If promulgated, DET may then dispose of their wastewater treatment sludge in their on site RCRA Subtitle C landfill provided the sludge complies with the specified alternate treatment standard for arsenic in K088 nonwastewaters and meets all other applicable LDR treatment standards. DATES: Comments must be received by December 26, 2000. Comments received after the close of the comment period will be stamped `` late'' and may or may not be considered by the Agency. ADDRESSES: Commenters should submit an original and two copies of their comments referencing Docket Number F± 2000± DPVP± FFFFF to: (1) If using regular U. S. Postal Service mail: RCRA Docket Information Center, Office of Solid Waste (5305G), U. S. Environmental Protection Agency Headquarters (EPA± HQ), 1200 Pennsylvania Avenue, NW, Washington DC 20460± 0002, or (2) if using special delivery, such as overnight express service: RCRA Docket Information Center (RIC), Crystal Gateway One, 1235 Jefferson Davis Highway, First Floor, Arlington, VA 22202. You may view public comments and supporting materials in the RCRA Information Center (RIC), located at Crystal Gateway I, First Floor, 1235 Jefferson Davis Highway, Arlington, VA. The RIC is open from 9 am to 4 pm Monday through Friday, excluding federal holidays. To review docket materials, we recommend that you make an appointment by calling 703± 603± 9230. You may copy up to 100 pages from any regulatory document at no charge. Additional copies cost $0.15 per page. (The index is available electronically. See the SUPPLEMENTARY INFORMATION section for information on accessing them).

FOR FURTHER INFORMATION CONTACT: For general information, call the RCRA Hotline at 1± 800± 424± 9346 or TDD 1± 800± 553± 7672 (hearing impaired). The RCRA Hotline is open Monday Friday, 9 am to 6 pm, Eastern Standard Time. For more detailed information on specific aspects of this proposal, contact Elaine VerDate 11< MAY> 2000 15: 22 Dec 01, 2000 Jkt 194001 PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 04DEP1. SGM pfrm08 PsN: 04DEP1 75652 Federal Register / Vol. 65, No. 233 / Monday, December 4, 2000 / Proposed Rules 1 For purposes of this document, the term sludge, waste water treatment plant sludge, dewatered sludge, biosludge, and dewatered biosludge are used interchangeably and refer to the treated waste that has been dewatered and subject to analytical testing. Eby at 703± 308± 8449, eby. elaine@ epa. gov, or write her at the Office of Solid Waste, 5302W, U. S. Environmental Protection Agency, Ariel Rios Building, 1200 Pennsylvania Avenue, NW, Washington, DC 20460± 0002.

SUPPLEMENTARY INFORMATION:

Electronic Comment Submission You may submit comments electronically by sending electronic mail through the Internet to: rcradocket epa. gov. You should identify comments in electronic format with the docket number F± 2000± DPVP± FFFFF. You must submit all electronic comments as an ASCII (text) file, avoiding the use of special characters or any type of encryption. If possible, EPA's Office of Solid Waste (OSW) would also like to receive an additional copy of the comments on disk in WordPerfect 6.1 file format. You should not submit electronically any confidential business information (CBI). You must submit an original and two copies of CBI under separate cover to: RCRA CBI Document Control Officer, Office of Solid Waste (5305W), U. S. EPA, 1200 Pennsylvania Avenue, NW, Washington DC 20460± 0002.

Availability of Rule on Internet Please follow these instructions to access the rule: From the World Wide Web (WWW), type http:// www. epa. gov/ epaoswer/ hazwaste/ ldr/ index. html. The official record for this action will be kept in paper form. Accordingly, EPA will transfer all comments received electronically into paper form and place them in the official record which will also include all comments submitted directly in writing. The official record is the paper record maintained at the RIC listed in the ADDRESSES section at the beginning of this document. EPA's responses to comments, whether the comments are written or electronic, will be published in the Federal Register or in a response to comments document placed in the official record for this action. EPA will not immediately reply to commenters electronically other than to seek clarification of electronic comments that may be garbled in transmission or during conversion to paper form, as discussed above.

How Can I Influence EPA's Thinking on This Rule?

We invite you to provide different views on options we propose, new approaches we haven't considered, new data, how this rule may effect you, or other relevant information. Your comments will be most effective if you follow the suggestions below: · Explain your views as clearly as possible and why you feel that way. · Provide solid technical data to support your views. · Tell us which parts you support, as well as those you disagree with. · Provide specific examples to illustrate your concerns. · Offer specific alternatives. · Make sure to submit your comments by the deadline in this notice. · Be sure to include the name, date, and docket number with your comments. The Agency will consider the public comments during development of the final rule related to this action. The Agency urges commenters submitting data in support of their views to include data evidence that appropriate quality assurance/ quality control (QA/ QC) procedures were followed in generating the data. Data the Agency cannot verify through QA/ QC documentation may be given less consideration or disregarded in developing regulatory options for the final rule. For guidance see Final Best Demonstrated Available Technology (BDAT) Background Document for Quality Assurance/ Quality Control Procedures and Methodology; USEPA, October 23, 1991.

Table of Contents I. Why and How Are Treatment Variances Granted? II. Why is Dupont Environmental Treatment Seeking a Treatment Variance? III. EPA's Analysis of DET's Petition IV. EPA's Proposal to Grant a Site Specific Treatment Variance to DET V. Administrative Requirements A. Regulatory Impact Analysis Pursuant to Executive Order 12866 B. Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U. S. C. 601 et seq. C. Unfunded Mandates Reform Act D. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks E. Environmental Justice Executive Order 12898 F. Paperwork Reduction Act G. National Technology Transfer and Advancement Act of 1995 H. Executive Order 13084: Consultation and Coordination with Indian Tribal Governments I. Executive Order 13132 (Federalism)

I. Why and How Are Treatment Variances Granted?

Under section 3004( m) of the Resource Conservation and Recovery Act (RCRA) as amended by the Hazardous and Solid Waste Amendments of 1984, EPA is required to set `` levels or methods of treatment, if any, which substantially diminish the toxicity of the waste or substantially reduce the likelihood of migration of hazardous constituents from the waste so that short term and long term threats to human health and the environment are minimized. '' We have interpreted this language to authorize treatment standards based on the performance of best demonstrated available technology (BDAT). This interpretation was sustained by the court in Hazardous Waste Treatment Council vs. EPA, 886 F. 2d 355 (D. C. Cir. 1989). We recognize that there may be wastes that cannot be treated to levels specified in the regulation (see 40 CFR 268.40) (51 FR 40576, November 7, 1986). For such wastes, a treatment variance exists (40 CFR 268.44) that, if granted, becomes the treatment standard for the waste at issue. Treatment variances may be generic or site specific. A generic variance can result in the establishment of a new treatability group and a corresponding treatment standard that applies to all wastes that meet the criteria of the new waste treatability group (55 FR 22526, June 1, 1990). A site specific variance applies only to a specific waste from a specific facility. Under 40 CFR 268.44( h), a generator or treatment facility may apply to the Administrator, or EPA's delegated representative, for a site specific variance in cases where a waste that is generated under conditions specific to only one site and cannot or should not be treated to the specified level( s). The applicant for a site specific variance must demonstrate that because the physical or chemical properties of the waste differ significantly from the waste analyzed in development of the treatment standard, the waste cannot be treated by BDAT to the specified levels or by the specified method( s). Although there are other grounds for obtaining treatment variances, we will not discuss those in this notice because this is the only provision relevant to the present petition. Dupont Environmental TreatmentÐ Chambers Works submitted their request for a treatment variance in February 2000. All information and data used in the development of this proposal can be found in the RCRA docket supporting this rule. 1 VerDate 11< MAY> 2000 15: 22 Dec 01, 2000 Jkt 194001 PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 04DEP1. SGM pfrm08 PsN: 04DEP1 75653 Federal Register / Vol. 65, No. 233 / Monday, December 4, 2000 / Proposed Rules 2 In addition to the F039 and K088 waste designations, this wastewater contains eighteen additional RCRA hazardous waste codes. 3 On September 21, 1998, EPA promulgated interim replacement standards for K088 waste. (See 63 FR 51254, September 24, 1998). As part of that rulemaking, the treatment standard for arsenic in K088 nonwastewaters was set at 26.1 mg/ kg. That standard has been in effect since September 21, 1998 and applies to all K088 treatment sludge generated at DET WWTP since the effective date. 4 Compliance data are generated by a contract laboratory based on TCLP analysis for metals on a secondary sludge sample from the treatment operation. The analysis is done quarterly for monitoring LDR compliance in accordance with DET's waste analysis plan. The compliance analysis for the TCLP extraction follows EPA protocol as specified in SW± 846, Method 1311. Metals analysis is run by inductively coupled plasma via SW± 846 Method 6010B, except for mercury which is done by SW± 846 Method 7470A. Appropriate quality assurance/ quality control is conducted by the contract laboratory in accordance with SW± 846 requirements. DET's compliance data submitted to the Agency for the last quarter of 1998 show total arsenic concentrations in the WWTP sludge of 16 mg/ kg. Quarterely compliance testing for 1999 show total asenic concentrations of 13.0, 12.3, 10.0 and <9.9 mg/ kg. All TCLP data for arsenic in the WWTP sludge show concentrations of arsenic less than 0.10 mg/ L. 5 It should be noted that the WWTP sludge at issue here is generated by the biological treatment of a relatively small quantity of wastewater carrying the K088 waste designation. This K088 wastewater accounts for less than 0.002% of the total annual throughput at DET WWTP. II. Why is Dupont Environmental Treatment Seeking a Treatment Variance?

Dupont Environmental TreatmentÐ Chambers Works (herein referred to as `` DET'') operates a wastewater treatment plant (herein referred to as `` WWTP'') in Deepwater, New Jersey. The wastewater treatment performed at this facility can be described as an enhanced biological degradation system consisting of neutralization, equalization, primary clarification, secondary aeration and clarification, tertiary aeration and clarification, and sludge dewatering. Various pretreatment operations also are conducted on site. DET WWTP operates as both a commercial treatment facility, for industrial and RCRA hazardous waste, and as an internal treatment operation, for Dupont's numerous manufacturing operations. DET WWTP processes approximately 16 million gallons of wastewater per day or 5.84 billion gallons per year, making it the largest wastewater treatment facility in the United States. In December 1997, DET entered into a contractual agreement with Safety Kleen, Incorporated to treat wastewater from Safety Kleen's Waynoka, Oklahoma facility. The wastewater consists of approximately 87% multisource leachate from an on site Subtitle C landfill in Oklahoma (F039 waste) and 13% commercial wastewater pretreated by Safety Kleen. A portion of this commercial wastewater was shipped to Safety Kleen as K088 waste, i. e., potliner waste from primary aluminum reduction, originating as landfill leachate from a Reynolds Metals Company facility in Gum Springs, Arkansas. During the last three months of 1998, Safety Kleen shipped 192,000 gallons of this wastewater, i. e., the multi source leachate and the commercial wastewater, to DET for treatment. In 1999, Safety Kleen transported approximately 1.3 million gallons of additional wastewater to DET. 2 In February 2000, DET concluded, albeit belatedly, that there was a possibility that the continued treatment of Safety Kleen's wastewater, containing the K088 waste designation, at their WWTP could result in noncompliance for DET's WWTP sludge with the K088 nonwastewater treatment standard for total arsenic. 3 While compliance monitoring samples, taken since October 1998, show that the dewatered sludge meets both the Universal Treatment Standard (UTS) for arsenic of 5.0 mg/ L TCLP and the K088 arsenic treatment standard of 26.1 mg/ kg, screening samples taken in 1999 suggest that the total arsenic concentration in the dewatered sludge could exceed the 26.1 mg/ kg treatment standard in future compliance monitoring tests. 4 However, these data do not meet EPA quality assurance and quality control requirements. Therefore, it is impossible for us to rely on these data in our deliberations. On February 28, 2000, DET submitted a petition to EPA requesting a treatment variance from the K088 treatment standard for arsenic nonwastewaters generated at their facility. DET acknowledges that the WWTP sludge has not yet exceeded the treatment standard, based on compliance testing samples taken since late 1998. However, DET is concerned that, in the future, the sludge may exceed the treatment standard. DET states that, even if the arsenic standard is exceeded, the total arsenic concentration can not be reduced to meet the existing treatment standard. DET believes that requesting a treatment variance prior to an actual violation of the treatment standard is an appropriate and necessary action. As part of their petition, in accordance with the requirements of 40 CFR 268.44, DET contends that their waste, i. e., the dewatered WWTP sludge carrying the K088 waste designation, differs significantly from the waste used to establish the treatment standard for total arsenic in K088 waste. DET states that the dewatered sludge is at least a second derivative treatment residue that bears no resemblance, in physical form or composition, to generated potliners or typically thought of generated residues from potliner treatment. DET maintains that for their waste, the TCLP is an appropriate analytical test for measuring arsenic mobility because of the neutral pH characteristic of the sludge. Additionally, DET states that no further treatment can be applied to the sludge because arsenic is an element, and as such cannot be destroyed to meet the existing treatment standardÐ a totals analysis test. Based on these findings, DET requests that EPA grant a variance from the 26.1 mg/ kg treatment standard for arsenic in K088 nonwastewaters for their wastewater treatment sludge. DET requests an alternative standard of 5.0 mg/ L TCLP for arsenic in K088 waste. This level is the same as the old treatment standard for arsenic in K088 nonwastewaters, i. e., the standard that existed prior to the September 21, 1998 rulemaking and the current UTS for arsenic nonwastewaters. DET contends that the old standard is more appropriate for their waste because: (1) the TCLP measures mobility of arsenic; (2) the sludge's neutral pH is well suited for evaluating whether arsenic could migrate and cause harm to human health and the environment; and (3) the arsenic in the WWTP sludge cannot be destroyed.

III. EPA's Analysis of DET's Petition As just discussed, the waste at issue here is a dewatered WWTP sludge resulting from the treatment of wastewater carrying the K088 waste designation. 5 We agree with DET's main pointÐ that this waste is significantly different from the waste on which the 26.1 mg/ kg standard for total arsenic in K088 nonwastewaters is based. In addition, we agree that there is no available treatment to reduce the amount of total arsenic contained in the waste. The 26.1 mg/ kg standard for arsenic in K088 waste, promulgated in 1998, was developed based on performance data from a high temperature thermal treatment process for spent aluminum potliners from primary aluminum reduction used at a Reynolds Metals facility in Gum Springs, Arkansas. Specifically, the treatment standard was derived from an assay of the total acid soluble arsenic in K088 waste after spent potliner had been crushed, mixed with lime and sand, and sent through a VerDate 11< MAY> 2000 15: 22 Dec 01, 2000 Jkt 194001 PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 04DEP1. SGM pfrm08 PsN: 04DEP1 75654 Federal Register / Vol. 65, No. 233 / Monday, December 4, 2000 / Proposed Rules 6 Compliance monitoring samples taken quarterly in 1999 show that the pH landfill leachate values at DET's onsite hazardous waste landfill, where the WWTP sludge was disposed were as follows: 7.46, 8.35, 6.59, and 8.34. high temperature rotary kiln resulting in a fused waste residue. As previously discussed, prior to 1998, the treatment standard for arsenic was 5.0 mg/ L TCLP, based on the Reynolds treatment process that, at that time, treated much of the K088 generated in the United States (63 FR 51257, September 24, 1998). However, to address subsequent concerns regarding the elevated concentrations of arsenic in Reynold's landfill leachate, Reynolds changed the type of sand used in their thermal process to a sand with lower concentrations of arsenic. These 1998 revisions, to the K088 arsenic standards, were intended to cap arsenic concentrations in the treated potliner and to lock in the Reynolds treatment process change, i. e., the change in sand type. Therefore, the reason for our shift to a 26.1 mg/ kg total arsenic standard has no basis in appropriate treatment levels for WWTP sludge carrying the K088 waste code solely due to the derived from regulations. In addition, Reynolds thermal treatment of K088 waste generates an extremely alkaline residue for which the TCLP was found to be a poor predictor of arsenic mobility. See Columbia Falls v. EPA, 139F. 3d 914 (D. C. Cir 1998); see also 63 FR 28571, May 26, 1998 (EPA's interpretation of the court's opinion). This decision also provided additional impetus for our 1998 change to a total arsenic standard. As previously noted, the WWTP sludge from DET, conversely, is not alkaline. It is at a pH between 6.5 and 7.5 to ensure no adverse effect on the treatment microbes, and the expected sludge disposal conditions at DET are also in a neutral pH range. 6 Based on this information, we conclude that an alternative treatment standard of 5.0 mg/ L TCLP for arsenic in K088 dewatered sludge generated at DET's WWTP is warranted for several reasons. First, the sludge generated at DET's WWTP is not the same type of waste that was used to develop the 26.1 mg/ kg treatment standard for arsenic in K088 nonwastewaters, nor does it present the same situation regarding the use of a total arsenic standard to lockin treatment process parameters. Second, the sludge will be disposed of in a Subtitle C hazardous waste landfill with pH conditions in the range of 6.5 to 8.5 and not under the alkaline conditions, i. e., pH conditions of 12 and above, that resulted in mobilization of arsenic at Reynold's K088 landfill. Thus, the conditions that prompted the change in the K088 treatment standard are absent for this site. Third, the TCLP remains an adequate measure of treatment efficiency for DET's WWTP sludge due to the non alkaline sludge matrix and the expected disposal conditions. Therefore, we believe that a TCLP standard of 5.0 mg/ L is a reasonable measure of demonstrating that threats posed by the waste's disposal have been minimized. Fourth, the alternative standard of 5.0 mg/ L TCLP is currently the standard applicable to arsenic in all other hazardous wastes, except K088 nonwastewaters. Fifth, data submitted to the Agency shows that DET's dewatered WWTP sludge consistently maintains both a neutral pH and TCLP levels of arsenic far less than 5.0 mg/ L. Finally, arsenic concentrations in the WWTP sludge cannot be treated to a lower treatment standard based on a totals analysis, i. e., arsenic must be immobilized, as an element cannot be destroyed.

IV. EPA's Proposal to Grant a SiteSpecific Treatment Variance to DET Based on these conclusions, we propose to grant DET's petition for a site specific treatment variance for their WWTP sludge. After consideration of public comment and a determination to grant this variance, we will amend 40 CFR part 268 to state that wastewater treatment sludge generated by Dupont Environmental TreatmentÐ Chambers Works Wastewater Treatment Plant in Deepwater, New Jersey is subject to an arsenic treatment standard of 5.0 mg/ L TCLP for all RCRA wastes. We also will stipulate that the waste must be land disposed in their on site Subtitle C landfill assuming the waste meets all applicable federal, state and local requirements.

V. Administrative Requirements A. Regulatory Impact Analysis Pursuant to Executive Order 12866 Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether a regulatory action is `` significant'' and therefore subject to OMB review and the requirements of the Executive Order. The Order defines `` significant regulatory action'' as one that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Because this proposed rule does not create any new regulatory requirements, it is not a `` significant regulatory action'' under the terms of Executive Order 12866 and is therefore not subject to OMB review.

B. Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U. S. C. 601 et seq.

The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not for profit enterprise which is independently owned and operated and is not dominant in its field. After considering the economic impacts of today's proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This proposed rule will not impose any requirements on small entities. This treatment variance does not create any new regulatory requirements. Rather, it establishes an alternative treatment standard for a regulated constituent. This action, therefore, does not require a regulatory flexibility analysis.

C. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104± 4, establishes requirements for Federal Agencies to assess the effects of their regulatory actions on State, local,

VerDate 11< MAY> 2000 15: 22 Dec 01, 2000 Jkt 194001 PO 00000 Frm 00020 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 04DEP1. SGM pfrm08 PsN: 04DEP1 75655 Federal Register / Vol. 65, No. 233 / Monday, December 4, 2000 / Proposed Rules and tribal governments and the private sector. Under Section 202 of the UMRA, EPA generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with `` Federal mandates'' that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most costeffective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing education, and advising small governments on compliance with the regulatory requirements. EPA has determined that this proposed rule does not include a Federal mandate that may result in estimated costs of $100 million or more in the aggregate to either State, local, or tribal governments or the private sector in one year. The proposed rule would not impose any federal intergovernmental mandate because it imposes no enforceable duty upon State, tribal or local governments. States, tribes, and local governments would have no compliance costs under this rule. EPA has also determined that this proposal contains no regulatory requirements that might significantly or uniquely affect small governments. In addition, as discussed above, the private sector is not expected to incur costs exceeding $100 million. EPA has fulfilled the requirement for analysis under the Unfunded Mandates Reform Act. D. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) is determined to be `` economically significant'' as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. Today's proposed rule is not subject to Executive Order 13045 because it does not meet either of these criteria. The subject wastes will comply with all other treatment standards and be disposed of in a RCRA Subtitle C landfill. Therefore, we have identified no risks that may disproportionately affect children.

E. Environmental Justice Executive Order 12898 EPA is committed to addressing environmental justice concerns and is assuming a leadership role in environmental justice initiatives to enhance environmental quality for all residents of the United States. The Agency's goals are to ensure that no segment of the population, regardless of race, color, national origin, or income bears disproportionately high and adverse human health and environmental impacts as a result of EPA's policies, programs, and activities, and that all people live in clean and sustainable communities. In response to Executive Order 12898 and to concerns voiced by many groups outside the Agency, EPA's Office of Solid Waste and Emergency Response formed an Environmental Justice Task Force to analyze the array of environmental justice issues specific to waste programs and to develop an overall strategy to identify and address these issues (OSWER Directive No. 9200.3± 17). Today's proposed rule applies to wastes that will be treated and disposed of in a RCRA Subtitle C hazardous waste landfill, ensuring a high degree of protection to human health and the environment. Therefore, the Agency does not believe that today's action will result in any disproportionately negative impacts on minority or low income communities relative to affluent or non minority communities.

F. Paperwork Reduction Act This proposed rule would only change the treatment standards applicable to a subcategory of K088 wastes and does not change in any way the paperwork requirements already applicable to these wastes, it does not affect requirements under the Paperwork Reduction Act.

G. National Technology Transfer and Advancement Act of 1995 As noted in the proposed rule, section 12( d) of the National Technology Transfer and Advancement Act of 1995 (`` NTTAA''), Public Law 104± 113, section 12( d) (15 U. S. C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e. g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This action does not involve technical standards based on new methodologies. Therefore, EPA did not consider the use of any voluntary consensus standards.

H. Executive Order 13084: Consultation and Coordination with Indian Tribal Governments Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected and other representatives of Indian tribal governments `` to provide meaningful and timely input to the development of VerDate 11< MAY> 2000 15: 22 Dec 01, 2000 Jkt 194001 PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 04DEP1. SGM pfrm08 PsN: 04DEP1 75656 Federal Register / Vol. 65, No. 233 / Monday, December 4, 2000 / Proposed Rules regulatory policies on matters that significantly or uniquely affect their communities. '' Today's proposal does not significantly or uniquely affect the communities of Indian tribal governments. Today's proposal does not create a mandate on State, local or tribal governments, The proposal would not impose any enforceable duties on these entities. Accordingly, the requirements of section 3( b) of Executive Order 13084 do not apply to this proposed rule.

I. Executive Order 13132 (Federalism)

Executive Order 13132, entitled `` Federalism'' (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implication. '' `` Policies that have federalism implication'' is defined in the Executive Order to include regulation that have `` substantial direct effects 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 governments. '' Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local government, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that had federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing proposed regulation. If EPA complies by consulting Executive Order 13132, it requires EPA to provide to the Office of Management and Budget (OMB), in a separately identified section of the preamble to the rule, a federalism summary impact statement (FSIS). The FSIS must include a description of the extent of EPA's prior consultation with State and local officials, a summary of the nature of their concerns and the Agency's position supporting the need to issue the regulation, and a statement of the extent to which the concerns of state and local officials have been met. Also when EPA transmits a draft final rule with federalism implication to OMB for review pursuant to Executive Order 12866, EPA must include a certification from the Agency's Federalism Official stating that EPA has met the requirements of Executive Order 13132 in a meaningful and timely manner. This proposed rule will not have substantial direct effects 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, as specified in Executive Order 13132. Thus the requirements of section 6 of the Executive Order do not apply to this proposed rule.

List of Subjects in 40 CFR Part 268 Environmental protection, Hazardous waste, Reporting and recordkeeping requirements.

Dated: November 6, 2000. Timothy Fields, Jr., Assistant Administrator for Solid Waste and Emergency Response.

For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is proposed to be amended as follows: 1. The authority citation for part 268 continues to read as follows:

Authority: 42 U. S. C. 6905, 6912( a), 6921, and 6924.

2. In § 268.44, the table in paragraph (o) is amended by adding in alphabetical order a new entry for `` Dupont Environmental TreatmentÐ Chambers Works Wastewater, Deepwater, NJ'' to read as follows:

PART 268Ð LAND DISPOSAL RESTRICTIONS.

* * * * *

§ 268.44 Variance from a treatment standard.

* * * * * (o) * * *

TABLEÐ WASTES EXCLUDED FROM THE TREATMENT STANDARDS UNDER § 268.40 Facility name 1 and address Waste code See also Regulated hazardous constituent Wastewaters Nonwastewaters Concentration (mg/ l) Notes Concentration (mg/ kg) Notes *******

Dupont Environmental Treatment Chambers Works Wastewater Treatment Plant, Deepwater, NJ. K088 Standards under § 268.40 .... Arsenic .......... 1.4 NA 5.0 mg/ L TCLP NA *******

1 A facility may certify compliance with these treatment standards according to provisions in 40 CFR 268.7. ***** Note: NA means Not Applicable.

* * * * * [FR Doc. 00± 30637 Filed 12± 1± 00; 8: 45 am]

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[Federal Register Volume 78, Number 72 (Monday, April 15, 2013)]
[Rules and Regulations]
[Pages 22175-22178]
[FR Doc No: 2013-08570]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1036; Directorate Identifier 2011-NM-122-AD;
Amendment 39-17408; AD 2013-07-04]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are superseding an existing airworthiness directive (AD)
for certain Airbus Model A319, A320, and A321 series airplanes. That AD
currently requires installing spacer assemblies at the attachment
points of the YZ-latches of the cargo loading system (CLS) in the
forward and aft cargo compartments, as applicable. This new AD also
requires modifying the attachment points of fixed YZ-latches of the CLS
lower deck cargo holds on those airplanes on which one or both lower
deck cargo holds have not been modified, which terminates the existing
requirements. This AD was prompted by results from tests that have
shown that the attachment points of the YZ-latches of the cargo loading
system (CLS) fail under maximum loads and reports that installation has
been applied only on one of the lower deck cargo holds, instead of on
both forward and aft cargo holds, and that some airplanes could have
installed the affected YZ-latches through the instructions of the cargo
conversion manual. We are issuing this AD to prevent failure of the
attachment points of the YZ-latches, which could result in unrestrained
cargo causing damage to the fire protection system, hydraulic system,
electrical wiring, or other equipment located in the forward and aft
cargo compartments. This damage could adversely affect the continued
safe flight of the airplane.

DATES: This AD becomes effective May 20, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 20,
2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of April
12, 2007 (72 FR 10348, March 8, 2007).

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; 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 October 4, 2012 (77
FR 60653), and proposed to supersede AD 2007-05-13, Amendment 39-14974
(72 FR 10348, March 8, 2007). That NPRM proposed to correct an unsafe
condition for the specified products. The Mandatory Continuing
Airworthiness Information (MCAI) states:

    Investigation has revealed that the installed Tie Down Points of
YZ latches on the Cargo Loading System (CLS) of Airbus A319, A320
and A321 aeroplanes do not withstand the

maximum loads in accordance with the certification requirements (CS
25.787 ``Stowage compartments'').
    In case of failure of Tie Down Points, unrestrained cargo parts
could cause damage in the Forward (FWD) and AFT lower deck cargo
holds (e.g. air conditioning, fire protection system, hydraulic
system, electrical wiring, etc.), and therefore could have an impact
on the safety of the flight.
    EASA AD 2006-0184 [ which corresponds to FAA AD 2007-05-13,
Amendment 39-14974 (72 FR 10348, March 8, 2007)] was issued to
require the modification of the attachment points of fixed YZ
latches of the CLS in both FWD and AFT lower deck cargo holds, as
applicable to aeroplane configuration, in accordance with Airbus SB
A320-25-1294 Revision 01.
    It has recently been identified that for some aeroplanes, Airbus
SB A320-25-1294 Revision 01 has been applied only on one of the
lower deck cargo holds (FWD or AFT) while both cargo compartments
were concerned by the modification, and that some aeroplanes could
have installed the affected YZ [latches] through the instructions of
the Cargo Conversion Manual.
    For the reasons described above, this [EASA] AD, which
supersedes EASA AD 2006-0184, requires modification of the
attachment points of fixed YZ latches of the CLS lower deck cargo
holds on those aeroplanes on which one or both lower deck cargo
holds have not been modified.
    This [EASA] AD also prohibits installation of the affected YZ
latches, identified by Part Number (P/N) in Table 1 of Appendix 1 of
this [EASA] AD, on any aeroplane as replacement parts, unless all
the attachment points of the YZ latch have been modified.

    You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received.

Request To Clarify Terminating Action

    Airbus requested that we clarify the paragraph identifier specified
in the last sentence of paragraph (g) of the NPRM (77 FR 60653, October
4, 2012). Airbus suggested that the correct identifier should be
paragraph (h) instead of paragraph (i) of the NPRM.
    We agree with the commenter and have revised paragraph (g) of this
AD accordingly.

Request To Revise Airbus Contact Information

    Airbus requested that we revise the contact information reference
to the Airbus office of airworthiness from EAW to EIAS.
    We agree and have revised the contact information specified in
paragraph (l)(2) of this AD.

Additional Change Made to This AD

    We have removed table 1 to paragraph (h) from this AD. Instead, we
have listed the subject part numbers in paragraphs (h)(1) through
(h)(7) of this AD. This change does not affect the intent of that
paragraph.

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously--and minor editorial
changes. We have determined that these changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 60653, October 4, 2012) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 60653, October 4, 2012).

Costs of Compliance

    We estimate that this AD will affect about 740 products of U.S.
registry.
    The actions that are required by AD 2007-05-13, Amendment 39-14974
(72 FR 10348, March 8, 2007), and retained in this AD take about 4
work-hours per product, at an average labor rate of $85 per work-hour.
Required parts cost about $2,049 per product. Based on these figures,
the estimated cost of the currently required actions is $2,389 per
product.
    We estimate that it will take about 15 work-hours per product to
comply with the new basic requirements of this AD. The average labor
rate is $85 per work-hour. Required parts will cost up to $2,656 per
product. Where the service information lists required parts costs that
are covered under warranty, we have assumed that there will be no
charge for these parts. As we do not control warranty coverage for
affected parties, some parties may incur costs higher than estimated
here. Based on these figures, we estimate the cost of this AD to the
U.S. operators to be up to $2,908,940, or $3,931 per product.

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 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);
    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.
    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 the NPRM (77 FR 60653, October 4,
2012), the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is 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

    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 removing airworthiness directive (AD)
2007-05-13, Amendment 39-14974 (72 FR 10348, March 8, 2007), and adding
the following new AD:

2013-07-04 Airbus: Amendment 39-17408. Docket No. FAA-2012-1036;
Directorate Identifier 2011-NM-122-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective May 20,
2013.

(b) Affected ADs

    This AD supersedes AD 2007-05-13, Amendment 39-14974 (72 FR
10348, March 8, 2007).

(c) Applicability

    This AD applies to Airbus Model A319-111, -112, -113, -114, -
115, -131, -132, and -133 airplanes; Model A320-111, -211, -212, -
214, -231, -232, and -233 airplanes; and Model A321-111, -112, -131,
-211, -212, -213, -231, and -232 airplanes; certificated in any
category; all manufacturer serial numbers.

(d) Subject

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

(e) Reason

    This AD was prompted by results from tests that have shown that
the attachment points of the YZ-latches of the cargo loading system
(CLS) fail under maximum loads and reports that installation has
been applied only on one of the lower deck cargo holds, instead of
on both forward and aft cargo holds, and that some airplanes could
have installed the affected YZ-latches through the instructions of
the cargo conversion manual. We are issuing this AD to prevent
failure of the attachment points of the YZ-latches, which could
result in unrestrained cargo causing damage to the fire protection
system, hydraulic system, electrical wiring, or other equipment
located in the forward and aft cargo compartments. This damage could
adversely affect the continued safe flight of the airplane.

(f) Compliance

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

(g) Retained Spacer Assembly Installation

    This paragraph restates the requirements of paragraph (f) of AD
2007-05-13, Amendment 39-14974 (72 FR 10348, March 8, 2007). For
Airbus Model A319, A320, and A321 series airplanes identified in
paragraphs (g)(1) and (g)(2) of this AD: Within 36 months after
April 12, 2007 (the effective date of AD 2007-05-13), install spacer
assemblies at the attachment points of the YZ-latches of the CLS in
the forward and aft cargo compartments, as applicable, in accordance
with the Accomplishment Instructions of Airbus Service Bulletin
A320-25-1294, Revision 02, dated September 5, 2006. Accomplishing
the actions in paragraph (h) of this AD terminates the requirements
of paragraph (g) of this AD.
    (1) Airplanes on which one of the following has been
incorporated in production: Airbus Modification 20065, 20040, 24495,
24848, 24496, 21895, 21896, 25905, 25907, 22601, 22602, 27187,
28319, 28322, 28330, 28335, or 31797.
    (2) Airplanes on which one of the following has been
incorporated in service: Airbus Service Bulletin A320-25-1132, A320-
25-1133, A320-25-1145, A320-25-1175, A320-25-1177, A320-25-1276,
A320-25-1278, A320-28-1134, or A320-28-1141.

(h) New Modification

    Except for Model A319, A320, and A321 series airplanes on which
both Airbus Modifications 32244 and 32245, or both Airbus
Modifications 32316 and 32317, have been incorporated in production,
and on which no YZ-latch replacements have been made since first
flight: Within 20 months after the effective date of this AD, modify
the attachment points of fixed YZ-latches of the CLS, having a part
number (P/N) listed in paragraphs (h)(1) through (h)(7) of this AD,
in both forward and aft lower deck cargo holds by adding spacer
assemblies having P/N D2557232700000, in accordance with the
Accomplishment Instructions of Airbus Mandatory Service Bulletin
A320-25-1294, Revision 06, dated July 23, 2010. Accomplishing the
actions specified in paragraph (h) of this AD terminates the
requirements of paragraph (g) of this AD.
    (1) P/N D 255 7 2380 000.
    (2) P/N D 255 7 2380 002.
    (3) P/N D 255 7 2380 006.
    (4) P/N D 255 7 2380 008.
    (5) P/N D 255 7 2350 002.
    (6) P/N D 255 7 2350 004.
    (7) P/N D 255 7 2350 006.

(i) Parts Installation Limitation

    As of the effective date of this AD, no person may install, on
the CLS of any airplane, a YZ-latch having a part number listed in
paragraphs (h)(1) through paragraph (h)(7) of this AD, unless it has
been modified in accordance with the requirements of paragraph (h)
of this AD.

(j) Credit for Previous Actions

    (1) This paragraph provides credit for the installation required
by paragraph (g) of this AD, if the installation was performed
before April 12, 2007 (the effective date of AD 2007-05-13,
Amendment 39-14974 (72 FR 10348, March 8, 2007), using Airbus
Service Bulletin A320-25-1294, dated March 14, 2003; or Revision 01,
dated March 27, 2006. Neither service bulletin is incorporated by
reference in this AD.
    (2) This paragraph provides credit for the modification required
by paragraph (h) of this AD, if the modification was performed
before the effective date of this AD using any of the following
service information, and the additional work is done in accordance
with the applicable instructions referenced as ``ADDITIONAL WORK''
in the Accomplishment Instructions of Airbus Mandatory Service
Bulletin A320-25-1294, Revision 06, dated July 23, 2010.
    (i) Airbus Service Bulletin A320-25-1294, dated March 14, 2003.
    (ii) Airbus Service Bulletin A320-25-1294, Revision 01, dated
March 27, 2006.
    (iii) Airbus Service Bulletin A320-25-1294, Revision 02, dated
September 5, 2006.
    (iv) Airbus Mandatory Service Bulletin A320-25-1294, Revision
03, dated January 22, 2007.
    (v) Airbus Mandatory Service Bulletin A320-25-1294, Revision 04,
dated March 13, 2008.
    (vi) Airbus Mandatory Service Bulletin A320-25-1294, Revision
05, dated January 22, 2009.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may
be emailed to<EMAIL_ADDRESS>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 or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(l) Related Information

    (1) Refer to MCAI European Aviation Safety Agency AD 2011-0077,
dated May 5, 2011; and the following service information; for
related information.
    (i) Airbus Mandatory Service Bulletin A320-25-1294, Revision 06,
dated July 23, 2010.
    (ii) Airbus Service Bulletin A320-25-1294, Revision 02, dated
September 5, 2006.
    (2) For service information identified in this AD, contact
Airbus SAS--EIAS (Airworthiness Office), 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email account.airworth-

<EMAIL_ADDRESS>Internet http://www.airbus.com.

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (3) The following service information was approved for IBR on
May 20, 2013.
    (i) Airbus Mandatory Service Bulletin A320-25-1294, Revision 06,
dated July 23, 2010.
    (ii) Reserved.
    (4) The following service information was approved for IBR on of
April 12, 2007 (72 FR 10348, March 8, 2007).
    (i) Airbus Service Bulletin A320-25-1294, Revision 02, dated
September 5, 2006.
    (ii) Reserved.
    (5) For service information identified in this AD, contact
Airbus SAS--EIAS (Airworthiness Office), 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (6) You may review copies of the 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>.
    (7) You may view this service information that is incorporated
by reference 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.

    Issued in Renton, Washington, on March 28, 2013.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-08570 Filed 4-12-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Page 28219]
[FR Doc No: 2017-12843]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Forty Seventh RTCA SC206 Aeronautical Information and
Meteorological Data Link Services Plenary

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

ACTION: Forty Seventh RTCA SC206 Aeronautical Information and
Meteorological Data Link Services Plenary.

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of Forty Seventh RTCA SC206 Aeronautical Information and
Meteorological Data Link Services Plenary.

DATES: The meeting will be held July 10, 2017, 09:30 a.m.-12:00 p.m.

ADDRESSES: The meeting will be held at: RTCA Headquarters, 1150 18th
Street NW., Suite 910, Washington, DC 20036.

FOR FURTHER INFORMATION, CONTACT: Karan Hofmann at<EMAIL_ADDRESS>or
202-330-0680, or The RTCA Secretariat, 1150 18th Street NW., Suite 910,
Washington, DC 20036, or by telephone at<PHONE_NUMBER>, fax at (202)
833-9434, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of the Forty Seventh RTCA SC206 Plenary. The
agenda will include the following:

Monday, May 10, 2017--9:00 a.m.-12:00 p.m.

1. Opening remarks: DFO, RTCA, and Chairman
2. Attendees' introductions
3. Review and approval of meeting agenda
4. Approval of December 2016 meeting minutes (Washington, DC)
5. Action item review
6. Sub-Groups reports
    a. SG1: CSC JC and Other SC Coordination
    b. SG5: FIS-B MOPS
7. Document approval
    a. SG7: Wind Document FRAC Resolution
    b. SG4: EDR Guidelines for FRAC Release
8. TOR Changes
    a. SG4: Document type and title
    b. SG5: Schedule change for new products and scope
9. Adjourn

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on June 15, 2017.
Mohannad Dawoud,
Management & Program Analyst, Partnership Contracts Branch, ANG-A17,
NextGen, Procurement Services Division, Federal Aviation
Administration.
[FR Doc. 2017-12843 Filed 6-19-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 3 (Monday, January 6, 2014)]
[Notices]
[Page 660]
[FR Doc No: 2013-31501]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4158-DR; Docket ID FEMA-2013-0001]

California; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of California (FEMA-4158-DR), dated December 13,
2013, and related determinations.

DATES: Effective Date: December 13, 2013.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated December 13, 2013, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of California resulting from the Rim Fire during the period of
August 17 to October 24, 2013, is of sufficient severity and
magnitude to warrant a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (the ``Stafford Act''). Therefore, I declare that such
a major disaster exists in the State of California.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Stephen M. DeBlasio Sr., of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following area of the State of California has been designated
as adversely affected by this major disaster:

    Tuolumne County for Public Assistance.
    All counties within the State of California are eligible to
apply for assistance under the Hazard Mitigation Grant Program.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-31501 Filed 1-3-14; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: April 14, 2008 (Volume 73, Number 72)]
[Notices]
[Page 20039-20041]
[DOCID:fr14ap08-47]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2007-0035; FRL-8554-1]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Chemical Recovery
Combustion Sources at Kraft, Soda, Sulfite, and Stand-Alone
Semichemical Pulp Mills (Renewal), EPA ICR Number 1805.05, OMB Control
Number 2060-0377

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

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 14, 2008.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2007-0035, 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 2201T, 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: Leonard Lazarus, Compliance Assessment
and Media Programs Division (CAMPD), Office of Compliance, (2223A),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; 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 March 9, 2007 (72 FR 10735), 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-2007-0035, 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 Chemical Recovery Combustion Sources at Kraft,
Soda, Sulfite, and Stand-Alone Semichemical Pulp Mills (Renewal).
    ICR Numbers: EPA ICR Number 1805.05, OMB Control Number 2060-0377.
    ICR Status: This ICR is scheduled to expire on April 30, 2008.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while his 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: Hazardous air pollutant (HAP) emissions from chemical
recovery combustion sources at kraft, soda, sulfite, and stand-alone
semichemical pulp mills cause or contribute to air pollution that may
reasonably be anticipated to endanger public health or welfare.
Therefore, National Emission Standards for Hazardous Air Pollutants
(NESHAP) were promulgated for this source category.
    The control of emissions of HAP from chemical recovery combustion
sources at kraft, soda, sulfite, and stand-alone semichemical pulp
mills requires not only the installation of properly designed
equipment, but also the operation and maintenance of that equipment.
This NESHAP covering emissions from chemical recovery combustion
sources at kraft, soda, sulfite, and stand-alone semichemical pulp
mills relies on the capture and/or reduction of HAP emissions by
recovery furnaces, smelt dissolving tanks (SDTs), lime kilns, or soda
or sulfite combustion units.
    Pulp mill owners or operators (respondents) are required to submit
initial notifications, 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. Respondents are required to monitor and keep records of
specific operating parameters for each control device and to perform
and document periodic inspections of the closed vent and wastewater
conveyance systems. As much as possible, in order to reduce the burden,
the compliance monitoring and recordkeeping requirements are designed
to cover parameters that are already being monitored as part of the
manufacturing process. All respondents must submit semiannual summary
reports of monitored parameters, and they must submit an additional
monitoring report during each quarter in which monitored parameters
were outside the ranges established in the standard or during initial
performance tests. A source identified to be out of compliance with the
NESHAP will be required to submit quarterly reports until the
Administrator is satisfied that the source has corrected its compliance
problem.
    In order to ensure compliance with these standards, adequate
reporting and recordkeeping is necessary. In the absence of such
information, enforcement personnel would be unable to determine whether
the standards are being met on a continuous basis, as required by the
Clean Air Act.
    All reports are sent to the delegated state or local authority. In
the event that there is no such delegated authority, the reports are
sent directly to the EPA regional office. Notifications are used to
inform the Agency or delegated authority when a source becomes subject
to the standard. The reviewing authority may then inspect the source to
check if the pollution control devices are properly installed and
operated. Performance test reports are needed as these are the Agency's
record of a source's initial capability to comply with the emission
standard and note the operating conditions under which compliance was
achieved. The quarterly reports are used for problem identification, as
a check on source operation and maintenance, and for compliance
determinations. The standard also requires semiannual reporting of
deviations from monitored opacity, as this is a good indicator of the
source's compliance status. Responses to this information collection
are mandatory (40 CFR part 63, subpart MM). Any information submitted
to the Agency for which a claim of confidentiality is made will be
safeguarded according to the Agency policies set forth in title 40,
chapter 1, part 2, subpart B--Confidentiality of Business Information
(CBI) (see 40 CFR part 2; 41 FR 36902, September 1, 1976; amended by 43
FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR
17674, March 23, 1979).
    Burden Statement: The annual public reporting and recordkeeping
burden for

this collection of information is estimated to average 475 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: Owners or operators of pulp mills
with chemical recovery combustion sources:
    Estimated Number of Respondents: 130.
    Frequency of Response: Initially, on occasion, quarterly,
semiannually.
    Estimated Total Annual Hour Burden: 150,043 hours.
    Estimated Total Annual Cost: $8,667,298, which includes capital/
startup costs of $123,000, O&M costs of $864,000, and $7,680,298 in
labor costs.
    Changes in the Estimates: There is no change in the labor hours or
cost 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, so there is no significant change in the overall
burden.
    Since there are no changes in the regulatory requirements and there
is no significant industry growth, the labor hours and cost figures in
the previous ICR are used in this ICR and there is no change in burden
to industry.

    Dated: April 7, 2008.
Sara Hisel-McCoy,
Director, Collection Strategies Division.
[FR Doc. E8-7873 Filed 4-11-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Page 36510]
[FR Doc No: 2014-15077]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER14-2187-001]

Grand Ridge Energy Storage LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Grand Ridge Energy Storage LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
Part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability, is July 14, 2014.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 23, 2014.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2014-15077 Filed 6-26-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 190 (Friday, September 30, 2011)]
[Notices]
[Pages 60850-60851]
[FR Doc No: 2011-25173]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3334-EM; Docket ID FEMA-2011-0001]

Rhode Island; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of an

emergency for the State of Rhode Island (FEMA-3334-EM), dated August
27, 2011, and related determinations.

DATES: Effective Date: August 27, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 27, 2011, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5208 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in the State of
Rhode Island resulting from Hurricane Irene beginning on August 26,
2011, and continuing, are of sufficient severity and magnitude to
warrant an emergency declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(``the Stafford Act''). Therefore, I declare that such an emergency
exists in the State of Rhode Island.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), including direct Federal assistance, under the Public
Assistance program. This assistance excludes regular time costs for
subgrantees' regular employees.
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Gracia
B. Szczech, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared emergency.
    The following areas of the State of Rhode Island have been
designated as adversely affected by this declared emergency:

    Providence, Kent, Washington, Newport, and Bristol Counties for
emergency protective measures (Category B), including direct federal
assistance, under the Public Assistance program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-25173 Filed 9-29-11; 8:45 am]
BILLING CODE 9111-23-P