[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Notices]
[Pages 1074-1075]
[FR Doc No: 2023-00013]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0545]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Biological Products:
Reporting of Biological Product Deviations and Human Cells, Tissues,
and Cellular and Tissue-Based Product Deviations in Manufacturing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by February 6, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0458. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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

Cellular and Tissue-Based Product Deviations in Manufacturing; Forms
FDA 3486 and 3486A

OMB Control Number 0910-0458--Extension

    Under section 351 of the Public Health Service Act (PHS Act) (42
U.S.C. 262), all biological products, including human blood and blood
components, offered for sale in interstate commerce must be licensed
and meet standards, including those prescribed in FDA regulations,
designed to ensure the continued safety, purity, and potency of such
products. In addition, under section 361 of the PHS Act (42 U.S.C.
264), FDA may issue and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases between
the States or possessions or from foreign countries into the States or
possessions. Further, the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 351) provides that drugs and devices (including human
blood and blood components) are adulterated if they do not conform with
current good manufacturing practice (CGMP) assuring that they meet the
requirements of the FD&C Act. Establishments manufacturing biological
products, including human blood and blood components, must comply with
the applicable CGMP regulations (parts 211, 606, and 820 (21 CFR parts
211, 606, and 820)) and current good tissue practice (CGTP) regulations
(part 1271 (21 CFR part 1271)) as appropriate. FDA regards biological
product deviation (BPD) reporting and human cells, tissues, and
cellular and tissue-based product (HCT/P) deviation reporting to be an
essential tool in its directive to protect public health by
establishing and maintaining surveillance programs that provide timely
and useful information.
    Section 600.14 (21 CFR 600.14), in brief, requires the manufacturer
who holds the biological product license, for other than human blood
and blood components, and who had control over a distributed product
when the deviation occurred, to report to the Center for Biologics
Evaluation and Research (CBER) or to the Center for Drug Evaluation and
Research (CDER) as soon as possible but at a date not to exceed 45
calendar days after acquiring information reasonably suggesting that a
reportable event has occurred. Section 606.171 (21 CFR 606.171), in
brief, requires licensed manufacturers of human blood and blood
components, including Source Plasma, unlicensed registered blood
establishments, and transfusion services, who had control over a
distributed product when the deviation occurred, to report to CBER as
soon as possible but at a date not to exceed 45 calendar days after
acquiring information reasonably suggesting that a reportable event has
occurred. Similarly, Sec.  1271.350(b) (21 CFR 1271.350(b)), in brief,
requires HCT/P establishments that manufacture non-

reproductive HCT/Ps described in Sec.  1271.10 (21 CFR 1271.10) to
investigate and report to CBER all HCT/P deviations relating to a
distributed HCT/P that relates to the core CGTP requirements, if the
deviation occurred in the establishment's facility or in a facility
that performed a manufacturing step for the establishment under
contract, agreement or other arrangement. Form FDA 3486 is used to
submit BPD reports and HCT/P deviation reports.
    Respondents to this collection of information are: (1) licensed
manufacturers of biological products other than human blood and blood
components, (2) licensed manufacturers of blood and blood components
including Source Plasma, (3) unlicensed registered blood
establishments, (4) transfusion services, and (5) establishments that
manufacture non-reproductive HCT/Ps regulated solely under section 361
of the PHS Act as described in Sec.  1271.10. The number of respondents
and total annual responses are based on the BPD reports and HCT/P
deviation reports FDA received in fiscal year (FY) 2021. The number of
licensed manufacturers and total annual responses under Sec.  600.14
include the estimates for BPD reports submitted to both CBER and CDER.
Based on the information from industry, the estimated average time to
complete a deviation report is 2 hours, which includes a minimal one-
time burden to create a user account for those reports submitted
electronically. The availability of the standardized report form, Form
FDA 3486, and the ability to submit this report electronically to CBER
(CDER does not currently accept electronic filings) further streamlines
the report submission process.
    CBER has developed a web-based addendum to Form FDA 3486 (Form FDA
3486A) to provide additional information when a BPD report has been
reviewed by FDA and evaluated as a possible recall. The additional
information requested includes information not contained in the Form
FDA 3486 such as: (1) distribution pattern; (2) method of consignee
notification; (3) consignee(s) of products for further manufacture; (4)
additional product information; (5) updated product disposition; and
(6) industry recall contacts. This information is requested by CBER
through email notification to the submitter of the BPD report. This
information is used by CBER for recall classification purposes. CBER
estimates that 3 percent of the total BPD reports submitted to CBER
would need additional information submitted in the addendum. CBER
further estimates that it would take between 10 and 20 minutes to
complete the addendum. For calculation purposes, CBER is using 15
minutes.
    Activities such as investigating, changing standard operating
procedures or processes, and followup are currently required under
parts 211 (approved under OMB control number 0910-0139), 606 (approved
under OMB control number 0910-0116), 820 (approved under OMB control
number 0910-0073), and 1271 (approved under OMB control number 0910-
0543) and, therefore, are not included in the burden calculation for
the separate requirement of submitting a deviation report to FDA.
    In the Federal Register of June 17, 2022 (87 FR 36512), we
published a 60-day notice soliciting comment on the proposed collection
of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Number of       Total
           21 CFR section; activity              FDA form     Number of     responses per    annual          Average burden per response         Total
                                                   No.       respondents     respondent     responses                                            hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
600.14; Reporting of product deviations by           3486             103           6.864         707  2.....................................      1,414
 licensed manufacturers.
606.171; Reporting of product deviations by          3486           2,008           6.883      13,821  2.....................................     27,642
 licensed manufacturers, unlicensed registered
 blood establishments, and transfusion
 services.
1271.350(b); HCT/P deviations.................       3486              80           2.575         206  2.....................................        412
Web-based Addendum............................  \2\ 3486A              66            6.69         442  0.25 (15 minutes).....................      110.5
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  .........  ..............  ..............      15,176  ......................................   29,578.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Three percent of the number of respondents ((2,008 + 103 + 80) x 0.03 = 66) and total annual responses to CBER ((13,821 + 707 + 206) x 0.03 = 442).

    Our estimated burden for the information collection reflects an
overall decrease of approximately 65,014 hours and a corresponding
decrease of 34,152 responses. We attribute this adjustment to a
decrease in the number of deviation reports we received in FY 2021 from
licensed manufacturers and unlicensed registered blood establishments
under Sec.  606.171. This is likely due to our issuance of the revised
guidance document entitled ``Biological Product Deviation Reporting for
Blood and Plasma Establishments'' (85 FR 14682, March 13, 2020), which
provided blood and plasma establishments with revised recommendations
related to BPD reporting. The revised guidance provided a less
burdensome policy for reporting BPDs that is consistent with public
health and eliminated the reporting of post donation information (PDI)
events as BPD reports because these reports were no longer unexpected
or unforeseeable. Given the substantial number of PDI reports FDA has
received, the Agency is aware that these events occur, and the
submission of additional PDI reports to FDA is unlikely to facilitate
the identification of manufacturing or safety issues.

    Dated: January 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00013 Filed 1-5-23; 8:45 am]
BILLING CODE 4164-01-P


Mo	0.07	0.24	0.25	0.26	0.18	0.18	0.18	0.35	0.34	0.33	0.35	0.23	0.23	0.24 0.24

Ni	0.01	0.66	0.49	0.58	0.30	0.48	0.14	0.46	0.65	0.62	0.65	0.38	0.47	0.73 0.28

P	171.06	3.25	2.49	2.57	1.81	3.07	1.81	3.54	3.44	4.18	3.52	2.43	2.34 2.75	2.40

K	0.19	3.13	2.86	2.70	1.81	4.52	2.08	3.18	4.99	12.22	3.70	3.24	2.69	4.66 2.76

Se	0.24	0.84	3.23	2.83	0.63	2.26	0.63	1.24	1.29	2.68	1.66	0.81	0.82	0.84 1.15

Ag	0.01	0.02	0.04	0.09	0.05	0.05	0.03	0.07	0.07	0.13	0.07	0.06	0.04	0.10 0.07

Sr	0.19	0.26	0.35	0.40	0.31	0.56	0.26	0.51	1.31	0.80	0.39	0.38	0.36	0.73 1.32

Te	0.17	0.60	0.62	0.64	0.45	0.45	0.45	0.88	0.86	0.84	0.88	0.58	0.59	0.60 0.60

Tl	0.24	0.84	0.87	0.90	0.63	0.63	0.63	1.24	1.21	1.17	1.23	0.81	0.82	0.84 0.84

Sn	0.34	1.20	1.24	1.29	0.90	0.90	0.90	1.77	1.72	21.76	1.76	1.16	1.17 1.20	1.20

Ti	0.03	0.24	0.30	0.49	0.25	0.42	0.22	0.41	0.93	0.75	0.41	0.37	0.41	0.55 0.83

V	0.01	0.04	0.04	0.04	0.03	0.03	0.03	0.05	0.05	0.05	0.07	0.03	0.04	0.04 0.04

Y	0.00	0.01	0.01	0.03	0.03	0.03	0.02	0.07	0.07	0.40	0.11	0.05	0.02	0.04 0.05

Zn	0.07	4.81	7.09	11.33	3.70	5.33	2.35	6.54	8.61	10.88	11.10	8.67	8.67 10.05	4.08

Zr	0.14	0.48	0.50	0.51	0.36	0.36	0.36	0.71	0.69	0.74	1.76	0.46	0.47	0.48 0.48

Appendix D

Metallic Composition of Filter Samples

Concentrations are in g/m3

Sample ID	E2CMTR-01	E2CMTR-02	E2CMTT-01	E2CHTT-02	E2CMTT-03	E2CMWT-01 E2CMWT-02	E2CMWT-03	E2CMWT-04	E2CMWT-05	E2CMWR-01	E2CHWR-02

Date	12/11/07	12/11/07	12/11/07	12/11/07	12/11/07	12/12/07	12/12/07 12/12/07	12/12/07	12/12/07	12/12/07	12/12/07

Al	<0.86	<0.84	<1.26	<1.18	<1.17	<1.42	<1.51	<1.39	<1.41	<1.44	<1.04 <1.02

Sb	<0.34	<0.34	<0.50	<0.47	<0.47	<0.57	<0.60	<0.56	<0.56	<0.58	<0.42 <0.41

As	<0.60	<0.59	<0.88	<0.83	<0.82	<0.99	<1.05	<0.97	<0.98	<1.01	<0.73 <0.71

Ba	0.15	0.22	1.02	1.66	0.08	0.08	0.99	1.03	0.04	0.82	0.05	0.11

Be	<0.02	<0.02	<0.03	<0.02	<0.02	<0.03	<0.03	<0.03	<0.03	<0.03	<0.02 <0.02

Cd	<0.03	<0.03	0.65	0.98	<0.05	<0.06	<0.06	0.64	<0.06	0.45	<0.04	<0.04

Ca	5.13	3.29	10.67	14.21	15.27	14.06	16.57	23.67	5.34	18.74	3.23	4.58

Cr	<0.17	<0.17	0.34	<0.24	<0.23	<0.28	<0.30	<0.28	<0.28	<0.29	<0.21 <0.20

Co	<0.04	<0.04	<0.06	<0.06	<0.06	<0.07	<0.08	<0.07	<0.07	<0.07	<0.05 <0.05

Cu	0.04	0.08	0.19	0.20	0.11	0.18	0.18	0.35	0.11	0.19	<0.03	0.05

Fe	<1.71	<1.68	6.53	11.84	4.93	10.79	18.07	16.71	2.95	6.92	<2.09	<2.04

La	<0.009	<0.008	<0.013	<0.012	<0.012	<0.014	<0.015	<0.014	<0.014	<0.014 <0.010	<0.010

Pb	0.31	0.29	3.26	8.17	<0.23	<0.28	0.31	0.31	<0.28	0.31	<0.21	<0.20

Li	<0.009	<0.008	<0.013	<0.012	<0.012	<0.014	<0.015	<0.014	<0.014	<0.014 <0.010	<0.010

Mg	0.28	0.16	0.67	1.11	0.80	0.50	0.66	1.39	0.31	0.88	<0.10	<0.10

Mn	<0.04	0.05	0.09	0.40	0.11	0.12	0.18	0.24	<0.07	0.14	<0.05	<0.05

Mo	<0.26	<0.25	<0.38	<0.36	<0.35	<0.43	<0.45	<0.42	<0.42	<0.43	<0.31 <0.31

Ni	0.02	<0.08	0.13	0.17	0.15	0.11	0.15	0.21	<0.14	<0.14	<0.10	<0.10

P	<0.86	<0.84	<1.26	<1.18	<1.17	<1.42	<1.51	<1.39	<1.41	<1.44	<1.04 <1.02

K	0.27	0.26	1.23	2.01	0.56	<0.43	1.01	2.09	<0.42	1.44	<0.31	<0.31

Se	<2.57	<2.53	<3.77	<3.55	<3.52	<4.26	<4.52	<4.18	<4.22	<4.32	<3.13 <3.06

Ag	<0.009	<0.008	<0.013	<0.012	<0.012	<0.014	<0.015	<0.014	<0.014	<0.014 <0.010	<0.010

Sr	0.06	0.07	0.41	0.50	0.04	0.31	0.30	0.56	0.34	0.58	0.01	0.05

Te	<0.34	<0.34	<0.50	<0.47	0.05	<0.57	<0.60	<0.56	0.47	0.83	<0.42	<0.41

Tl	<0.43	<0.42	<0.63	<0.59	<0.59	<0.71	<0.75	<0.70	<0.70	<0.72	<0.52 <0.51

Sn	<0.60	<0.59	<0.88	<0.83	<0.82	<0.99	1.08	<0.97	<0.98	<1.01	<0.73 <0.71

Ti	0.02	<0.01	0.05	0.08	0.07	0.18	0.11	0.18	0.18	0.12	<0.01	<0.01

V	<0.02	<0.02	<0.03	<0.02	<0.02	<0.03	<0.03	<0.03	<0.03	<0.03	<0.02 <0.02

Y	0.33	0.75	40.18	59.22	0.27	0.33	28.62	20.89	<0.03	25.94	0.16	0.35

Zn	1.0	1.8	63.9	65.0	1.4	2.0	39.0	38.8	0.8	43.1	0.4	1.1

Zr	<0.09	<0.08	<0.13	<0.12	<0.12	<0.14	<0.15	<0.14	<0.14	<0.14	<0.10 <0.10

Appendix D (Continued)

Sample ID	E2CMWR-03	E2CMWR-04	E2CMWR-05	E2CMWT-06	E2CMWR-06	E2CMHT-01 E2CMHT-02	E2CMHT-03	E2CMHR-02	E2CMHR-03	E2CMHR-04

Date	12/12/07	12/12/07	12/12/07	12/12/07	12/12/07	12/13/07	12/13/07 12/13/07	12/13/07	12/13/07	12/13/07

Al	<1.03	<1.01	<1.04	<1.36	<0.58	<0.78	2.98	5.80	<0.54	<1.09	<1.06

Sb	<0.41	<0.40	<0.42	<0.54	<0.23	<0.31	<0.63	<0.59	<0.22	<0.44	<0.42

As	<0.72	<0.70	<0.73	<0.95	<0.41	<0.54	<1.10	<1.04	<0.38	<0.77	<0.74

Ba	0.04	<0.02	<0.02	0.35	<0.01	0.31	2.19	3.42	0.25	0.37	0.53

Be	<0.02	<0.02	<0.02	<0.03	<0.01	<0.02	<0.02	<0.03	<0.01	<0.02	<0.02

Cd	<0.04	<0.04	<0.04	<0.05	<0.02	0.37	7.83	12.93	0.08	<0.04	0.11

Ca	3.40	2.71	3.13	62.45	0.64	4.51	25.07	38.63	3.81	4.81	6.22

Cr	<0.21	<0.20	<0.21	<0.27	<0.12	<0.16	0.38	0.43	<0.11	<0.22	<0.21

Co	<0.05	<0.05	<0.05	<0.07	<0.03	<0.04	<0.08	<0.07	<0.03	<0.05	<0.05

Cu	0.10	0.43	0.20	1.29	0.06	0.06	0.33	0.48	0.13	0.11	0.19

Fe	<2.06	<2.01	<2.09	10.05	<1.16	2.18	12.85	26.75	1.63	<2.19	<2.11

La	<0.010	<0.010	<0.010	<0.014	<0.006	<0.008	<0.016	0.030	<0.005	<0.011 <0.011

Pb	<0.21	<0.20	<0.21	0.31	<0.12	0.31	0.31	0.31	0.31	0.31	0.31

Li	<0.010	<0.010	<0.010	<0.014	<0.006	<0.008	<0.016	<0.015	<0.005	<0.011 <0.011

Mg	<0.10	<0.10	<0.10	1.63	<0.06	0.18	1.44	2.38	0.27	0.13	0.27

Mn	<0.05	0.71	0.20	0.26	<0.03	<0.04	0.33	0.56	0.14	<0.05	<0.05

Mo	<0.31	<0.30	<0.31	<0.41	<0.17	<0.23	<0.47	<0.45	<0.16	<0.33	<0.32

Ni	<0.10	<0.10	0.06	0.15	0.01	0.12	0.08	0.31	0.02	<0.11	0.07

P	<1.03	<1.00	<1.04	<1.36	<0.58	<0.78	<1.57	49.04	<0.54	<1.09	4.64

K	<0.31	<0.30	<0.31	1.00	<0.17	0.64	4.70	5.50	0.87	0.51	1.16

Se	<3.09	<3.01	<3.13	<4.07	<1.74	<2.33	<4.70	<4.46	<1.63	<3.28	<3.17

Ag	<0.010	<0.010	<0.010	<0.014	<0.006	<0.008	<0.016	<0.015	<0.005	<0.011 <0.011

Sr	0.08	<0.01	1.25	0.90	0.70	0.16	1.02	1.63	1.03	0.12	0.24

Te	<0.41	<0.40	1.31	<0.54	<0.23	<0.31	<0.63	<0.59	<0.22	<0.44	<0.42

Tl	<0.52	<0.50	<0.52	<0.68	<0.29	<0.39	<0.78	<0.74	<0.27	<0.55	<0.53

Sn	<0.72	<0.70	<0.73	<0.95	<0.41	<0.54	<1.10	<1.04	<0.38	<0.77	<0.74

Ti	0.05	<0.01	0.56	0.50	<0.01	0.03	0.15	0.28	0.50	<0.01	0.02

V	<0.02	<0.02	<0.02	<0.03	<0.01	<0.02	<0.03	<0.03	<0.01	<0.02	<0.02

Y	0.39	<0.02	<0.02	0.09	<0.01	7.70	104.96	178.31	2.34	1.86	3.27

Zn	1.0	0.1	0.4	4.1	0.0	17.8	234.8	386.2	6.5	5.4	9.0

Zr	<0.10	<0.10	<0.10	<0.14	<0.06	<0.08	<0.16	<0.15	<0.05	<0.11	<0.11

Figure I	Diagram of the Unicor factory located within the FCI main compound

(See Figure IV for more detail of Glass Breaking Operation)

Figure II 	Diagram of the Unicor facility in the Federal Satellite Low (FSL)

Figure III	Diagram of the warehouse handling electronics recycling operations

Figure IV	Diagram of the glass breaking area within the FCI

Figure V – Elkton Warehouse Showing Storage Areas with Boxes of Items to be Recycled

Figure VI – Overview of Elkton Recycling Factory Disassembly Area

Figure VII – Electron Gun Removal in Glass Breaking Operation

Figure VIII – Filter Change Operation in Glass Breaking Area

 Showing Large Amount of Visible Dust

Figure X – Three cut particle size distribution from impactor data

 This report documents the study conducted at Elkton, Ohio.  Other NIOSH field studies were conducted at Federal correctional facilities in Lewisburg, Pennsylvania and Marianna, Florida

 On March 20, 1991, the Supreme Court decided the case of International Union, United Automobile, Aerospace & Agricultural Implement Workers of America, UAW v. Johnson Controls, Inc., 111 S. Ct. 1196, 55 EPD 40,605.  It held that Title VII forbids sex-specific fetal protection policies.  Both men and women must be protected equally by the employer.

 OSHA PELs, unless otherwise noted, are TWA concentrations that must not be exceeded during any 8-hour workshift of a 40-hour work-week [NIOSH 1997].  NIOSH RELs, unless otherwise noted, are TWA concentrations for up to a 10-hour workday during a 40-hour workweek [NIOSH 1997].  ACGIH® TLVs®, unless otherwise noted, are TWA concentrations for a conventional 8-hour workday and 40-hour workweek [ACGIH 2008]

 71 minutes at 92.5 dBA/318 minutes allowed at 93 dBA + 179 minutes at 97.7 dBA/156 minutes allowed at 98 dBA = 1.37, or 137% of the allowable dose.

 67 min at 90.5dbA/420 minutes allowed at 91 dBA + 181 minutes at 93.4 dBA/318 minutes allowed at 93 dBA = 0.73, or 73% of allowable dose; and 102 minutes at 91.6 dBA/306 minutes allowed at 92 dBA +  177 minutes at 91 dBA/420 minutes allowed at 91 dBA = 0.75, or 75% of the allowable dose.

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 PAGE   51

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 PAGE   59


[Federal Register Volume 75, Number 10 (Friday, January 15, 2010)]
[Notices]
[Pages 2537-2538]
[FR Doc No: 2010-731]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2009-0378; FRL-9103-5]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Area Sources:
Polyvinyl Chloride and Copolymer Production, Primary Copper Smelting,
Secondary Copper Smelting, and Primary Nonferrous Metals--Zinc,
Cadmium, and Beryllium (Renewal); EPA ICR Number 2240.03, OMB Control
Number 2060-0596

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 February 16,
2010.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2009-0378, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
28221T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2)
OMB at: Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th
Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Compliance Assessment
and Media Programs Division, Office of Compliance, Mail Code 2223A,
Environmental Protection Agency, 1200 Pennsylvania Avenue, 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 July 8, 2009 (74 FR 32580), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to EPA and OMB within 30 days
of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2009-0378, 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 Area Sources: Polyvinyl Chloride and Copolymer
Production, Primary Copper Smelting, Secondary Copper Smelting, and
Primary Nonferrous Metals--Zinc, Cadmium, and Beryllium (Renewal).
    ICR Numbers: EPA ICR Number 2240.03, OMB Control Number 2060-0596.
    ICR Status: This ICR is schedule to expire on January 31, 2010.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, and displayed either by
publication in

the Federal Register or by other appropriate means, such as on the
related collection instrument or form, if applicable. The display of
OMB control numbers in certain EPA regulations is consolidated in 40
CFR part 9.
    Abstract: NESHAP for Area Sources: Polyvinyl Chloride and Copolymer
Production, Primary Copper Smelting, Secondary Copper Smelting, and
Primary Nonferrous Metals--Zinc, Cadmium, and Beryllium (Renewal), were
proposed on October 16, 2006, and promulgated on January 23, 2007.
These regulations apply to any new and existing primary copper smelter,
a new secondary copper smelter, a new or existing primary zinc
production facility or a primary beryllium production facility that is
an area source of hazardous air pollutant (HAP) emissions. An affected
source is existing, if they commenced construction or reconstruction
before October 6, 2006, and a new source if they commenced construction
or reconstruction on or after October 6, 2006.
    Owners and operators of a new and existing area source is subject
to the General Provision (40 CFR part 63, subpart A). An existing
affected source is required to submit an initial notification of
applicability and a notification of compliance status. They are also
required to certify initial compliance with particulate matter (PM)
limits based on previous performance test results. These notifications,
reports, and records are essential in determining compliance, and are
required of all affected facilities subject to NESHAP.
    Any owner or operator subject to the provisions of this subpart
must maintain a file of these measurements, and retain the file for at
least five years following the collection of such measurements,
maintenance reports, and records.
    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. This information is being
collected to assure compliance with 40 CFR part 63, subpart EEEEEE; 40
CFR part 63, subpart FFFFFF; 40 CFR part 63, subpart DDDDDD; 40 CFR
part 63, subpart GGGGGG; 40 CFR part 61, subpart F; 40 CFR part 61,
subpart C; as authorized in sections 112 and 114(a) of the Clean Air
Act. The required information consists of emissions data and other
information that has been determined to be private.
    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 Number for EPA
regulations listed in 40 CFR part 9 and 48 CFR chapter 15, are
identified on the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information estimated to average 12 hour
per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose and 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. All
existing ways will have to adjust to comply with any previously
applicable instructions and requirements that 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: Polyvinyl Chloride and Copolymer
Production, Primary Copper Smelting, Secondary Copper Smelting, and
Primary Nonferrous Metals--Zinc, Cadmium, and Beryllium.
    Estimated Number of Respondents: 5.
    Frequency of Response: Initially.
    Estimated Total Annual Hour Burden: 46.
    Estimated Total Annual Cost: $4,326, which includes $4,326 in labor
costs, no capital/startup costs, and no operation and maintenance (O&M)
costs.
    Changes in the Estimates: In this ICR, we have accounted for all
five sources as compared to the previous ICR. There are no new sources
and are not anticipated to change over the next three year; the growth
rate for the industry is very low, negative or nonexistent, thus, there
is no significant change in the overall number of sources. A change in
the cost burden was due to an increase in the hourly labor rates.

    Dated: January 6, 2010.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2010-731 Filed 1-14-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 111 (Monday, June 10, 2013)]
[Rules and Regulations]
[Pages 34558-34559]
[FR Doc No: 2013-13360]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-1237; Airspace Docket No. 12-AWP-9]

Modification of Class E Airspace; Clifton/Morenci, AZ

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action modifies Class E airspace at Greenlee County
Airport, Clifton/Morenci, AZ, to accommodate aircraft using Area
Navigation (RNAV) Global Positioning System (GPS) standard instrument
approach procedures at Greenlee County Airport. This improves the
safety and management of Instrument Flight Rules (IFR) operations at
the airport.

DATES: Effective date, 0901 UTC, August 22, 2013. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA, 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On March 26, 2013, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to modify controlled airspace at
Clifton/Morenci, AZ (78 FR 18269). Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received.
    Class E airspace designations are published in paragraph 6005, of
FAA Order 7400.9W dated August 8, 2012, and effective September 15,
2012, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by modifying Class E airspace extending upward from 700 feet
above the surface at Greenlee County Airport, Clifton/Morenci, AZ.
Additional controlled airspace extending upward from 1,200 feet above
the surface at Greenlee County Airport is necessary to accommodate IFR
aircraft executing RNAV (GPS) standard instrument approach procedures
at the airport. This action is necessary for the safety and management
of IFR operations.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
only affects air traffic procedures and air navigation, it is certified
this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act. The FAA's authority to issue rules
regarding aviation safety is found in Title 49 of the U.S. Code.
Subtitle 1, Section 106 discusses the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it modifies
controlled airspace at Greenlee County Airport, Clifton/Morenci, AZ.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9W, Airspace Designations and
Reporting Points, dated August 8, 2012, and effective September 15,
2012 is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AWP AZ E5 Clifton/Morenci, AZ [Modified]

Greenlee County Airport, AZ
    (Lat. 32[deg]57'25'' N., long. 109[deg]12'40' W.)

    That airspace extending from 700 feet above the surface within a
6.5-mile radius of Greenlee County Airport; that airspace extending
upward from 1,200 feet above the surface within an area bounded by a
line beginning at lat. 33[deg]09'00'' N., long. 109[deg]51'00'' W.;
to lat. 33[deg]07'00'' N., long. 108[deg]47'00'' W.; to lat.
32[deg]27'00'' N., long. 108[deg]15'00'' W.; to lat. 32[deg]17'00''
N., long. 108[deg]38'00'' W.; to lat. 32[deg]18'00'' N., long.
109[deg]31'00'' W.; thence to the point of beginning.

    Issued in Seattle, Washington, on May 24, 2013.
Clark Desing,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2013-13360 Filed 6-7-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 213 (Monday, November 4, 2013)]
[Notices]
[Pages 66010-66011]
[FR Doc No: 2013-26119]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1204]

Draft Risk Profile on Pathogens and Filth in Spices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft risk profile entitled ``FDA Draft Risk Profile:
Pathogens and Filth in Spices'' (draft risk profile). Our main
objectives were to: Describe the nature and extent of the public health
risk posed by consumption of spices in the United States by identifying
the most commonly occurring microbial hazards and filth in spice;
describe and evaluate current mitigation and control options designed
to reduce the public health risk posed by consumption of contaminated
spices in the United States; identify potential additional mitigation
or control options designed to reduce the public health risk posed by
the consumption of contaminated spices in the United States; and
identify data gaps and research needs. The draft risk profile is
intended to provide information for FDA risk managers to use in
regulatory decision making related to the safety of spices in the U.S.
food supply. The information may also be useful to stakeholders and
interested parties such as spice producers and importers, spice and
food manufacturers, retail food establishments, and consumers.

DATES: Submit either electronic or written comments on the draft risk
profile by January 3, 2014.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments on the draft risk profile to Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jane Van Doren, Center for Food Safety
and Applied Nutrition (HFS-005), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In response to recent outbreaks in the United States of human
illness associated with consumption of certain spices, as well as other
reports in the literature and within FDA suggesting that current
pathogen control measures in spices may not adequately protect public
health, we developed a draft risk profile on pathogens and filth in
spices (Ref. 1). We initiated the draft risk profile in response to a
large outbreak of Salmonella Rissen infections in 2008 to 2009
associated with the consumption of ground white pepper in the United
States (id.). Subsequently, in 2009 to 2010, the United States had a
larger outbreak of Salmonella Montevideo infections associated with
consumption of products containing black and red pepper (id.). The
objectives of the draft risk profile are to: (1) Describe the nature
and extent of the public health risk posed by consumption of spices in
the United States by identifying the most commonly occurring microbial
hazards and filth in spice; (2) describe and evaluate current
mitigation and control options designed to reduce the public health
risk posed by consumption of contaminated spices in the United States;
(3) identify potential additional mitigation and control options; and
(4) identify data gaps and research needs.
    Specific risk management questions that are addressed include:
     What is known about the frequency and levels of pathogen
and/or filth contamination of spices throughout the food supply chain
(e.g., on the farm, at primary processing/manufacturing, at
intermediary processing (where spices are used as ingredients in multi-
component products), at distribution (including importation), at retail
sale/use, and at the consumer's home)?
     What is known about the differences in production and
contamination of imported and domestic spices?
     What is known about the effectiveness and practicality of
currently available and potential future mitigations and control
options to prevent human illnesses associated with contaminated spices
(e.g., practices and/or technologies to reduce or prevent
contamination, surveillance, inspection, import strategies, or
guidance)?
     What are the highest priority research needs related to
prevention or reduction of contamination of spices with pathogens or
filth?
    The draft risk profile has undergone an independent external peer
review, and our response to the peer review is available electronically
on the FDA Web site (Ref. 2).
    For the purpose of the draft risk profile, we consider ``spice'' to
mean any dried aromatic vegetable substances in the whole, broken, or
ground form,

except for those substances which have been traditionally regarded as
foods, whose significant function in food is seasoning rather than
nutritional, and from which no portion of any volatile oil or other
flavoring principle has been removed. We also consider dehydrated onion
and garlic and other dehydrated vegetables used as seasoning to be
spices.
    The specific microbial hazards and filth in spices that we consider
in the draft risk profile include those pathogen and filth adulterants
detected in spices, implicated in outbreaks, reported as the reason for
recalls, and reported in submissions to the Reportable Food Registry
(RFR) (Ref. 3). The draft risk profile focuses on Salmonella, among the
pathogens detected in spices, because it is the only spice-associated
pathogen linked with human illness, food recalls, and RFR reports in
the United States.
    We invite comments that can help improve: (1) The data and
information used; (2) the analytical analyses employed; and (3) the
clarity and the transparency of the draft risk profile.

II. Comments

    Interested persons may submit either electronic comments regarding
the draft risk profile to http://www.regulations.gov or written
comments to the Division of Dockets Management (see ADDRESSES). It is
only necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the draft risk
profile at either (http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM367337.pdf) or http://www.regulations.gov.

IV. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m. Monday through Friday, and
are available electronically at http://www.regulations.gov. (We have
verified the Web site addresses in this reference section, but we are
not responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.)

1. U.S. Food and Drug Administration (2013). ``FDA Draft Risk
Profile: Pathogens and Filth in Spices.'' Accessible at http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM367337.pdf.
2. U.S. Food and Drug Administration (2013). ``FDA Draft Risk
Profile: Pathogens and Filth in Spices: Peer Review Report: External
Peer Review Comments and FDA Responses.'' Accessible at http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM367338.pdf.
3. U.S. Food and Drug Administration (2013). Reportable Food
Registry Annual Report. Accessible at http://www.fda.gov/Food/ComplianceEnforcement/RFR/default.htm.

    Dated: October 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26119 Filed 10-30-13; 4:15 pm]
BILLING CODE 4160-01-P


[Federal Register: April 4, 2007 (Volume 72, Number 64)]
[Notices]
[Page 16343-16344]
[DOCID:fr04ap07-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 11351-014]

Columbia Power & Water Systems; Notice of Availability of
Environmental Assessment

March 29, 2007.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission (Commission or FERC)
regulations contained in the Code of Federal Regulations (CFR) (18 CFR
Part 380) [FERC Order No. 486, 52 FR 47897], the Office of Energy
Project's staff (staff) reviewed a proposal to surrender the license
for the Old Columbia Dam Project, and prepared an environmental
assessment (EA) for this proposed surrender. In this EA, staff
evaluates potential effects of the proposed surrender and finds that
there would be no effects to aquatic or terrestrial resources,
threatened or endangered species, recreation resources, or land use.
The Commission also determined that the proposed surrender may
adversely affect properties listed in the National Register due to the
loss of Federal jurisdiction, and executed a Memorandum of Agreement
(MOA) with the Tennessee State Historic Preservation Officer, pursuant
to 36 CFR part 800.3 and 36 CFR part 800.6 of the Advisory Council on
Historic Preservation regulations implementing Section 106 of the
National Historic Preservation Act (16

U.S.C. 470f), in order to mitigate the adverse effects of the proposed
surrender. The EA concludes that the proposed action will not
constitute a major federal action significantly affecting the human
environment.
    A copy of the EA is attached to Commission order titled ``Order
Approving Surrender of License'', issued March 28, 2007 and is
available for review at the Commission in the Public Reference Room,
located at 888 First Street, NE., Room 2A, Washington, DC 20426, or may
be viewed on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, call toll-free 1-866-209-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-6206 Filed 4-3-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: January 30, 2009 (Volume 74, Number 19)]
[Notices]
[Page 5692-5694]
[DOCID:fr30ja09-102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59298; File No. SR-DTC-2008-15]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing and Order Granting Accelerated Approval of a Proposed
Rule Change To Provide The Options Clearing Corporation With Settlement
Services for Stock Loan Transactions Entered Into Under the Market Loan
Program

January 26, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on December 23, 2008, The
Depository Trust Company (``DTC'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change as
described in Items I and II below, which items have been prepared
primarily by DTC. The Commission is publishing this notice and order to
solicit comments on the proposed rule change and to grant accelerated
approval of the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

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

    DTC is seeking to provide settlement services for stock loan
transactions entered into under The Options Clearing Corporation's
(``OCC'') proposed Market Loan Program.\2\
---------------------------------------------------------------------------

    \2\ OCC filed a proposed rule change (File No. SR-OCC-2008-20)
with the Commission that is being approved simultaneously with this
proposed rule change to describe proposed changes in its rules for
purposes of establishing the Market Loan Program.
---------------------------------------------------------------------------

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

    In its filing with the Commission, DTC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. DTC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\3\
---------------------------------------------------------------------------

    \3\ The Commission has modified the text of the summaries
prepared by DTC.
---------------------------------------------------------------------------

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

    OCC has approached DTC seeking DTC's settlement services for its
proposed Market Loan Program in which OCC will act as a central
counterparty for stock loan transactions. Under the proposal, OCC will
submit stock loan deliver orders to DTC on a locked-in basis on behalf
of the parties to the transactions. OCC will open a new account at DTC
for this service.
    Under OCC's proposed Market Loan Program, a stock loan is initiated
when a lender is matched with a borrower through an electronic platform
that supports securities lending and borrowing transactions by matching
lenders and borrowers based on loan terms that each party is willing to
accept. Once matched, the electronic platform will send details of the
matched stock loan transaction to OCC. If the matched transaction
passes OCC's validation process, OCC will create and send to DTC a pair
of delivery orders, one message instructing DTC to transfer a specified
number of shares of a specified eligible stock from the lending
Participant to OCC's account and the

other message instructing DTC to transfer the same number of shares of
the same stock with the same dollar value from OCC's account to the
borrowing Participant's account. Each participant that elects to use
the proposed Market Loan Program will authorize DTC by written
agreement to accept instructions on its behalf from OCC, requesting
that DTC debit or credit the Participant's DTC account with regard to
said stock loan transactions.\4\
---------------------------------------------------------------------------

    \4\ The debit or credit will depend on whether the Participant
is the borrower or the lender in the stock loan transaction. DTC
Participants that wish to use this service will also be required to
acknowledge that reclaims to OCC under $15 million will not override
OCC's net debit cap and will recycle until OCC submits a redelivery
to the lender or until the reclaim drops at the recycle cutoff.
---------------------------------------------------------------------------

    Since OCC's Market Loan Program is intended to be primarily an
anonymous market, OCC will establish a new account at DTC for this
activity.\5\ The transfer of securities for value between the lender
and the borrower will pass through the new OCC account in order to
enable the stock loan transaction to be settled in a manner that
provides anonymity to both the lender and borrower. In an effort to
ensure that OCC's stock loan transactions complete, DTC is proposing to
bypass the collateral monitor in OCC account.\6\ This will advance
transactions from the collateral recycle queue to the net debit cap
recycle queue and will allow look-ahead to capture the transactions.
DTC will also set the net debit cap \7\ on OCC's account to zero so
that all receives into the account recycle for net debit cap. A zero
net debit cap will ensure that no receives are completed to OCC account
unless an offsetting delivery is also completed.
---------------------------------------------------------------------------

    \5\ A new Participant-level master file indicator will be used
to signify that both Participants, the borrower and lender, have
agreed to use the service.
    \6\ DTC's Account Transaction Processor (``ATP'') is the core
processing system for all transaction activity affecting security
positions held at DTC. It checks receiver's collateral before it
checks for debit cap. If DTC did not bypass the collateral monitor
then the deliveries into OCC account would pend for collateral first
and would not be processed by look-ahead.
    \7\ Before completing a transaction in which a Participant is
the receiver, DTC calculates the resulting effect the transaction
would have on such Participant's account, and determines whether the
resulting net balance would exceed the Participant's net debit cap.
Any transaction that would cause the net settlement debit to exceed
the net debit cap is placed on a pending (recycling) queue until
another transaction creates credits in such Participant's account.
---------------------------------------------------------------------------

    In order to reduce the possibility of mismatched stock loans, DTC
is proposing to amend its current look-ahead process for OCC stock loan
transactions so that look-ahead matches on number of shares and dollar
amount in addition to CUSIP. The existing Look-Ahead process finds
delivery transactions that are pending because the receiving
Participant has reached its net debit cap. It then looks to see whether
the receiving Participant has a pending delivery for the same security
to another Participant. In such a situation, DTC's Account Transaction
Processor (``ATP'') will calculate the net effect to the collateral and
net debit cap controls for all three Participants involved. If the net
effect will not result in a deficit in the collateral or net debit cap
controls for any of the three Participants, ATP processes the
transactions simultaneously.
    Additionally, DTC is proposing to block matched reclaims into OCC's
account. Participants will be permitted to reclaim \8\ to OCC's
account, but reclaims under $15 million will not override OCC's debit
cap and will recycle until OCC submits a redelivery back to the lender
or until the reclaim drops at the recycle cutoff.\9\ Under DTC's
existing procedures, if the borrowing Participant reclaimed to OCC and
the reclaim was less than $15 million, the reclaim would override the
DTC Risk Management controls for OCC's account creating a debit in
OCC's account. The debit would be eliminated if OCC entered a reclaim
to the lending Participant.
---------------------------------------------------------------------------

    \8\ A ``reclaim'' is an instruction to DTC to undo a delivery
and is typically invoked in the event of an error where a
Participant does not recognize the delivery.
    \9\ If OCC does not submit a redelivery to the lender, then the
borrower's reclaim to OCC will drop at the recycle cutoff (i.e., the
borrower will retain the securities and the debit for the stock loan
delivery it received from OCC). This is how DTC currently treats
reclaims that are over $15 million.
---------------------------------------------------------------------------

    DTC believes that the proposed rule change is consistent with the
requirements of Section 17A of the Act \10\ and the rules and
regulations thereunder applicable to DTC because it should promote the
prompt and accurate clearance and settlement of stock loan transactions
which would settle through the Look-Ahead process and achieve a more
efficient level of straight-through processing.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

(B) Self-Regulatory Organization's Statement on Burden on Competition

    DTC does not believe that the proposed rule change would have any
impact or impose any burden on competition.

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

    Written comments relating to the proposed rule change have not been
solicited or received. DTC will notify the Commission if it receives
additional comments.

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

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder and particularly with the requirements of Section
17A(b)(3)(F).\11\ Section 17A(b)(3)(F) requires that the rules of a
clearing agency be designed to promote the prompt and accurate
clearance and settlement of securities transactions and, in general, to
protect investors and the public interest. The Commission finds that
the approval of DTC's rule change is consistent with this section
because it will allow DTC to provide to OCC settlement of stock loan
transactions which will settle through the Look-Ahead process and will
achieve a more efficient level of straight-through processing.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    DTC has requested that the Commission approve the proposed rule
change prior to the thirtieth day after publication of the notice of
the filing. The Commission finds good cause for approving the proposed
rule change prior to the thirtieth day after the publication of notice
because such approval will allow DTC to implement the proposed rule
change by the end of January 2009 when OCC plans to commence its
proposed Market Loan Program in which OCC will act as a central
counterparty for stock loan transactions.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-DTC-2008-15 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-DTC-2008-15. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of DTC and on DTC's Web
site at http://www.dtcc.com/downloads/legal/rule_filings/2008/dtc/
2008-15.pdf. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-DTC-
2008-15 and should be submitted on or before February 20, 2009.
    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\12\ that the proposed rule change (File No. SR-DTC-2008-15) be and
hereby is approved.\13\
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(2).
    \13\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).
    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-1983 Filed 1-29-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: April 30, 2008 (Volume 73, Number 84)]
[Notices]
[Page 23457-23459]
[DOCID:fr30ap08-84]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0263; FRL-8363-5]

Fenvalerate; Notice of Receipt of Requests to Voluntarily Cancel
Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a
notice of receipt of requests by the registrants to voluntarily cancel
the registrations for all of their products containing 4-chloro-alpha-
(1-methylethyl)benzeneacetic acid, cyano(3-phenoxyphenyl)methyl ester
(fenvalerate). The requests would terminate the last fenvalerate
products registered for use in the United States. EPA intends to grant
these requests at the close of the comment period for this announcement
unless the Agency receives substantive comments within the comment
period that would merit its further review of the requests, or unless
the registrants withdraw their requests within this period. Upon
acceptance of these requests, any sale, distribution, or use of
products listed in this notice will be permitted only if such sale,
distribution, or use is consistent with the terms as described in the
final order.

DATES: Comments must be received on or before May 30, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0263, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2008-0263. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Wilhelmena Livingston, Special Review
and Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address: livingston.wilhelmena @epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not

contain the information claimed as CBI must be submitted for inclusion
in the public docket. Information so marked will not be disclosed
except in accordance with procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background on the Receipt of Requests to Cancel Registrations

    This notice announces receipt by EPA of requests from Waterbury
Companies, Inc., Contact Industries, The Scotts Company, Phaeton
Corporation, and Amrep Inc. to cancel 16 product registrations.
Fenvalerate is a synthetic pyrethroid insecticide which is used to
control insects and related organisms, mollusks, fouling organisms and
miscellaneous invertebrates on agricultural, pet care, domestic home
and garden (domestic), and commercial/industrial/food and non-food/
mosquito abatement (commercial) sites. In letters dated August 29, 2007
through April 2, 2008, Waterbury Companies, Inc., Contact Industries,
The Scotts Company, Phaeton Corporation, and Amrep, Inc. requested EPA
to cancel affected product registrations of pesticide product
registrations identified in this notice in Table 1. Specifically, the
registrant's requests to cancel their product registrations to reflect
the cancellation order issued on August 5, 2004 (69 FR 47437) (FRL-
7369-9), as requested by the technical registrants, Sumitomo Chemical
Company, Limited and Bayer Environmental Science and approved by the
Agency to cancel the registrations for all of their product containing
fenvalerate. The action on the registrant's requests will terminate the
last fenvalerate products registered in the United States.
    In a letter dated August 1, 2007, another registrant, Wellmark
International, submitted a request to EPA to voluntary cancel their
product registrations containing fenvalerate. The notice of receipt of
request for their product registrations was published in a Federal
Register Notice on December 19, 2007 (72 FR 71898) (FRL-8343-9).

III. What Action is the Agency Taking?

    This notice announces receipt by EPA of requests from registrants
to cancel fenvalerate product registrations. The affected products and
the registrants making the requests are identified in Tables 1 and 2 of
this unit.
    Under section 6(f)(1)(A) of FIFRA, registrants may request, at any
time, that their pesticide registrations be canceled or amended to
terminate one or more pesticide uses. Section 6(f)(1)(B) of FIFRA
requires that before acting on a request for voluntary cancellation,
EPA must provide a 30-day public comment period on the request for
voluntary cancellation or use termination. In addition, section
6(f)(1)(C) of FIFRA requires that EPA provide a 180-day comment period
on a request for voluntary cancellation or termination of any minor
agricultural use before granting the request, unless:
    1. The registrants request a waiver of the comment period, or
    2. The Administrator determines that continued use of the pesticide
would pose an unreasonable adverse effect on the environment.
     The fenvalerate registrants have requested that EPA waive the 180-
day comment period. EPA will provide a 30-day comment period on the
proposed requests.
     Unless a request is withdrawn by a registrant within 30 days of
publication of this notice, or if the Agency determines that there are
substantive comments that warrant further review of this request, an
order will be issued canceling the affected registrations.

  Table 1.--Fenvalerate Product Registrations with Pending Requests for
                              Cancellation
------------------------------------------------------------------------
       Registration Number           Product Name           Company
------------------------------------------------------------------------
538-166                           Scotts House Plant  The Scotts Company
                                   Insect Spray
------------------------------------------------------------------------
538-173                           Chinch Bug Control  The Scotts Company
------------------------------------------------------------------------
9444-120                          Total Release       Waterbury
                                   Fogger              Companies, Inc.
------------------------------------------------------------------------
10806-61                          Contact Roach and   Contact Industries
                                   Ant Killer VI
------------------------------------------------------------------------
10806-73                          Contact Lawn Spray  Contact Industries
                                   Concentrate for
                                   Fleas
------------------------------------------------------------------------
10806-74                          Contact Lawn Spray  Contact Industries
                                   Concentrate for
                                   Fleas II
10806-87                          Contact Roach and   Contact Industries
                                   Ant Killer IX
------------------------------------------------------------------------
10806-93                          Contact Ornamental  Contact Industries
                                   Gypsy Moth and
                                   Japanese Beetle
                                   Spray
------------------------------------------------------------------------
10806-94                          Contact Roach and   Contact Industries
                                   Ant Killer XI
------------------------------------------------------------------------
10807-150                         Misty Fire Ant      Amrep, Inc.
                                   Injector
------------------------------------------------------------------------
28293-151                         Unicorn Flea and    Phaeton
                                   Tick Lawn Spray     Corporation
                                   No.1
------------------------------------------------------------------------

28293-159                         Unicorn RTU Home    Phaeton
                                   and Premise Spray   Corporation
------------------------------------------------------------------------
28293-162                         Unicorn Zap         Phaeton
                                   Insecticide         Corporation
------------------------------------------------------------------------
28293-163                         Unicorn Flush-Out   Phaeton
                                   Spray               Corporation
------------------------------------------------------------------------
28293-164                         Unicorn Household   Phaeton
                                   Insecticide II      Corporation
------------------------------------------------------------------------
28293-217                         Unicorn Residual    Phaeton
                                   Spray 4    Corporation
------------------------------------------------------------------------

    Table 2 of this unit includes the names and addresses of record for
the registrants of the products listed in Table 1 of this unit.

         Table 2 --Registrants Requesting Voluntary Cancellation
------------------------------------------------------------------------
            EPA Company Number                Company Name and Address
------------------------------------------------------------------------
538                                         The Scotts Company
                                            14111 Scottslawn Road
                                            Marysville, Ohio 43041
------------------------------------------------------------------------
9444                                        Waterbury Companies, Inc.
                                            64 Avenue of Industry
                                            Waterbury, Connecticut 06705
------------------------------------------------------------------------
10806                                       Contact Industries
                                            641 Dowd Avenue
                                            Elizabeth, NJ 07201
------------------------------------------------------------------------
10807                                       Amrep, Inc.
                                            990 Industrial Park Drive
                                            Marietta, Georgia 30062
------------------------------------------------------------------------
28293                                       Phaeton Corporation
                                            P.O. Box 290
                                            Madison, Georgia 30650
------------------------------------------------------------------------

IV. What is the Agency's Authority for Taking this Action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register. Thereafter,
following the public comment period, the Administrator may approve such
a request.

V. Procedures for Withdrawal of Request and Considerations for
Reregistration of Fenvalerate

    Registrants who choose to withdraw a request for cancellation must
submit such withdrawal in writing to the person listed under FOR
FURTHER INFORMATION CONTACT, postmarked May 30, 2008. This written
withdrawal of the request for cancellation will apply only to the
applicable FIFRA section 6(f)(1) request listed in this notice. If the
products have been subject to a previous cancellation action, the
effective date of cancellation and all other provisions of any earlier
cancellation action are controlling.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action.
    In any order issued in response to the request for cancellation of
product registrations, EPA proposes to include the following provisions
for the treatment of any existing stocks of the products identified or
referenced in Table 1 of Unit III.: Registrants may sell and distribute
existing stocks for 1 year from the date of the use termination
request. The products may be sold, distributed, and used by people
other than the registrant until existing stocks have been exhausted,
provided that such sale, distribution, and use complies with the EPA-
approved label and labeling of the product.
    If the request for voluntary cancellation is granted, the Agency
intends to publish the cancellation order in the Federal Register.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: April 24, 2008.
 Steven Bradbury,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E8-9511 Filed 4-29-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 78, Number 141 (Tuesday, July 23, 2013)]
[Proposed Rules]
[Pages 44050-44052]
[FR Doc No: 2013-17632]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0634; Directorate Identifier 2012-SW-023-AD]
RIN 2120-AA64

Airworthiness Directives; Eurocopter Deutschland GmbH Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Eurocopter Deutschland GmbH (Eurocopter) Model EC135P2+ and
EC135T2+ helicopters. This proposed AD would require inspecting the
mechanical air conditioning system compressor bearing block upper
bearing (upper bearing) for corrosion, leaking grease, condensation, or
water. This proposed AD is prompted by metallic debris from an upper
bearing found in the air inlet areas of both engines in a Model
EC135P2+ helicopter. The proposed actions are intended to prevent
metallic debris from damaging the engine, causing loss of engine power,
and subsequent loss of helicopter control.

DATES: We must receive comments on this proposed AD by September 23,
2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the foreign
authority's AD, the economic 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.
    For service information identified in this proposed AD, contact
American Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>;
or at http://www.eurocopter.com/techpub. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas
76137.

FOR FURTHER INFORMATION CONTACT: Matt Wilbanks, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
No. 2011-0111R1, dated September 22, 2011, which revises EASA AD No.
2011-0111, dated June 10, 2011, to correct an unsafe condition for
certain Model EC135P2+ and EC135T2+ helicopters. EASA

advises that metallic debris was found within the air inlet area of
both engines during a pre-flight check of an EC135 P2+ helicopter. A
subsequent investigation showed that the debris came from the bearing
cage of a ball bearing in the air conditioning compressor bearing
block, and it damaged the compressor stage of one of the engines to
such an extent that the engine had to be overhauled, according to EASA.
    EASA notes that as this mechanical air conditioning system was
introduced recently on the production line, only a limited number of
helicopters are affected. But if not detected and corrected, this
unsafe condition ``could lead to further cases of bearing case failure,
possibly resulting in loss of engine power and reduced control of the
helicopter,'' EASA reports. EASA AD No. 2011-0111R1 requires repetitive
inspections of the affected ball bearing for indications that the upper
bearing is failing and, depending on the findings, deactivating the air
conditioning system.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Germany and are approved for operation in the United States. Pursuant
to our bilateral agreement with Germany, EASA, its technical
representative, has notified us of the unsafe condition described in
its AD. We are proposing this AD because we evaluated all known
relevant information and determined that an unsafe condition is likely
to exist or develop on other products of the same type design.

Related Service Information

    Eurocopter issued Emergency Alert Service Bulletin (EASB) EC 135-
21A-013, Revision 0, dated June 6, 2011, to provide instructions for
inspections after debris from the bearing cage of a ball bearing was
found in the air inlet area of both engines of an EC135P2+ helicopter.
Eurocopter followed the EASB with Service Bulletin (SB) EC 135-21-015,
Revision 0, dated July 12, 2011, to introduce the replacement of the
affected compressor bearing block with a ``new, improved'' compressor
bearing block.

Proposed AD Requirements

    This proposed AD would require, within 25 hours time-in-service
(TIS), visually inspecting the upper bearing for corrosion, leaking
grease, condensation or water--indications that the upper bearing is
failing. If only condensation exists, the proposed AD would require
repeating the inspection at intervals not to exceed 25 hours TIS. If
none of those conditions exists, the proposed AD would require
repeating the inspection at intervals not to exceed 100 hours TIS. If
there is water, corrosion, or leaking grease, this proposed AD would
require deactivating the air conditioning system.

Costs of Compliance

    We estimate that this proposed AD would affect 1 helicopter of U.S.
Registry and that labor costs would average $85 per work-hour. Based on
these estimates, we expect the following costs:
     Inspecting the upper bearing for corrosion, leaking
grease, condensation or water would require 4 work-hours for a labor
cost of $340. No parts would be needed.
     Deactivating the air conditioning system would require 6
work-hours for a labor cost of $510. No parts would be needed.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; 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 an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Eurocopter Deutschland GmbH Helicopters: Docket No. FAA-2013-0634;
Directorate Identifier 2012-SW-023-AD.

(a) Applicability

    This AD applies to Model EC135P2+ and EC135T2+ helicopters,
serial numbers 870, 872, 873, 879, 883, 884, 888, 893, 900, 905,
911, 914, 916, 917, 923, and 926, with a mechanical air conditioning
system compressor bearing block upper bearing (upper bearing) part
number L210M1872105 installed, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as metallic debris in the
engine inlet areas. This condition could result in failure of an
engine, loss of engine power, and subsequent loss of helicopter
control.

(c) Comments Due Date.

    We must receive comments by September 23, 2013.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless accomplished
previously.

(e) Required Actions

    Within 25 hours time-in-service (TIS):
    (1) Visually inspect the upper bearing for corrosion, leaking
grease, condensation, or water.
    (2) If there is condensation but no corrosion, leaking grease,
or water, repeat

this inspection at intervals not to exceed 25 hours TIS.
    (3) If there is no corrosion, leaking grease, condensation, or
water, repeat this inspection at intervals not to exceed 100 hours
TIS.
    (4) If there is corrosion, leaking grease, or water, deactivate
the air conditioning system in accordance with the Accomplishment
Instructions, Section 3.B.3, Paragraphs (a) through (ai) of
Eurocopter Emergency Alert Service Bulletin No. EC 135-21A-013,
dated June 6, 2011.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Matt Wilbanks, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, Texas 76137; telephone (817) 222-
5110; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD No. 2011-0111R1, dated September 22, 2011. You may
view a copy of the EASA AD in the AD Docket on the Internet at
http://www.regulations.gov.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 2100, air
conditioning system.

    Issued in Fort Worth, Texas, on July 11, 2013.
Kim Smith,
Directorate Manager, Rotorcraft Directorate, Aircraft Certification
Service.
[FR Doc. 2013-17632 Filed 7-22-13; 8:45 am]
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