[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)]
[Notices]
[Pages 52292-52293]
[FR Doc No: 2017-24455]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER14-2046-004.
    Applicants: Plum Point Energy Associates, LLC.
    Description: Compliance filing: Informational Filing Pursuant to

Schedule 2 of the MISO OATT to be effective N/A.
    Filed Date: 11/6/17.
    Accession Number: 20171106-5196.
    Comments Due: 5 p.m. ET 11/27/17.

    Docket Numbers: ER16-2217-005.
    Applicants: Logan Generating Company, L.P.
    Description: Compliance filing: Information Filing Pursuant to
Schedule 2 of the PJM OATT to be effective N/A.
    Filed Date: 11/6/17.
    Accession Number: 20171106-5204.
    Comments Due: 5 p.m. ET 11/27/17.

    Docket Numbers: ER17-2515-001.
    Applicants: Chambers Cogeneration, Limited Partnership.
    Description: Compliance filing: Informational Filing Pursuant to
Schedule 2 of the PJM OATT to be effective N/A.
    Filed Date: 11/6/17.
    Accession Number: 20171106-5200.
    Comments Due: 5 p.m. ET 11/27/17.

    Docket Numbers: ER18-252-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Rev to OA, Sched 1, sec
6.4.1 and OATT, Att K-Appx, sec 6.4.1 RE: Offer Capping to be effective
1/3/2018.
    Filed Date: 11/3/17.
    Accession Number: 20171103-5217.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER18-253-000.
    Applicants: Duke Energy Progress, LLC.
    Description: Sec.  205(d) Rate Filing: DEP-French Broad EMC RS Nos.
195 & 210 to be effective 1/1/2016.
    Filed Date: 11/3/17.
    Accession Number: 20171103-5231.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER18-254-000.
    Applicants: PJM Interconnection, L.L.C., Buckeye Power, Inc.
    Description: Sec.  205(d) Rate Filing: Revised SA No. 4753--NITSA
among PJM and Buckeye Power, Inc. to be effective 1/1/2018.
    Filed Date: 11/6/17.
    Accession Number: 20171106-5302.
    Comments Due: 5 p.m. ET 11/27/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 6, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-24455 Filed 11-9-17; 8:45 am]
 BILLING CODE 6717-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Memorandum SUBJECT: Responses to Questions Concerning Disulfoton Posed by Special Review and Reregistration Division FROM: Colwell A. Co ok, Entom ologist Nikhil Mallampalli, Entomologist Herbicide and Insecticide Branch Anthony Gilbert, Eco nomist Economic Analysis Branch Biological and Economic Analysis Division THROUGH: David Brassard, Senior Entomologist Arnet Jones, Chief Herbicide and Insecticide Branch Biological and Economic Analysis Division Arthur Grube, Senior Economist Economic Analysis Branch Biological and Economic Analysis Division BEAD PEER REVIEW DATE: 12 December 2001 TO: Christina Scheltema Michael Goodis Betty Shackleford, Chief Special Review and Reregistration Division CC: Denise Keehner, Director, OPP/ BEAD Introduction A meeting was held on November 28, 2001 between Special Review and Reregistration Division (SRRD) and BEAD concerning disulfoton. This memo addresses questions posed by SRRD during the meeting. The questions ranged from general information to help SR RD complete the IRED to verifying concerns from growers. This memo contains p roprietary d ata and is for O PP use o nly.

Questions And Answers 1. The Pacific Northwest (PNW) primarily uses the liquid formulation of disulfoton on potatoes. Is the granular product needed for use outside the PNW?

Granular disulfoton (15G), like the liquid (8EC), is used at a relatively low level nationwide. However, more crop area (nationwide) is treated with granular than with liquid, according to Doane s data. In 2000, about 11,000 acres were treated with 15G, 8,000 with 8EC. This is equivalent to about 1% of the 2000 crop treated with 15G, as compared to about 0.6 % treated with 8EC. Some extension services still list granular disulfoton as a pest control option, which is presumably followed by growers in their regions. These include: Texas, North Dakota, New York, Delaware, and Colorado  all states outside the PNW. Taken together, these results suggest greater reliance on granular disulfoton in potato production outside the PNW. However, since granular disulfoton is used on less than 2% of the national potato crop, its use may reasonably be characterized as somewhat low.

2. There was an SLN in 1992 for North Carolina peanuts. Where is disulfoton on peanuts used? What are the formulations an d the target pests?

Only the granular formulation of disulfoton is registered for use on peanuts. There is a Section 3 label for nationwide use on this crop. However, North Carolina has a 24( c) label that allows two applications per season instead of the sin gle applica tion allowed elsewhere. T hrips are the m ain targeted p est, though in so me areas (e .g., Texas), aphids are also listed as targets (USDA Crop Profile) of peanuts. The main thrips species involved is the tobacco thrips, Frankliniella fusca. Doane's data indicate usage in peanuts in the following states in 2000: Alabama, Georgia, North Carolina, and Oklahoma.

3. Is it reasonable to narrow the scope of the 15G label to gladiolus in Florida, deciduous (birch) trees in New England and New York state? Ho w narrowly ca n EPA define the use of disulfoton o n ornamentals?

Unknown. The ornamental industry is quite varied, not only because there are well over 600 species of plants grown commercially, but there is little common practice among nursery and floriculture producers. We do know that of the 4,000 operations that responded to the NASS survey for Nursery and Floriculture Chemical Usage (to be published Dec. 2001 or Jan. 2002), only 22 operations reported using disulfoton on a total of 56 applications (about 0.1% of reported pesticide ap plications). W ith such low rep orting NA SS will prob ably not con duct much analyses with this chemical.

BEAD has not been able to verify the Am erican Nu rsery and La ndscape Association  s claim that disulfo ton is critical to the indu stry and rate red uctions belo w 13 lbs ai/ A will cause significan t harm to the nu rsery industry. Based o n NASS information sta ted abov e, disulfoton d oes not ap pear to be critical to the indu stry. The Ca lifornia Department of Pesticide Regulation (CA DPR, years 1997 1999) database does not have any record of use above 6 lbs ai/ A. There are a couple of growers of birch trees in NY that do use disulfoton at the 13 lbs ai/ A rate, but they offered no evidence why such a rate is necessary. At this time, BEAD believes the critical need of disulfoton to be low.

4. How much disulfoton is used on lettuce and co le crops in California, spe cifically the Salinas Valley, vs. the rest of the country? Where and how much of the granular formulation of disulfoton is used for cole crops and peppers? If there is no use of the granular, does it make sense to cancel?

The table below examines the amount of disulfoton that has been used on the selected vegetables in CA. Salinas Valley encompasses Monterey, San Benito, Santa Clara and Santa Cruz Counties. Since Monterey County is the largest prod uction area it is the subject of the table.

Site Pounds of Disulfoton applied to the Site in CA (3 yr Average: 1997 1999) 1 % of the CA Disulfoton used by Site in Monterey Co., CA Broccoli 8617 60 Brussels Sprouts 394 87 Cabbage 2 3117 <1 Cauliflower 1114 52 Lettuce, head 8883 59 Lettuce, leaf 2377 57 1 Data from the CA DPR database and includes years 1997 1999. 2 Ventura Co, not part of Salinas Valley, is maximum user of disulfoton in CA, 3 yr average of 83% of disulfoton applied to cabbage.

Also, from the CA D PR database (years 1997 199 9), an average of 85,6 17 lbs of disulfoton was app lied to 36 crops, about 29% of which was applied in Salinas Valley. The majority of disulfoton was applied to asparagus (about 45%), of which less than 10% is gr own in Salina s Valley, CA .

USDA NASS Agriculture Chemical Usage Vegetable Summary 2000 has limited information. The low number of reports of d isulfoton are p robably b ecause the u sage is low on vegetable c rops othe r than aspara gus. Broccoli Production: CA, AZ, TX; with 6% of CA broccoli treated with disulfoton (7,200 lbs). Cabbage Production: CA, NY , TX, NC; with all states reporting some use. Only 3% of total cabbage produced was treate d with a total of 3 ,400 lbs d isulfoton nation wide. Cauliflower Production: CA, AZ, NY; no reported use in AZ or NY. Lettuce Production: CA, AZ; no reported use in AZ. Bell Peppers: CA, FL, NC, GA; no reported use in FL, NC, or GA.

About 85 87% of disulfoton is applied as the liquid formulation on asparagus, broccoli, cabbage, cauliflower, lettuce, and peppers, both nationally and in California. If EPA cancels the granular formulation of disulfoton on these crop s the smaller gro wers would bear the ec onomic impact, either b y investing in new a pplication e quipment, by hiring com mercial ap plicators, or n ot growing the crop.


[Federal Register Volume 85, Number 196 (Thursday, October 8, 2020)]
[Notices]
[Pages 63648-63649]
[FR Doc No: 2020-22312]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2020-0178]

Agency Information Collection Activities; Renewal of a Currently-
Approved Information Collection Request: Financial Responsibility for
Motor Carriers of Passengers and Motor Carriers of Property

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval and invites public comment. The information
collected will be used to help ensure that motor carriers of passengers
and property maintain appropriate levels of financial responsibility to
operate on public highways.

DATES: We must receive your comments on or before December 7, 2020.

ADDRESSES: You may submit comments identified by Federal Docket
Management System (FDMS) Docket Number FMCSA-2020-0178 using any of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.

     Hand Delivery or Courier: U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001 between 9 a.m. and 5 p.m. e.t.,
Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the agency name and
docket number. For detailed instructions on submitting comments, see
the Public Participation heading below. Note that all comments received
will be posted without change to http://www.regulations.gov, including
any personal information provided. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov, and follow the
online instructions for accessing the dockets, or go to the street
address listed above.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.
    Public Participation: The Federal eRulemaking Portal is available
24 hours each day, 365 days each year. You can obtain electronic
submission and retrieval help and guidelines under the ``help'' section
of the Federal eRulemaking Portal website. If you want us to notify you
that we received your comments, please include a self-addressed,
stamped envelope or postcard, or print the acknowledgement page that
appears after submitting comments online. Comments received after the
comment closing date will be included in the docket and will be
considered to the extent practicable.

FOR FURTHER INFORMATION CONTACT: Mr. Jeff Secrist, Office of
Registration and Safety Information, Chief, Registration, Licensing and
Insurance Division, Department of Transportation, Federal Motor Carrier
Safety Administration, West Building 6th Floor, 1200 New Jersey Avenue
SE, Washington, DC 20590. Telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Background: The Secretary of Transportation is responsible for
implementing regulations which establish minimum levels of financial
responsibility for: (1) For-hire motor carriers of property to cover
public liability, property damage, and environmental restoration, and
(2) for-hire motor carriers of passengers to cover public liability and
property damage. The Endorsement for Motor Carrier Policies of
Insurance for Public Liability (Forms MCS-90/90B) and the Motor Carrier
Public Liability Surety Bond (Forms MCS-82/82B) contain the minimum
amount of information necessary to document that a motor carrier of
property or passengers has obtained, and has in effect, the minimum
levels of financial responsibility as set forth in applicable
regulations (49 CFR 387.9 (motor carriers of property) and 49 CFR
387.33T (motor carriers of passengers)). FMCSA and the public can
verify that a motor carrier of property or passengers has obtained, and
has in effect, the required minimum levels of financial responsibility
by reviewing the information enclosed within these documents.
    Title: Financial Responsibility for Motor Carrier of Passengers and
Motor Carriers of Property.
    OMB Control Number: 2126-0008.
    Type of Request: Renewal of a currently-approved information
collection.
    Respondents: Insurance underwriters for insurance companies and
financial specialists for surety companies of motor carriers of
property (Forms MCS-90 and MCS-82) and passengers (Forms MCS-90B and
MCS-82B), and motor carrier compliance officers employed by motor
carriers to store and maintain insurance and/or surety bond
documentation in motor carrier vehicles.
    Estimated Number of Respondents: 466,328.
    Estimated Time per Response: FMCSA estimates that it takes 2
minutes to complete the Endorsement for Motor Carrier Policies of
Insurance for Public Liability (Forms MCS-90 for property carriers and
MCS-90B for passenger carriers) or the Motor Carrier Public Liability
Surety Bond (Forms MCS-82 for property carriers and MCS-82B for
passenger carriers); 1 minute to store/maintain documents at the motor
carrier's principal place of business [49 CFR 387.7(d); 49 CFR
387.31(d)]; and 1 minute per vehicle to place the respective document
on board the vehicle as required for non U.S.-domiciled carriers [49
CFR 387.7(f); 49 CFR 387.31(f)].
    Expiration Date: March 31, 2021.
    Frequency of Response: Upon creation, change, or replacement of an
insurance policy or surety bond. Approximately one time per year.
    Estimated Total Annual Burden: 13,214 hours.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the performance of FMCSA's functions; (2)
the accuracy of the estimated burden; (3) ways for the FMCSA to enhance
the quality, usefulness, and clarity of the collected information; and
(4) ways that the burden could be minimized without reducing the
quality of the collected information. The agency will summarize or
include your comments in the request for OMB's clearance of this
information collection.

Thomas Keane,
Associate Administrator, Office of Research and Registration.
[FR Doc. 2020-22312 Filed 10-7-20; 8:45 am]
BILLING CODE 4910-EX-P


72168 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Notices and approval. Any comments related to the renewal of this ICR should be submitted within 30 days of this notice, as described above.

Dated: November 22, 2002. Oscar Morales, Director, Collection Strategies Division, Office of Environmental Information. [ FR Doc. 02   30761 Filed 12   3   02; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OEI   2002   0003; FRL   7417   3]

Agency Information Collection Activities; Submission of EPA ICR No. 1363.12 ( OMB No. 2070   0093) to OMB for Review and Approval; Comment Request; Toxic Chemical Release Reporting AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( PRA) ( 44 U. S. C. 3501 et seq.), this notice announces that the Information Collection Request ( ICR) ( EPA ICR No. 1363.12; OMB Control No. 2070   0093) for the Toxics Release Inventory ( TRI) Form R has been forwarded to the Office of Management and Budget ( OMB) for review and approval pursuant to the OMB procedures in 5 CFR 1320.12. The ICR, which is summarized below, describes the nature of the information collection and its estimated burden and cost, and it includes the actual data collection instrument where appropriate. The Agency is requesting that OMB renew for three years the existing approval for this ICR, which is scheduled to expire on January 31, 2003. A Federal Register notice announcing the Agency's intent to seek the renewal of this ICR and the 60 day public comment opportunity, requesting comments on the request and the contents of the ICR, was issued on July 1, 2002 ( 67 FR 44213). A Federal Register correction notice, correcting the address for submission of comments in person, was issued on July 15, 2002 ( 67 FR 46502). EPA received a number of comments on this ICR during the comment period, and EPA has developed responses to those comments. The comments and EPA's responses are included in an attachment to the ICR Supporting Statement that is being submitted to OMB with this ICR renewal request, and will be made available in the docket for OEI   2002   0003 and on the EPA TRI Web site at http:// www. epa. gov/ tri. DATES: Additional comments may be submitted on or before January 3, 2003. FOR FURTHER INFORMATION CONTACT: Judith Kendall, TRI Program Division, Office of Environmental Information, Mailcode 2844, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 202) 566   0750; email address: kendall. judith@ epa. gov; fax number: ( 202) 566   0741. ADDRESSES: Follow the detailed instructions in SUPPLEMENTARY INFORMATION.

SUPPLEMENTARY INFORMATION: Review Requested: This is a request to renew a currently approved information collection pursuant to 5 CFR 1320.12. ICR Numbers: EPA ICR 1363.12; OMB Control No. 2070   0093. Current Expiration Date: Current OMB approval expires on January 31, 2003. EPA has established a public docket for this ICR under Docket ID No. OEI   2002   0003, which is available for public viewing at the OEI Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., 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 ( 202) 566   1744, and the telephone number for the OEI Docket is ( 202) 566   1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e mail to oei. docket@ epa. gov or by mail to: EPA Docket Center, Environmental Protection Agency, Mailcode: 2844, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) Mail your comments to 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. EPA's policy is those public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov/ edocket. Title: Toxic Chemical Release Reporting, Recordkeeping, Supplier Notification and Petitions under Section 313 of the Emergency Planning and Community Right to Know Act ( EPCRA). Background: EPCRA section 313 requires owners and operators of certain facilities that manufacture, process, or otherwise use any of the more than 650 listed toxic chemicals and chemical categories in excess of applicable threshold quantities to report annually to the Environmental Protection Agency and to the states in which such facilities are located on their environmental releases and other waste management quantities of such chemicals. In addition, section 6607 of the Pollution Prevention Act ( PPA) requires that facilities provide information on the quantities of the toxic chemicals in waste streams and the efforts made to reduce or eliminate those quantities. Annual reporting of toxic chemical releases and other waste management information under EPCRA section 313 provides citizens with a more complete picture of the total disposition of chemicals in their communities and helps focus industries' attention on pollution prevention and source reduction opportunities. EPA believes that the public has a right to know about the disposition of chemicals within communities and the management of such chemicals by facilities in industries subject to EPCRA section 313 reporting. This reporting has been successful in providing communities with important information regarding VerDate 0ct< 31> 2002 19: 04 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 04DEN1. SGM 04DEN1 72169 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Notices the disposition of toxic chemicals and other waste management information of toxic chemicals from manufacturing facilities in their areas. EPA collects, processes, and makes available to the public all of the information collected. The information gathered under these authorities is stored in a database maintained at EPA and is available through the Internet. This information, commonly known as the Toxics Release Inventory ( TRI), is used extensively by both EPA and the public sector. Program offices within EPA use TRI data, along with other sources of data, to establish priorities, evaluate potential exposure scenarios, and undertake enforcement activities. Environmental and public interest groups use the data in studies and reports, making the public more aware of releases of chemicals in their communities. Comprehensive publicly available data about releases, transfers, and other waste management activities of toxic chemicals at the community level are generally not available, other than under the reporting requirements of EPCRA section 313. Permit data are often difficult to obtain, are not cross media and present only a limited perspective on a facility's overall performance. With TRI data, and the real gains in understanding it has produced, communities and governments know what toxic chemicals are released, transferred, or otherwise managed as a waste in their area by industrial facilities. In addition, industries have an additional tool for evaluating efficiency and progress on their pollution prevention goals. Responses to the collection of information are mandatory ( see 40 CFR part 372). Respondents may claim all or part of a notice confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2. 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 are listed in 40 CFR part 9 and 48 CFR Chapter 15. Burden Statement: Under the PRA, `` 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. For this collection, it 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; 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. The ICR supporting statement provides a detailed explanation of this estimate, which is only briefly summarized in this notice. The annual public burden for this collection of information is estimated to average 19.5 hours per response. The following is a summary of the estimates taken from the ICR: Respondents/ affected entities: Entities potentially affected by this action are owners or operators of certain facilities that manufacture, process, or otherwise use certain specified toxic chemicals and chemical categories and are required to report annually on the environmental releases and transfers of waste management activities for such chemicals. Estimated total number of potential responses: 88,117. Frequency of response: Annual. Estimated total annual burden hours: 2,477,952. Estimated total annual burden costs: $ 107.4 million. Changes in Burden Estimates: As a result of OMB's March 7, 2002 approval of an information correction worksheet, OMB's inventory reflects 145,972 responses and 9,612,104 hours for this information collection. This ICR supporting statement is for 88,117 responses and 2,477,952 hours. The reduction in burden of approximately 7.1 million hours is the result of five adjustments. The first adjustment is to the number of responses. The estimate of 145,972 responses in the existing OMB approval incorporated predicted reporting increases from economic analyses for several final rules. In all cases, these predictions have overestimated actual reporting levels, resulting in a cumulative overestimate of the number of responses. For example, the 1997 program change for industry expansion estimated 39,033 responses would be submitted, but only 12,567 responses were actually submitted. Likewise, the 1999 program change for PBT chemical thresholds estimated 19,990 responses would be submitted, but only about 6,600 responses per year were actually submitted. The number of responses in this ICR supporting statement have been adjusted to accurately reflect actual subsequent year reporting levels, with the exception of predicted additional responses from the rule lowering reporting thresholds for lead and lead compounds. The prediction of 9,813 additional reports for lead and lead compounds may prove to be an overestimate, as with EPA predictions for past rules. Adjusting the number of responses to accurately reflect actual subsequent year reporting levels ( where available) results in a decrease of 59,617 responses from subsequent year filers and approximately 3.1 million burden hours ( at 52.1 hours per response). The second adjustment is to the unit burden hours. EPA has adjusted the estimate of unit burden hours for Form R completion in subsequent years from 47.1 hours to 14.5 hours based on responses from actual TRI reporting facilities. The adjustment to unit burden hours does not affect the number of responses, but reduces total burden by approximately 2.8 million burden hours ( using the number of subsequent year responses for this ICR). The third adjustment relates to firstyear reporting burden. In previous ICRs, the renewal period has coincided with programmatic changes in one or more years. Previous ICRs have been based on annualized estimates of burden ( including time for rule familiarization and higher first year reporting burdens for facilities affected by programmatic changes). Since there are no final rules pending at this time, this ICR renewal does not require annualized burden estimates that account for first year reporting burden by facilities affected by programmatic changes. However, the ICR does account for a baseline level of first time filers that are new to TRI reporting each year. This accounts for a reduction of about 900,000 burden hours. The fourth adjustment relates to the adoption of TRI   ME, an automated reporting software package. EPA has reduced the burden estimates related to Form R Completion and Recordkeeping/ Submission by 25 percent for the reports filed using TRI   ME. On an annualized basis, an estimated 60 percent of reports are expected to be filed using TRI   ME over the three years of the ICR. This results in a reduction of approximately 270,000 hours. The fifth adjustment relates to the number of petitions. In previous ICRs, EPA has estimated 11 petitions per year. Since the actual number has been 1 to 2 per year, this ICR renewal has reduced the expected number of petitions to 5. This adjustment has a very minor impact on total burden.

VerDate 0ct< 31> 2002 19: 04 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 04DEN1. SGM 04DEN1 72170 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Notices The sum of these adjustments is a decrease of 57,855 responses and 7,134,152 burden hours from the current approved total. According to the procedures prescribed in 5 CFR 1320.12, EPA has submitted this ICR to OMB for review and approval. Any comments related to the renewal of this ICR should be submitted within 30 days of this notice, as described above.

Dated: November 22, 2002. Oscar Morales, Director, Collection Strategies Division, Office of Environmental Information. [ FR Doc. 02   30762 Filed 12   3   02; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OPP   2002   0250; FRL   7274   7]

Fenarimol; Availability of the Risk Assessments on FQPA Tolerance Reassessment Progress and Tolerance Reassessment Decision ( TRED)

AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the availability of EPA's tolerance reassessment decision and related documents for fenarimol including the Fenarimol Overview, Fenarimol Summary, Fenarimol Decision Document ( TRED), and supporting risk assessment documents. EPA has reassessed the 42 tolerances, or legal limits, for residues of fenarimol in or on raw agricultural commodities. These tolerances are now considered safe under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act ( FQPA) of 1996. DATES: Comments on the tolerance reassessment decision or on the human health effects risk assessment for fenarimol, identified by docket ID number OPP   2002   0250, must be received by EPA on or before January 3, 2003. In the absence of substantive comments, the tolerance reassessment decision will be considered final. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP   2002   0250 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: Tom Myers, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308   8589; email address: myers. tom@ epa. gov. SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

This action is directed to the public in general, but will 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 use of pesticides. The Agency has not attempted to describe all the persons or entities who may be interested in or affected by this action. If you have questions in this regard, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations,'' `` Regulations and Proposed Rules,'' and then look up the entry for this document under the `` Federal Register   Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. You can obtain copies of the TRED and related documents discussed in this notice on EPA's website at http:// www. epa. gov/ pesticides/ reregistration/ status. htm. Information on pesticide reregistration and tolerance reassessment, including the purpose and status of Agency programs to complete Reregistration Eligibility Decisions ( REDs), Interim REDs, and tolerance reassessment decisions ( TREDs), is available at http:// www. epa. gov/ pesticides/ reregistration. General information is available on the Office of Pesticide Programs' home page, http:// www. epa. gov/ pesticides/. 2. In person. The Agency has established an official record for this action under docket ID numbers OPP   2002   0250. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305   5805.

C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP   2002   0250 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305   5805. 3. Electronically. You may submit your comments electronically by e mail to: opp docket@ epa. gov, or you can submit a computer disk as described in this unit. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/ 8.0/ 9.0 or ASCII file format. All comments in electronic form must be identified by docket ID number OPP   2002   0250. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI that I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that VerDate 0ct< 31> 2002 19: 04 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 04DEN1. SGM 04DEN1


[Federal Register Volume 77, Number 106 (Friday, June 1, 2012)]
[Proposed Rules]
[Pages 32441-32444]
[FR Doc No: 2012-13290]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 121

[Docket No. FAA-2011-0045]

Proposed Legal Interpretation

AGENCY: Federal Aviation Administration (FAA).

ACTION: Proposed interpretation.

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SUMMARY: The FAA is considering clarifying prior legal interpretations
regarding pilot in command discretion under 14 CFR 121.547(a)(3) and
(a)(4).

DATES: Comments must be received on or before July 31, 2012.

ADDRESSES: You may send comments identified by Docket Number FAA-2011-
0045 using any of the following methods:
    Federal eRulemaking Portal: Go to http://www.regulations.gov and
follow the online instructions for sending your comments
electronically.

    Mail: Send comments to Docket Operations, M-30; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., Room W12-140, West Building
Ground Floor, Washington, DC 20590-0001.
    Hand Delivery or Courier: Bring comments to Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sara Mikolop, Attorney, Regulations
Division, Office of the Chief Counsel, Federal Aviation Administration,
800 Independence Avenue SW., Washington, DC 20591; telephone: 202-267-
3073.

SUPPLEMENTARY INFORMATION: On May 12, 2010, the FAA received a request
for a legal interpretation from the Independent Pilots Association
(IPA) regarding the consequences of deadhead transportation in
connection with flight time limitations for flag operations, and the
conditions for admission to an aircraft flight deck found in 14 CFR
121.547 and the United Parcel Service Flight Operations Manual (UPS
FOM). We propose a three-part response to IPA's inquiry. First, we will
address the issues regarding deadhead transportation. Second, we will
address the issues regarding admission to the flight deck, in which we
propose to clarify prior interpretations regarding pilot in command
discretion under 14 CFR 121.547(a)(3) and (a)(4). Third, we will
address the issues regarding certain provisions in the UPS FOM
regarding admission to the flight deck.

I. Deadhead Transportation \1\
---------------------------------------------------------------------------

    \1\ We assume for purposes of this proposed legal interpretation
that all operations are conducted under the flag operating rules.
Thus, the analysis of flight time limitations in this proposed legal
interpretation is limited to the current applicable flight time
limitations found in subpart R of part 121.
---------------------------------------------------------------------------

    An individual is considered to be in deadhead transportation when
an employing air carrier requires that individual to ride as a
passenger to a location at which he or she will serve as a flightcrew
member or from a location at which the individual was relieved from
duty as a flightcrew member to return to his home station.\2\ See 14
CFR 121.471(f); Legal Interpretation from Donald P. Byrne to James W.
Johnson (May 9, 2003). In order to qualify as deadhead transportation,
the transportation (1) Cannot be local in character, (2) must be
required of the flightcrew member by the air carrier and, (3) must be
arranged by the air carrier. See Legal Interpretation 1992-48. Assuming
that all three of these qualifiers are met, an individual assigned by a
certificate holder to a flight, without being assigned to any duties
during that flight, will be considered to be in deadhead
transportation. We caution, however, that deadhead transportation is
not considered part of a flightcrew member's rest period under any of
the regulations governing flight time limitations. See 14 CFR
121.471(f), 121.491 and 121.519.
---------------------------------------------------------------------------

    \2\ 14 CFR 121.471(f) (flight time limitations applicable to
domestic operations) provides a description of deadhead
transportation which is used in the same context throughout the part
121 regulatory framework for domestic, flag and supplemental flight
time limitations. Section 121.471(f) states, ``Time spent in
transportation, not local in character, that a certificate holder
requires of a flight crewmember and provides to transport the
crewmember to an airport at which he is to serve on a flight as a
crewmember, or from an airport at which he was relieved from duty to
return to his home station, is not considered part of a rest
period.''
---------------------------------------------------------------------------

    Although time spent in deadhead transportation is not included as
part of a flightcrew member's rest, it is also not included in
calculations of flight time limitations for a flightcrew member engaged
in flag operations. Flight time limitations for flightcrew members in
flag operations are found in subpart R of part 121. Subpart R, places
limits on the amount of time an individual may act or may be scheduled
to act as a flightcrew member for an air carrier. For purposes of
determining compliance with the flight time limitations in subpart R,
flight time calculations are based on total block-to-block time. See
Legal Interpretation 1997-20; Legal Interpretation 1990-27 (stating
that the language in Sec.  121.483(a), ``no carrier may schedule a
pilot to fly * * *,'' prescribes a block-to-block limitation); Legal
Interpretation 1989-1 (distinguishing ``scheduled to fly'' from the
term, ``flight deck duty'' (used in subpart S) which means work as a
flightcrew member on the flight deck).
    These flight time limitations can only be violated when an
individual acts or is scheduled to act as a flightcrew member for an
air carrier. Thus, the time during which one is assigned to deadhead
transportation does not count towards flight time limits because, in
order to be assigned to deadhead transportation, one cannot also be
assigned to a flight as a flightcrew member. However, we must caution
that if a person in deadhead transportation performs duty during the
course of the flight as a pilot, flight engineer, or flight navigator,
that person becomes a flightcrew member. See 14 CFR Sec.  1.1 (defining
a flightcrew member as ``[A] pilot, flight engineer, or flight
navigator assigned to duty in an aircraft during flight time.''). As
such, the total block-to-block time for the flight will accrue towards
the flight time limitations found in subpart R.

II. Admission to the Flight Deck

    IPA's request for interpretation raises two broad issues related to
the application of Sec.  121.547(a) which identifies the individuals
who may be admitted to the flight deck of an aircraft operating under
part 121 and the conditions for such admission.\3\ The first issue we
will address involves the identification of the appropriate provision
within Sec.  121.547(a) by which crewmembers and individuals in
deadhead transportation may be admitted to the aircraft flight deck.
The second issue we will address involves the exercise of pilot in
command (PIC) discretion regarding the admission of certain individuals
to the flight deck.
---------------------------------------------------------------------------

    \3\ Section 121.547(a) states:
    (a) No person may admit any person to the flight deck of an
aircraft unless the person being admitted is--
    (1) A crewmember;
    (2) An FAA air carrier inspector, a DOD commercial air carrier
evaluator, or an authorized representative of the National
Transportation Safety Board, who is performing official duties;
    (3) Any person who--
    (i) Has permission of the pilot in command, an appropriate
management official of the part 119 certificate holder, and the
Administrator; and
    (ii) Is an employee of--
    (A) The United States; or
    (B) A part 119 certificate holder and whose duties are such that
admission to the flightdeck is necessary or advantageous for safe
operation; or
    (C) An aeronautical enterprise certificated by the Administrator
and whose duties are such that admission to the flightdeck is
necessary or advantageous for safe operation.
    (4) Any person who has the permission of the pilot in command,
an appropriate management official of the part 119 certificate
holder and the Administrator. Paragraph (a)(2) of this section does
not limit the emergency authority of the pilot in command to exclude
any person from the flight deck in the interests of safety.
---------------------------------------------------------------------------

    Regarding the first issue raised by IPA, crewmembers may be
admitted to the flight deck pursuant to Sec.  121.547(a)(1) and
individuals in deadhead transportation may be admitted to the flight
deck pursuant to Sec. Sec.  121.547(a)(3) or (a)(4). The regulation
plainly states that only crewmembers may be admitted to the flight deck
of an aircraft under the authority of Sec.  121.547(a)(1). As discussed
earlier in this proposed legal interpretation, an individual assigned
to a flight as a crewmember cannot, at the same time, be assigned to
deadhead transportation.

Thus an individual assigned to deadhead transportation may not be
admitted to the flight deck under Sec.  121.547(a)(1).
    An individual in deadhead transportation may, however, be admitted
to the flight deck under 14 CFR 121.547(a)(3) or (a)(4). Section
121.547(a)(3) allows flight deck access for employees of certain
entities, including employees of part 119 certificate holders, whose
presence on the flight deck is necessary or advantageous for safe
operation. Thus, this provision could be used to allow persons in
deadhead transportation access to the flight deck. Section
121.547(a)(4) is more general than Sec.  121.547(a)(3) in that it
applies to ``any person.''
    The second broad issue raised by IPA involves the PIC's exercise of
discretion regarding flight deck admission under Sec.  121.547(a). This
issue has been discussed in prior legal interpretations examining the
PIC's overall safety responsibility, as well as the implication of the
PIC prior permission requirements that appear in Sec. Sec.
121.547(a)(3) and (a)(4) but not in (a)(1) or (a)(2).
    Individuals who may be admitted to the flight deck under Sec. Sec.
121.547(a)(1) and (a)(2) (i.e., crewmembers, FAA inspectors, Department
of Defense Commercial air carrier evaluators and certain National
Transportation Safety Board representatives) serve a presumed safety
role and as such, are not subject to the same prerequisites for
admission as those individuals identified in Sec. Sec.  121.547(a)(3)
and (a)(4). In contrast with Sec. Sec.  121.547(a)(1) and (a)(2),
admission to the flight deck under either Sec. Sec.  121.547(a)(3) or
(a)(4) requires prior permission from the PIC, the FAA Administrator
and an appropriate management official of the certificate holder. In
promulgating Sec. Sec.  121.547(a)(3) and (a)(4), the FAA has
recognized a legitimate need to allow individuals who do not fall
within Sec. Sec.  121.547(a)(1) and (a)(2) onto the flight deck. The
FAA has also recognized that this need for flight deck access does not
arise out of a presumed safety need. Accordingly, the PIC has greater
latitude to deny an individual access to the flight deck under
Sec. Sec.  121.547 (a)(3) and (a)(4).
    In prior legal interpretations, we stated that the PIC permission
provision provides the PIC unfettered discretion whether to admit
certain individuals to the flight deck under a Sec. Sec.  121.547(a)(3)
or (a)(4) situation. See Legal Interpretation from Joseph A. Conte to
Brigitte Lakah (December 16, 2002); Legal Interpretation 2001-7. But
see Legal Interpretation 2003-1 (distinguishing a ``pure'' Sec. Sec.
121.547(a)(3) or (a)(4) situation as the only time the PIC has
unfettered discretion and stating that a ``pure'' Sec. Sec.
121.547(a)(3) or (a)(4) situation does not exist when an individual's
presence on the flight deck is required by another rule (e.g., Sec.
121.550 regarding secret service agents)). We based these
interpretations on the rationale that a PIC's safety authority would be
undermined if his or her decision to deny permission for certain people
to enter the flight deck in a Sec. Sec.  121.547 (a)(3) or (a)(4)
situation was challenged by his or her employer. See Legal
Interpretation 2003-1 (indicating that post flight disciplinary
proceedings taken by an air carrier in a pure Sec. Sec.  121.547(a)(3)
or (a)(4) situation interferes with the duties and responsibilities
required of a PIC by regulation); Legal Interpretation from Joseph A.
Conte to Brigitte Lakah (December 16, 2002) (stating that second-
guessing a PIC's decision to deny permission for certain people to
enter the flight deck would undermine ``[T]he safety underpinning for
having a `PIC-permission-provision' in the regulations.''); Legal
Interpretation 2001-7.
    The PIC bears the responsibility for the safety of the passengers,
crew, cargo and aircraft during flight. See 14 CFR 91.3 and 121.535(e)-
(f). To that end, it continues to be the PIC's decision as to whether
there is a safety-related reason for excluding from the flight deck an
individual eligible for admission under Sec. Sec.  121.547(a)(3) or
(a)(4). See e.g. Legal Interpretation 2001-7 (identifying numerous
potential reasons for denying admission to the flight deck in a
Sec. Sec.  121.547(a)(3) or (a)(4) situation such as rough weather,
distraction to flightcrew, a complex operation requiring heightened
attention by the flightcrew, all of which are safety-related).
    However, to the extent that prior legal interpretations state or
simply imply that air carriers have no ability to question a PIC in
their employ regarding his or her decision to deny flight deck access
to an individual for a reason that is not based on a safety concern, we
believe the agency overstated its position. Accordingly, we propose to
rescind the relevant portions of those prior legal interpretations. The
FAA believes that at an appropriate time and venue, air carriers must
be able to question why a PIC decided to exclude certain individuals
from the flight deck when there was no apparent safety issue.
    While, as we have stated above, the PIC is responsible for the
safety of the passengers, crew, cargo and aircraft during flight, we
also hold air carriers responsible for the safe conduct of all aspects
of their operations. See generally 14 CFR part 121. But, limiting air
carriers' ability to manage their workforce, when there is no apparent
risk to aviation safety, is outside the scope of the agency's safety
oversight responsibilities.
    The FAA's interest is in promoting safety and as such, we would be
concerned with any action by the carrier that could reasonably impact
the ability of the PIC to exercise his or her authority to make a
determination that access to the flight deck needs to be denied for the
safety of the operation. To that end, the agency presumption in any
investigation will be that the PIC acted appropriately. The FAA
expects, however, that the PIC will be able to articulate a safety-
related reason for denying access to the flight deck in situations
subject to Sec. Sec.  121.547(a)(3) and (a)(4).

III. United Parcel Service Flight Operations Manual

    The United Parcel Service Flight Operations Manual (UPS FOM)
provides for the UPS implementation of Sec.  121.547(a). See UPS FOM,
Administration, Jumpseat Policies and Procedures, 02-04, Priority
Descriptions (Rev No: 40, Rev Date: 08/31/10). The UPS FOM includes a
list that describes numerous categories of potential jumpseat occupants
and provides a priority order for their carriage. See id. The
categories of potential jumpseat occupants include potential
crewmembers and individuals in deadhead transportation. See id. The UPS
FOM identifies as ``Priority 3A'' jumpseat occupants, ``UPS crewmembers
who have been provided a commercial ticket for a deadhead, but elect to
travel via the Company jumpseats instead * * *'' See id. The UPS FOM
identifies, ``U.S. Government couriers (U.S. Government employees
only), Loadmasters, UPS Maintenance and Flight Operations personnel * *
* (Note)'' as priority 3 jumpseat occupants. The ``Note'' referred to
in the priority 3 description further explains the priority 3 jumpseat
occupants as follows:

    Note:  Priority 3 UPS crewmember flight deck occupants are
important to UPS flight operations. These priority 3 flight deck
occupants are UPS-assigned other crewmembers and these on-duty
crewmembers will assist the operating crew at the direction of the
Captain during normal and emergency operations. These duties enhance
the security and safety of the flight operation; thus, these
crewmembers gain

admission to the flight deck under FAR 121.547 (a)(1). As a result,
the Captain's discretion, regarding these other crewmembers, is not
unfettered. The exclusion of these crewmembers from the flight deck
requires that the Captain has a compelling explanation, which is
valid only if an emergency situation exists whereby the presence of
these crewmembers is not in the interests of aviation safety.

    See id. Based on the note associated with the description of
individuals identified for priority 3 status by the UPS FOM, it appears
that UPS intends for loadmasters and UPS maintenance and flight
operations personnel to be assigned to perform duties during flight and
therefore meet the definition of crewmembers. It is possible that these
individuals meet the definition of ``crewmember'' if they are
``assigned to perform duty in an aircraft during flight time.'' See 14
CFR 1.1. See e.g. Legal Interpretation 1986-12 (stating that if a
mechanic employee of an air carrier is assigned duty during flight
time, then the mechanic is a ``crewmember'' and may ride in the
jumpseat pursuant to Sec.  121.547(a)(1)). It is also possible that
some individuals could meet the definition of flightcrew member
depending on their airman qualifications and the type of duty assigned,
thus triggering the flight time limitations in Subpart R.\4\ For
purposes of evaluating compliance with Sec.  121.547(a), the priority
descriptions in the UPS FOM are not determinative. A determination as
to whether a jumpseat occupant meets the definition of crewmember or
flightcrew member for a particular operation would have to be made on a
case-by-case basis because the language in the UPS FOM does not provide
sufficient detail to make a blanket determination. If a particular
jumpseat occupant meets the definition of flightcrew member or
crewmember then this individual would gain admission to the flight deck
under Sec.  121.547(a)(1). If it is determined that a particular
individual seeking admission to the flight deck has been assigned to
the flight for purposes of deadhead transportation, with the intent
that he or she travel primarily as a passenger, then this individual
may gain access to the flight deck with the approvals described in
Sec. Sec.  121.547(a)(3) or (a)(4).
---------------------------------------------------------------------------

    \4\ 14 CFR 121.385(a) provides the regulatory framework for
required crewmembers. It states, ``No certificate holder may operate
an airplane with less than the minimum flight crew in the
airworthiness certificate or the Airplane Flight Manual (AFM)
approved for that type airplane and required by this part for the
kind of operation being conducted.'' To the extent that a
certificate holder assigns a deadheading individual, flightcrew
member or crewmember to a particular operation and that individual
is not required for the operation by the aircraft type certificate,
operating regulations or AFM, the FAA would not view that individual
as a ``required crewmember'' for purposes of compliance with 14 CFR
121.385(a).

    Issued in Washington, DC, on May 24, 2012.
Rebecca B. MacPherson,
Assistant Chief Counsel for Regulations, AGC-200.
[FR Doc. 2012-13290 Filed 5-31-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Notices]
[Pages 23798-23801]
[FR Doc No: 2015-09884]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0090]

Retrospective Review of Premarket Approval Application Devices;
Striking the Balance Between Premarket and Postmarket Data Collection

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
progress of the Center for Devices and Radiological Health (CDRH) on
its 2014-2015 Strategic Priority ``Strike the Right Balance Between
Premarket and Postmarket Data Collection.'' To achieve this priority,
CDRH established a goal to assure the appropriate balance between
premarket and postmarket data collection to facilitate and expedite the
development and review of medical devices, in particular high-risk
devices of public health importance, and established a target date of
December 31, 2014, by which to review 50 percent of product codes
subject to a premarket approval application (PMA) that are legally
marketed to determine whether or not, based on our current
understanding of the technology, to rely on postmarket controls to
reduce premarket data collection, to shift some premarket data
collection to the postmarket setting, or to pursue down-classification.
CDRH has taken such actions periodically in the past consistent with
the medical device statutory framework but typically has done so on an
ad hoc basis. CDRH also will require more data or up-classify a device,
if warranted, based on the current state of the science; however, up-
classification is not warranted for the devices subject to this
retrospective review because they are already in the highest risk
classification. In this document, CDRH is providing its current
thinking on reviewed product types to solicit comments on the product
codes that have been identified as candidates for reclassification, for
reliance on postmarket controls to reduce premarket data collection, or
a shift in premarket data collection to the postmarket setting.

DATES: Submit either electronic or written comments by June 29, 2015.
See section IV for more information on how to submit comments to this
document and properly identify the device(s) the comment concerns.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. Identify comments with the docket number found in
brackets in the heading of this document and with the product code(s)
for the device(s) the comment concerns.

FOR FURTHER INFORMATION CONTACT: Nancy Braier, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5454, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    One of three Strategic Priorities for 2014-2015 in CDRH is to
``Strike the Right Balance Between Premarket and Postmarket Data
Collection'' (Ref. 1).\1\ CDRH's vision is for patients in the United
States to have first in the world access to high-quality, safe, and
effective medical devices of public health importance. A key
determinant of early U.S. patient access to high-quality, safe, and
effective devices is the extent of premarket data that device
developers provide to FDA. Once a device developer decides to seek U.S.
marketing approval or clearance, the extent of data that is collected
premarket has an impact upon the length of time needed to complete a
premarket submission--the more data to be collected premarket, the
longer it may take to acquire the data and make the submission.
Consequently, such data collection issues affect when U.S. patients
have access to a medical device. On the other hand, it is also
important that there is sufficient data to demonstrate a reasonable
assurance of safety and effectiveness before a device subject to a
premarket approval application (PMA) is approved for marketing in the
United States. For this reason, it is important that CDRH strike the
right balance between premarket and postmarket data collection. If CDRH
can shift--when appropriate--some premarket data collection to the
postmarket setting, CDRH could improve patient access to high-quality,
safe, and effective medical devices of public health importance.
However, patient safety could be undermined if CDRH shifted some data
collection from the premarket to the postmarket setting without
adequate assurances that necessary and timely data collection will
occur. For this reason, CDRH strives to balance the premarket data and
postmarket collection, in accordance with section 513(a)(3)(C) (21
U.S.C. 360c(a)(3)(C)) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act), which directs CDRH to consider whether the extent of data
that otherwise would be required for approval of a PMA with respect to
effectiveness can be reduced through reliance on postmarket controls.
---------------------------------------------------------------------------

    \1\ CDRH's 2014-2015 Strategic Priorities include ``Strengthen
the Clinical Trial Enterprise'' and ``Provide Excellent Customer
Service,'' in addition to ``Strike the Right Balance Between
Premarket and Postmarket Data Collection'' (Ref. 1).

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

    In order to achieve the proper balance between premarket and
postmarket data collection, CDRH resolved in its Strategic Priorities
for 2014-2015 to take several actions. CDRH committed to developing and
seeking public comment on a framework for when it would be appropriate
to shift premarket data collection to the postmarket setting. Pursuant
to this commitment, CDRH and the Center for Biologics Evaluation and
Research (CBER) issued the draft guidance, ``Balancing Premarket and
Postmarket Data Collection for Devices Subject to Premarket Approval''
on April 23, 2014 (78 FR 22690). This draft guidance proposed an FDA
policy of balancing premarket and postmarket data collection during the
Agency's review of PMAs. This guidance outlined how FDA would consider
the role of postmarket information in determining the appropriate type
and amount of data that should be collected in the premarket setting to
support premarket approval, while still meeting the statutory standard
of a reasonable assurance of safety and effectiveness. Comments on this
draft guidance were collected through July 22, 2014, and the guidance
was finalized on April 13, 2015 (Ref. 2). Furthermore, under existing
authorities, CDRH and CBER issued a draft guidance document on April
23, 2014 (78 FR 22691), entitled ``Expedited Access for Premarket
Approval Medical Devices Intended for Unmet Medical Need for Life
Threatening or Irreversibly Debilitating Diseases or Conditions.'' This
draft guidance described FDA's proposal for a new, voluntary expedited
access PMA program for certain medical devices to facilitate patient
access to these devices by expediting the development, assessment, and
review of certain devices that demonstrate the potential to address
unmet medical needs for life threatening or irreversibly debilitating
diseases or conditions. To expedite access for devices addressing unmet
needs, this pathway to market would shift appropriate premarket data
collection to the postmarket setting while maintaining the statutory
standard of a reasonable assurance of safety and effectiveness.
Comments on this draft guidance were collected through July 22, 2014,
and the guidance was finalized and issued on April 13, 2015 (Ref. 3).
In addition, CDRH is currently developing a mechanism to prospectively
assure the appropriate balance of premarket and postmarket data
collection for new devices subject to a PMA.
    Another action in pursuit of the goal to strike the right balance
between premarket and postmarket data collection is to commit to
conducting a retrospective review of all PMA product codes (procodes)
with active PMAs approved prior to 2010 to determine whether data
typically collected premarket could be shifted to the postmarket
setting, premarket data collection could be reduced through reliance on
postmarket controls, or devices could be reclassified (down-classified)
in light of our current understanding of the technology (Ref. 1). In
general, some premarket data collections for class III devices that are
currently marketed may be reduced through reliance on postmarket
controls, or shifted to the postmarket setting if warranted based on
CDRH's review experience as well as the postmarket performance and the
current body of evidence regarding the benefit-risk profile of these
devices. CDRH currently receives PMA submissions on the majority of
these class III devices, and a change in premarket data collection is
expected to expedite the approval of future PMA submissions. CDRH has
periodically taken such actions consistent with the medical device
statutory framework but has typically done so on an ad hoc basis. On
the other hand, CDRH routinely requires more data when warranted based
on our current understanding of that type of technology or based on
issued raised by the data submitted by a sponsor for their device. CDRH
will also up-classify a device, if warranted, based on the current
state of the science. For example, in May 2014, CDRH proposed to up-
classify surgical mesh when intended for use for pelvic organ prolapse
(79 FR 24634), and in June 2014, CDRH issued a final order up-
classifying sunlamps and sunlamp products (tanning beds/booths) (79 FR
31205). However, up-classification is not warranted for the devices
subject to this retrospective review, because they are already in the
highest risk classification.
    During this retrospective review, the devices are analyzed
according to procode. CDRH targeted the date of December 31, 2014, to
review 50 percent of procodes subject to a PMA that are legally
marketed to determine whether or not to change premarket data
collection by shifting to the postmarket setting, reducing premarket
data collection through reliance on postmarket controls, or pursuing
reclassification (Ref. 1). This target extends to have 75 percent
completed by June 30, 2015, and 100 percent completed by December 31,
2015.
    The purpose of this Federal Register notice is to solicit comments
on the procodes that have been identified as candidates for
reclassification, a reduction in premarket data collection through
reliance on postmarket controls, or a shift in premarket data
collection to postmarket for those procodes reviewed through December
31, 2014. Efforts to reclassify and to communicate changes to data
collections with stakeholders will be prioritized based on both the
public health impact and Center resources.

II. Progress Toward Goal Targets

    Retrospective analysis of the class III medical device procodes is
intended to determine if current classifications and data collections
remain appropriate for determining a reasonable assurance of safety and
effectiveness. As our understanding of the technology associated with
individual medical devices has increased and we have a better
understanding of the risks associated with the technology of each
device, the type and amount of data that is needed to demonstrate a
reasonable assurance of safety and effectiveness evolve. This evolution
to require the least burdensome amount of data to evaluate device
effectiveness follows the least burdensome provisions of the FD&C Act
(section 513(a)(3)(D)(ii)). Under section 513 of the FD&C Act, a device
is a class III device and requires premarket approval if general
controls and special controls are insufficient to provide reasonable
assurance of the safety and effectiveness of the device, and if the
device is to be used for supporting or sustaining human life or of
substantial importance in preventing impairment of human health or if
the device presents a potential unreasonable risk of illness or injury.
In order to reclassify a class III device into class II, the device
must meet the statutory criteria for class II: A device which cannot be
classified as a class I device, because general controls are
insufficient to provide reasonable assurance of the safety and
effectiveness of the device, and for which there is sufficient
information to establish special controls to provide such assurance. As
new information becomes available over time, the accumulated
information available for a device may be sufficient to establish
special controls to provide a reasonable assurance of safety and
effectiveness; therefore, the classification of the device may be
changed either up or down.
    In February 2014, CDRH began its retrospective review with procodes
associated with active PMAs approved prior to 2010. PMA procodes
created since 2010 were not included in this retrospective review
because these

recently created procodes do not yet have sufficient new information
for a change in FDA's current understanding of the device's postmarket
performance profile. As of December 31, 2014, CDRH reviewed 69 percent
of the procodes included in this retrospective review, exceeding its 50
percent review target.
    The results of this analysis include recommendations for procodes
that are candidates for reclassification, a reduction in premarket data
collection through reliance on postmarket controls, or a shift in
premarket data collection to postmarket collection. These results are
published online at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/default.htm. As discussed in further detail, for the purposes of this
retrospective review, we evaluated each procode on a balance of factors
to determine the current benefit-risk profile and if our review
indicates special controls could be established to provide a reasonable
assurance of safety and effectiveness. If so, the corresponding procode
was listed in the category ``Candidates for Reclassification to Class
II'' (Table 1). If it was determined that special controls would not be
sufficient to provide reasonable assurance of the safety and
effectiveness of the device, then the procode was evaluated to
determine if some premarket data collection for PMA submission could be
shifted to postmarket collection, or if premarket data collection could
be reduced through reliance on postmarket controls. If it was
determined that a change of data collection could continue to provide
reasonable assurance of the safety and effectiveness of the device,
then the procode was listed in the category ``Candidates for reduction
of data collection through reliance on postmarket controls or shift of
data collection from premarket to postmarket'' (Table 2). This category
includes procodes for which premarket data collection could be shifted
to postmarket data collection, premarket data collection could be
decreased through reliance on postmarket controls, or postmarket data
could no longer be needed. Finally, Table 3 includes procodes for which
a reduction in data collection through reliance on postmarket controls
or shift in data collection from premarket to postmarket and/or
reclassification occurred in 2014, during FDA's retrospective review of
PMAs.
    In this retrospective review, postmarket performance data,
technology and performance considerations, and other relevant
considerations were evaluated for each procode. These factors were used
to evaluate the current benefit-risk profile to determine if the
devices are good candidates for a reduction in premarket data
collection through reliance on postmarket controls, a shift of
premarket data collection to postmarket, or reclassification.
Postmarket performance data (including recent PMA Annual Reports,
literature reviews, total product lifecycle reports, medical device
reporting analysis, market penetration, and recall analysis) were
investigated for any performance concerns or problems that outpace any
increases in device use or acceptance. In evaluating the technology and
performance considerations for the procodes, performance concerns or
problems that were uncovered in the review of postmarket data were
considered unfavorable factors for a change in data collection or
reclassification. Favorable factors to indicate a device is a good
candidate for a change in data collection or reclassification included
if risks are now well understood and determined to be moderate to low,
technology uncertainties have been alleviated, performance standards or
non-clinical tests have been developed that could be surrogates for
some clinical testing, the need for a controlled study could be
eliminated due to defined objective performance criteria, the device
has been shown to have good short-term performance, or concerns are
limited to long-term performance or rare adverse events.
    Finally, several relevant considerations were evaluated for each
procode. Unfavorable factors for devices to be considered candidates
for a change in data collection or reclassification included if there
have been significant changes implemented to address safety or
effectiveness since the devices have been on the market or if the
review of annual reports and manufacturing changes has been important
to maintain safety of the devices. Furthermore, if there were a limited
number of approvals or limited clinical use of the devices, this was
considered an additional unfavorable factor for the devices to be
considered candidates for a change in data collection or
reclassification, due to inadequate data needed to conduct this
scientific assessment.
    After completion of this retrospective review, FDA will prioritize
the procodes identified as candidates for reclassification (Table 1)
according to public health impact and Center resources, in order to
determine the top priority procodes for which reclassification would
have the greatest impact. The procodes identified as top priority
candidates for reclassification will proceed through the
reclassification procedures according to 21 CFR part 860. FDA will also
prioritize the procodes identified as candidates for a change in data
collection (Table 2) according to public health impact and Center
resources, in order to determine which reductions of or shifts to data
collection would have the greatest impact. The FDA encourages firms to
submit a presubmission to get feedback on their data collection plan or
contact the appropriate review branch for additional information if
they are in the process of developing a device in one of these
categories.

III. Paperwork Reduction Act of 1995

    This document 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 814 have been approved under
OMB control number 0910-0231.

IV. Comments

    Interested persons may submit either electronic comments regarding
this document 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 and the product
code(s) for the device(s) the comment concerns. Citizen petitions and
petitions for reclassification should not be submitted to the docket.
Rather, for instructions on how to appropriately submit citizen
petitions and petitions for reclassification, please see 21 CFR 10.30
and 860.123, respectively. 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.

V. 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.

1. FDA, ``CDRH 2014-2015 Strategic Priorities,'' 2014, available at
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM384576.pdf.

2. ``Guidance for Industry and FDA Staff: Balancing Premarket and
Postmarket Data Collection for Devices Subject to Premarket
Approval,'' April 2015, available at<EMAIL_ADDRESS>3. ``Guidance for Industry and FDA Staff: Expedited Access for
Premarket Approval and De Novo Medical Devices Intended for Unmet
Medical Need for Life Threatening or Irreversibly Debilitating
Diseases or Conditions,'' April 2015, available at<EMAIL_ADDRESS>
    Dated: April 22, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-09884 Filed 4-28-15; 8:45 am]
 BILLING CODE 4164-01-P