[Federal Register Volume 84, Number 121 (Monday, June 24, 2019)]
[Proposed Rules]
[Pages 29423-29426]
[FR Doc No: 2019-13194]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0425; Product Identifier 2016-NE-13-AD]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede airworthiness directive (AD)
2016-24-08 which applies to all Rolls-Royce plc (RR) RB211-Trent 875-
17, RB211-Trent 877-17, RB211-Trent 884-17, RB211-Trent 884B-17, RB211-
Trent 892-17, RB211-Trent 892B-17, and RB211-Trent 895-17 model
turbofan engines. AD 2016-24-08 requires repetitive inspections of the
engine upper fairing and repair or replacement of any fairing that
fails inspection. Since the FAA issued AD 2016-24-08, RR has developed
a modification of the engine upper bifurcation nose fairing assembly
that terminates the inspection requirements of this AD. This proposed
AD would continue the repetitive inspections until the terminating
action is performed at the next engine shop visit. The FAA is proposing
this AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by August 8,
2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Rolls-
Royce plc, Corporate Communications, P.O. Box 31, Derby, England, DE24
8BJ; phone: 011-44-1332-242424; fax: 011-44-1332-249936; email: http://www.rolls-royce.com/contact/civil_team.jsp; internet: https://customers.rolls-royce.com/public/rollsroycecare. You may view this
service information at the FAA, Engine and Propeller Standards Branch,
1200 District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0425; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the mandatory continuing airworthiness information, the
regulatory evaluation, any comments received, and other information.
The street address for Docket Operations is listed above. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Eugene Triozzi, Aerospace Engineer,
ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone:
781-238-7148; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2019-0425;
Product Identifier 2016-NE-13-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. The FAA will
consider all comments received by the closing date and may amend this
NPRM because of those comments.
    The FAA will post all comments we receive, without change, to
http://

www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact we receive about this proposed AD.

Discussion

    The FAA issued AD 2016-24-08, Amendment 39-18725 (81 FR 86567,
December 1, 2016), (``AD 2016-24-08''), for all RR RB211-Trent 875-17,
RB211-Trent 877-17, RB211-Trent 884-17, RB211-Trent 884B-17, RB211-
Trent 892-17, RB211-Trent 892B-17, and RB211-Trent 895-17 model
turbofan engines. AD 2016-24-08 requires repetitive inspections of the
engine upper bifurcation fairing and repair or replacement of any
fairing that fails inspection. AD 2016-24-08 resulted from reports of
cracking and material release from an engine upper bifurcation fairing.
The FAA issued AD 2016-24-08 to prevent failure of the engine fire
protection system, engine fire, and damage to the airplane.

Actions Since AD 2016-24-08 Was Issued

    Since the FAA issued AD 2016-24-08, RR has developed a modification
of the engine upper bifurcation nose fairing assembly. Performance of
this modification terminates the repetitive inspection requirements of
this AD. Also since the FAA issued AD 2016-24-08, the European Union
Aviation Safety Agency (EASA) has issued AD 2018-0088, dated April 18,
2018, which requires repetitive inspections of the engine upper
bifurcation fairing until modification of the engine upper bifurcation
nose fairing assembly at the next engine shop visit.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed RR Service Bulletin (SB) RB.211-72-J803, Revision
1, dated July 13, 2018, and Initial Issue, dated December 7, 2017. This
service information describes procedures for modification of the engine
upper bifurcation nose fairing assembly. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Other Related Service Information

    The FAA reviewed RR Alert Non-Modification Service Bulletin (NMSB)
RB.211-72-AJ165, Revision 2, dated August 21, 2018. This service
information provides guidance on upper bifurcation fairing inspection
locations. The FAA also reviewed AMM TASK 70-20-02, Water Washable
Fluorescent Penetrant Inspection (Maintenance Process 213), and OMat
632, high sensitivity fluorescent penetrant inspection. This service
information provides guidance on performing a fluorescent penetrant
inspection.

FAA's Determination

    The FAA is proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would retain the repetitive inspection
requirements of AD 2016-24-08. This proposed AD would also require
modification of the engine upper bifurcation nose fairing assembly at
the next engine shop visit after the effective date of this AD.

Costs of Compliance

    The FAA estimates that this proposed AD affects 125 engines
installed on airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Inspection............................  3.25 work-hours x $85                 $0         $276.25         $34,531
                                         per hour = $276.25.
Modification of engine upper            2 work-hours x $85 per                50             220          27,500
 bifurcation nose fairing assembly.      hour = $170.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary repairs
or replacements that would be required based on the results of the
proposed inspection. The FAA has no way of determining the number of
engines that might need these repairs or replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Repair of engine upper bifurcation fairing.  8 work-hours x $85 per hour = $680.            $500          $1,180
Replacement of engine upper bifurcation      30 work hours x $85 per hour =                  500           3,050
 fairing.                                     $2,550.
----------------------------------------------------------------------------------------------------------------

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.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs

applicable to engines, propellers, and associated appliances to the
Manager, Engine and Propeller Standards Branch, Policy and Innovation
Division.

Regulatory Findings

    The FAA has determined that this proposed AD would not have
federalism implications under Executive Order 13132. This proposed AD
would not have a substantial direct effect on the States, on the
relationship between the national Government and the States, or on the
distribution of power and responsibilities among the various levels of
government.
    For the reasons discussed above, I certify that the proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

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 removing airworthiness directive (AD)
2016-24-08, Amendment 39-18725 (81 FR 86567, December 1, 2016), and
adding the following new AD:

Rolls-Royce plc: Docket No. FAA-2019-0425; Product Identifier 2016-
NE-13-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by August 8,
2019.

(b) Affected ADs

    This AD replaces AD 2016-24-08, Amendment 39-18725 (81 FR 86567,
December 1, 2016).

(c) Applicability

    This AD applies to all Rolls-Royce plc (RR) RB211-Trent 875-17,
RB211-Trent 877-17, RB211-Trent 884-17, RB211-Trent 884B-17, RB211-
Trent 892-17, RB211-Trent 892B-17, and RB211-Trent 895-17 model
turbofan engines.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7130, Engine
Fireseals.

(e) Unsafe Condition

    This AD was prompted by reports of cracking and material release
from an engine upper bifurcation fairing. The FAA is issuing this AD
to prevent failure of the engine fire control system. The unsafe
condition, if not addressed could result in engine fire and damage
to the airplane.

(f) Compliance

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

(g) Required Actions

    (1) Within 7,500 engine flight hours (FHs) since new, or since
the last inspection, or within 150 flight cycles (FCs) after the
January 5, 2017 (the effective date of AD 2016-24-08), whichever
occurs later, inspect the engine upper bifurcation fairing for
cracks or missing material. Use paragraph (g)(3) of this AD to
perform the inspection.
    (2) Repeat the inspection required by paragraph (g)(1) of this
AD within every 7,500 engine FHs since last inspection.
    (3) Inspect the engine upper bifurcation fairing as follows.

    Note 1 to paragraph (g)(3):  Figure 1 of RR Alert Non-
Modification Service Bulletin (NMSB) RB.211-72-AJ165, Revision 2,
dated August 21, 2018, provides guidance on upper bifurcation
fairing inspection locations.

    (i) Visually inspect upper bifurcation fairing seal face 22,
seal support 23, and Zone A for any cracks or material loss on the
right side.
    (A) If fairing seal face 22 is found to have released material,
repair or replace the fairing before further flight.
    (B) If there is a single crack found on fairing seal face 22,
shorter than 6 mm, repair or replace the fairing within 100 engine
FCs, or at the next shop visit, whichever occurs sooner.
    (C) If there is a single crack, longer than 6 mm, found on
fairing seal face 22, repair or replace the fairing within 15 engine
FCs or at the next shop visit, whichever occurs sooner.
    (D) If there are two or more cracks found on fairing seal face
22, replace the fairing within 15 engine FCs or at next shop visit,
whichever occurs sooner.
    (E) If there is any cracking or material loss found on seal
support 23, replace the fairing within 15 engine FCs or at next shop
visit, whichever occurs sooner.
    (ii) If the visual inspection required by paragraph (g)(3)(i) of
this AD does not detect any cracks, fluorescent penetrant inspect
Zone A.
    (A) If a crack shorter than 6 mm is detected, repair or replace
the fairing within 100 engine FCs, or at the next shop visit,
whichever occurs sooner.
    (B) If a crack longer than 6 mm is detected, repair or replace
the fairing within 15 engine FCs or at the next shop visit,
whichever occurs sooner.

    Note 2 to paragraph (g)(3)(ii):  AMM TASK 70-20-02, Water
Washable Fluorescent Penetrant Inspection (Maintenance Process 213),
and OMat 632, high sensitivity fluorescent penetrant inspection,
provide guidance on performing a fluorescent penetrant inspection.

(h) Mandatory Terminating Action

    At the next engine shop visit after the effective date of this
AD, modify the upper bifurcation fairing assembly in accordance with
the Accomplishment Instructions, paragraph 3., of RR Service
Bulletin (SB) RB.211-72-J803, Revision 1, dated July 13, 2018, or
Original Issue, dated December 7, 2017. Installation of a modified
upper bifurcation fairing assembly is terminating action to the
inspections required by paragraphs (g)(1) through (g)(3) of this AD.

(i) Installation Prohibition

    After the effective date of this AD do not install an upper
bifurcation fairing assembly, part number FK25470, onto any engine.

(j) Definition

    For the purpose of this AD, a ``shop visit'' is defined as
induction of an engine into the shop for maintenance involving the
separation of pairs of major mating engine flanges, except that the
separation of engine flanges solely for the purposes of
transportation without subsequent engine maintenance does not
constitute an engine shop visit.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (l) of this AD. You may email your request
to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(l) Related Information

    (1) For more information about this AD, contact Eugene Triozzi,
Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2018-0088, dated April 18, 2018 for more information. You may
examine the EASA AD in the AD docket on the internet at http://www.regulations.gov by searching for and locating it in Docket No.
FAA-2019-0425.
    (3) For service information identified in this AD, contact
Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby,
England, DE24 8BJ; phone: 011-44-1332-242424; fax: 011-44-1332-
249936; email: http://www.rolls-royce.com/contact/civil_team.jsp;
internet: https://customers.rolls-royce.com/public/rollsroycecare.
You may

view this referenced service information at the FAA, Engine and
Propeller Standards Branch, 1200 District Avenue, Burlington, MA
01803. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on June 17, 2019.
Robert J. Ganley,
Manager, Engine & Propeller Standards Branch, Aircraft Certification
Service.
[FR Doc. 2019-13194 Filed 6-21-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 185 (Wednesday, September 24, 2014)]
[Notices]
[Pages 57092-57095]
[FR Doc No: 2014-22747]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0565; FRL-9915-03]

Registration Review; Pesticide Dockets Opened for Review and
Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: With this document, EPA is opening the public comment period
for several registration reviews. Registration review is EPA's periodic
review of pesticide registrations to ensure that each pesticide
continues to satisfy the statutory standard for registration, that is,
the pesticide can perform its intended function without unreasonable
adverse effects on human health or the environment. Registration review
dockets contain information that will assist the public in
understanding the types of information and issues that the Agency may
consider during the course of registration reviews. Through this
program, EPA is ensuring that each pesticide's registration is based on
current scientific and other knowledge, including its effects on human
health and the environment. This document also announces registration
review case closures for 3 H-1,2 Dithiol-3-one,4,5,-dichloro- (RHY-86)
(case 5033) and tepraloxydim (case 7257). In addition, this document
announces the Agency's intent not to open registration review cases for
mepanipyrim (case 7042) and vinclozolin (case 2740) because there are
no longer any active registrations containing either of these
chemicals. The two case closures and the Agency's intent not to open
two registration review cases being announced herein are not open for
public comment.

DATES: Comments must be received on or before November 24, 2014.

ADDRESSES: Submit your comments identified by the docket identification
(ID) number for the specific pesticide of interest provided in the
table in Unit III.A., by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For pesticide specific information contact: The Chemical Review
Manager

for the pesticide of interest identified in the table in Unit III.A.
    For general information contact: Richard Dumas, Pesticide Re-
Evaluation 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>; email address<EMAIL_ADDRESS>
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, farmworker, 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.

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 email. 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.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. Authority

    EPA is initiating its reviews of the pesticides identified in this
document pursuant to section 3(g) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations
for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of
FIFRA provides, among other things, that the registrations of
pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide
product may be registered or remain registered only if it meets the
statutory standard for registration given in FIFRA section 3(c)(5).
When used in accordance with widespread and commonly recognized
practice, the pesticide product must perform its intended function
without unreasonable adverse effects on the environment; that is,
without any unreasonable risk to man or the environment, or a human
dietary risk from residues that result from the use of a pesticide in
or on food.

III. Registration Reviews

 A. What action is the Agency taking?

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide
registrations identified in the table in this unit to assure that they
continue to satisfy the FIFRA standard for registration--that is, they
can still be used without unreasonable adverse effects on human health
or the environment. A pesticide's registration review begins when the
Agency establishes a docket for the pesticide's registration review
case and opens the docket for public review and comment. At present,
EPA is opening registration review dockets for the cases identified in
the following table.

              Table 1--Registration Review Dockets Opening
------------------------------------------------------------------------
                                                       Chemical review
                                                         manager or
  Registration review case        Docket ID No.       regulatory action
        name and No.                                  leader, telephone
                                                     No., email Address
------------------------------------------------------------------------
2-(thiocyanomethylthio)       EPA-HQ-OPP-2014-0405  Sandra O'Neill,
 benzothiazole (TCMTB (Case<PHONE_NUMBER>,
 2625<EMAIL_ADDRESS>1,3-Propanediamine, N-(3-     EPA-HQ-OPP-2014-0406  Tina Pham, (703) 308-
 aminopropyl)-N-dodecyl-                             0125,
 (PAD) (Case 5109<EMAIL_ADDRESS>3(2H)-Isothiazolone, 4,5-     EPA-HQ-OPP-2014-0403  SanYvette Williams,
 dichloro-2-octyl- (DCOIT)<PHONE_NUMBER>,
 (Case 5023<EMAIL_ADDRESS>Bacillus thuringiensis (Case  EPA-HQ-OPP-2011-0705  Jeannine Kausch,
 0247).<PHONE_NUMBER>,
<EMAIL_ADDRESS>Cyhalofop-butyl (Case 7255).  EPA-HQ-OPP-2014-0115  Jolene Trujillo,
<PHONE_NUMBER>,
<EMAIL_ADDRESS>Diclofop-methyl (Case 2160).  EPA-HQ-OPP-2014-0577  Marianne Mannix,
<PHONE_NUMBER>,
<EMAIL_ADDRESS>

Etoxazole (Case 7616).......  EPA-HQ-OPP-2014-0133  Julia Stokes, (703)
                                                     347-8966,
<EMAIL_ADDRESS>Fenpropimorph (Case 5112)...  EPA-HQ-OPP-2014-0404  Donna Kamarei, (703)
                                                     347-0443,
<EMAIL_ADDRESS>Fluroxypyr,1-                 EPA-HQ-OPP-2014-0570  Benjamin Askin,
 methylheptylester (Case<PHONE_NUMBER>,
 7248<EMAIL_ADDRESS>GABA & LGA (Case 6025)......  EPA-HQ-OPP-2014-0109  Menyon Adams, (703)
                                                     347-8496,
<EMAIL_ADDRESS>Imazapic (Case 7234)........  EPA-HQ-OPP-2014-0279  Ricardo Jones, (703)
                                                     347-0493,
<EMAIL_ADDRESS>Imazaquin (Case 7204).......  EPA-HQ-OPP-2014-0224  Wilhelmena
                                                     Livingston, (703)
                                                     308-8025,
<EMAIL_ADDRESS>Polyoxin D Zinc Salt (Case    EPA-HQ-OPP-2014-0108  Manying Xue, (703)
 6076).                                              305-6198,
<EMAIL_ADDRESS>                                                     .
Noviflumuron (Case 7434)....  EPA-HQ-OPP-2014-0566  Dana Friedman, (703)
                                                     347-8827,
<EMAIL_ADDRESS>Streptomyces lydicus WYEC     EPA-HQ-OPP-2014-0608  Kathleen Martin,
 (Case 6088).<PHONE_NUMBER>,
<EMAIL_ADDRESS>Tebufenpyrad (Case 7435)....  EPA-HQ-OPP-2014-0218  Susan Bartow, (703)
                                                     603-0065,
<EMAIL_ADDRESS>Triallate (Case 2695).......  EPA-HQ-OPP-2014-0573  Katherine St. Clair,
<PHONE_NUMBER>,
<EMAIL_ADDRESS>Zinc pyrithione (Case 2480).  EPA-HQ-OPP-2004-0147  Sandra O'Neill,
<PHONE_NUMBER>,
<EMAIL_ADDRESS>------------------------------------------------------------------------

    This notice also announces two case closures and the Agency's
intent not to open a registration review case for two additional
chemicals. The registration review case for 3 H-1,2 Dithiol-3-one,4,5-
dichloro- (RYH-86) (case 5033) is being closed for non-payment of
maintenance fees for the last two remaining registrations. The
tepraloxydim (case 7257) registration review case is being closed
because the last products were canceled in the Federal Register notice
on August 6, 2014 (79 FR 45798) (FRL-9914-09). The ``Notice of
Registration Review Case Closure for Tepraloxydim'' is available in the
docket EPA-HQ-OPP-2014-0246 at http://www.regulations.gov. The Agency
intends not to open registration review cases for vinclozolin (case
2740) and mepanipyrim (case 7042) because there are no longer any
products registered containing these active ingredients. The
cancellation order for the last vinclozolin registrations was issued in
the Federal Register notice on August 13, 2014 (79 FR 47454) (FRL-9914-
00). There are no longer any products registered containing
mepanipyrim. The two cases closures and the Agency's intent not to open
two registration review cases being announced herein are not open for
public comment.

B. Docket Content

    1. Review dockets. The registration review dockets contain
information that the Agency may consider in the course of the
registration review. The Agency may include information from its files
including, but not limited to, the following information:
     An overview of the registration review case status.
     A list of current product registrations and registrants.
     Federal Register notices regarding any pending
registration actions.
     Federal Register notices regarding current or pending
tolerances.
     Risk assessments.
     Bibliographies concerning current registrations.
     Summaries of incident data.
     Any other pertinent data or information.
    Each docket contains a document summarizing what the Agency
currently knows about the pesticide case and a preliminary work plan
for anticipated data and assessment needs. Additional documents provide
more detailed information. During this public comment period, the
Agency is asking that interested persons identify any additional
information they believe the Agency should consider during the
registration reviews of these pesticides. The Agency identifies in each
docket the areas where public comment is specifically requested, though
comment in any area is welcome.
    2. Other related information. More information on these cases,
including the active ingredients for each case, may be located in the
registration review schedule on the Agency's Web site at http://
www.epa.gov/oppsrrd1/registrationreview/schedule.htm.
Information on the Agency's registration review program and its
implementing regulation may be seen at http://www.epa.gov/oppsrrd1/
registrationreview.
    3. Information submission requirements. Anyone may submit data or
information in response to this document. To be considered during a
pesticide's registration review, the submitted data or information must
meet the following requirements:
     To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment period. The Agency may, at its discretion, consider
data or information submitted at a later date.
     The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English and a written transcript
must accompany any information submitted as an audiographic or
videographic record. Written material may be submitted in paper or
electronic form.
     Submitters must clearly identify the source of any
submitted data or information.
     Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency

should reconsider the data or information in the pesticide's
registration review.
    As provided in 40 CFR 155.58, the registration review docket for
each pesticide case will remain publicly accessible through the
duration of the registration review process; that is, until all actions
required in the final decision on the registration review case have
been completed.

    Authority: 7 U.S.C. 136 et seq.

    Dated: September 18, 2014.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2014-22747 Filed 9-23-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Notices]
[Page 51058-51061]
[DOCID:fr18au10-99]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0632; FRL-8840-1]

Web-Distributed Labeling User Acceptance Pilot

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA's Office of Pesticide Programs (OPP) is exploring a new
initiative called ``web-distributed labeling'' (web-distributed
labeling) that would make the most current version of some pesticide
labeling available to users via the Internet. Through this Federal
Register Notice, OPP is announcing its intention to conduct a web-
distributed labeling ``User Acceptance Pilot'' and is soliciting
interest from entities potentially willing to participate in this pilot
program. Through the User Acceptance Pilot, EPA intends to demonstrate
how users could access labeling information using the Internet, thereby
helping EPA determine whether the benefits of web-distributed labeling
would be sufficiently appealing to users that they would be willing to
visit a website to download and use labeling. This notice provides a
brief description of a pilot website and invites participation in
developing a pilot web-distributed labeling website by interested
parties.

DATES: Comments must be received on or before September 17, 2010.

ADDRESSES: Submit your comments identified by the docket identification
(ID) number 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 Facility'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>.

FOR FURTHER INFORMATION CONTACT: Michelle DeVaux, Field and External
Affairs Division, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:703-308-2962; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you provide
pesticide labeling in an electronic format or are interested in
developing a website to deliver pesticide labeling electronically.
Potentially affected entities may include, but are not limited to:
     Data processing, hosting, and related services (NAICS code
518210), i.e., establishments primarily engaged in providing
infrastructure for hosting or data processing services.
     Web search portals (NAICS code 518112), e.g. companies or
individuals that develop or maintain web search portals.
     Internet publishing and broadcasting and Web search
portals (NAICS code 519130), e.g., internet search portals, Web search
portals, and internet search Web sites.
     Persons who manufacture, distribute, sell, apply, or
regulate pesticide products, including agricultural, commercial, and
residential products (NAICS codes 32532 and 32561).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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. How Can I Get Copies of this Document and Other Related Information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0632. 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
Office of Pesticide Programs (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<PHONE_NUMBER>.

II. Background

A. What Action is the Agency Taking?

    Through this Federal Register Notice, OPP intends to identify
parties potentially interested in participating in a web-distributed
labeling User Acceptance Pilot.
    1. Overview. EPA regulates pesticide products under the authority
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
FIFRA establishes a pre-market review and approval system called
``registration.'' With limited exceptions, no pesticide may be sold or
distributed in the United States unless EPA has first issued a
registration for the product. As part of the registration process, EPA
reviews and approves the labeling affixed to or accompanying the
pesticide product. Labeling describes how a pesticide may be used
safely and effectively. Federal law prohibits the use of a pesticide in
a manner inconsistent with its approved labeling. Many pesticide
products are registered for multiple uses, and as a result, the
labeling of the product is often very lengthy.
    Since 2007, EPA has been exploring the possibility of making some
pesticide product labeling available via the Internet. EPA envisions a
system that would make the most current version of pesticide labeling
available to purchasers and users electronically through web-
distribution. For certain segments of pesticide products, portions of
the labeling would no longer physically accompany the pesticide
container. To obtain the pesticide product's full labeling, the
container label would require a user to go to an Internet website.
Users would be able to retrieve crop-specific labeling by entering the
product registration number, the state where the pesticide would be
applied, and use site (e.g., a crop) on which the pesticide would be
applied. In response to this information, the website would provide
streamlined labeling for the user to download that would include only
the information necessary for the particular use requested. When fully
operational, a web-distributed labeling system would also offer
alternate delivery mechanisms for users who cannot access the Internet.
Web-distributed labeling is being proposed initially as a voluntary
option for registrants and would not be appropriate for all pesticide
products. The goal of the web-distributed labeling initiative is to
provide streamlined labeling that contains only the pertinent label
information specific to the state where the pesticide is to be used and
for the particular intended use, thus reducing unrelated directions by
a significant amount. EPA expects this will improve label
comprehension, readability, and compliance.
    EPA is interested in conducting a ``User Acceptance Pilot'' to
research the extent to which users would accept a system requiring them
to obtain labeling via the Internet. The specific goal of the pilot is
to determine whether the benefits of web-distributed labeling would be
sufficiently appealing to users that they would be willing to visit a
website to obtain labeling for a pesticide product. The pilot would
demonstrate how users could access labeling information using the
website and would not involve the actual distribution to users of
actual pesticide product labeling that would rely on the web-
distributed labeling approach.
    2. Background. After receiving a request to consider web-
distributed labeling from State officials responsible for regulation of
pesticide products, EPA formed an internal workgroup to discuss the
possible mechanics of web-distributed labeling and how it would
complement ongoing label improvement programs. The workgroup conducted
extensive stakeholder outreach to individuals and associations to
describe the concept of web-distributed labeling and to solicit
stakeholder feedback. Using the stakeholders' input, the EPA internal
workgroup developed discussion papers to describe some of the details
around specific elements of web-distributed labeling.
    In May 2008, EPA requested formal feedback on web-distributed
labeling from the Pesticide Program Dialogue Committee (PPDC), a
Federal Advisory Committee to the Office of Pesticide Programs. In
response, a PPDC workgroup was formed to review and respond to the
discussion papers developed by EPA. The workgroup includes
representatives from user and grower groups; public interest groups;
trade associations; industry; State, local, and tribal governments;
educational organizations; Federal agencies; and others. From October
2008 through October 2009 the PPDC web-distributed labeling workgroup
met to discuss and provide comment on the papers. A full listing of the
meetings and papers

considered is available at: http://epa.gov/pesticides/ppdc/distr-
labeling/index.html.
    In October 2009, the PPDC workgroup recommended a pilot for web-
distributed labeling that would allow users to test the functionality
of one or several web-distributed labeling websites. The proposed pilot
would be conducted with mock pesticide labeling and would not require
any changes to actual pesticide labeling and any mock pesticide
labeling would not be used to make an actual pesticide application.
Based on the feedback received from the PPDC workgroup, EPA decided to
focus the pilot on soliciting user feedback on the concept of web-
distributed labeling. The pilot is discussed further in Unit II.A.3 and
4.
    3. Pilot specifications. The EPA is looking for entities outside of
EPA to participate in the User Acceptance Pilot. An entity which
volunteers to participate would develop a website from which potential
pesticide users and others can retrieve pesticide product labeling
information appropriate to a specific state and use site. The
website(s) developed for the User Acceptance Pilot will allow users to
do the following:
     Log onto an Internet-accessible website.
     Enter a product registration number or other product
identifier for one of several pre-determined products.
     Select the relevant state/county in which the mock
pesticide application would take place.
     Select the relevant use pattern(s) for the mock pesticide
application to filter the labeling according to use pattern(s).
     View and download from the website the labeling
appropriate for the identified product, use pattern, and state
provided.
    In addition, the pilot websites would:
     Provide web-distributed labeling for at least three
different products. Participants may use product labels of their
choosing and/or, upon request, use mock labels provided by EPA.
     Place a prominent statement on each page of the downloaded
labeling making it clear that the labeling downloaded from the
website(s) was not legally valid for purposes of making a pesticide
application.
     Offer users a mechanism for providing feedback on the web-
distributed labeling experience.
    Participants are not limited to creating a website that meets only
the minimum specifications identified above, and EPA encourages
participants to incorporate other tools and functionality as
appropriate. Possible enhancements for a web-distributed labeling
website are discussed in the Website Functionality discussion paper
available at: http://www.epa.gov/pesticides/ppdc/distr-labeling/jan09/
functionality.pdf.
    4. Pilot evaluation. As noted above, the purpose of the pilot is to
obtain information about users' reactions to a system which requires
them to obtain labeling from the Internet. The results of this research
are important for EPA in deciding to move ahead with further efforts to
develop such a system. Consequently, EPA not only expects participants
in the Pilot to offer users a mechanism for providing feedback on the
web-distributed labeling experience, but also encourages participants
to summarize and submit to EPA the feedback obtained through the pilot.
    The following types of information would be useful to EPA in
assessing the User Acceptance pilot.
    i. Paper labels - what users like and dislike about the current
paper labeling on or accompanying pesticide containers.
    ii. Web-distributed labeling pilot website - the experience of
using the website
     How users would access a web-distributed labeling website,
e.g., whether high speed, dial-up, no online access;
     Ease of navigation (finding web-distributed labeling the
user was looking for); and
     The user's overall experience using the website
    iii. Web-distributed labeling - The reaction to web-distributed
labeling
     Ease in understanding web-distributed labeling
     Ease in following labeling that is partially on container
and partially on web-distributed labeling
     Paper-based format or in the streamlined web-distributed
labeling format preference
     User's impressions of the benefits of web-distributed
labeling
     Potential impact on the user's compliance with labeling
    iv. Other potential features of Web-distributed labeling
     What other information, if any, the user would like to
have that was not offered in the pilot, e.g., calibration instructions,
pest identification guides.
    5. How to participate. Parties (including but not limited to those
listed under Unit I.A.) interested in participating in the User
Acceptance Pilot must respond in writing by September 17, 2010 to the
person identified in the section titled FOR FURTHER INFORMATION CONTACT
with an expression of interest to participate. EPA will schedule a
meeting with all interested parties after EPA has reviewed the
responses to discuss the User Acceptance Pilot and to answer any
questions from potential participants. EPA's goal is to have all User
Acceptance Pilot websites ready for users to test by October 15, 2010.
    Participation in the User Acceptance Pilot is voluntary; however,
those entities who ultimately participate must agree to certain terms
and conditions in order for EPA to evaluate the success of the website,
including the following:
     The website(s) developed for the User Acceptance Pilot
must be accessible to all potential users and at no charge to any
potential user.
     EPA would post information gathered as part of the User
Acceptance Pilot and provided to EPA to the public docket or made
available to EPA to post to the public docket.
     Participation in the User Acceptance Pilot does not
guarantee future involvement or participation in any web-distributed
labeling activity, such as developing a structured labeling interface.
    Parties interested in learning more about participating in the
pilot can find information at http://www.epa.gov/pesticides/regulating/
labels/distribution/index.htm. Discussion papers related to web-
distributed labeling are available at http://epa.gov/pesticides/ppdc/
distr-labeling/index.html. Participants are encouraged to review Web-
Distributed Labeling of Pesticides: Website Functionality (http:/www./
epa.gov/pesticides/ppdc/distr-labeling/jan09/functionality.pdf).

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

    EPA is taking this action under the authority of FIFRA, section
20(a). This section provides that ``The Administrator shall undertake
research . . . with . . . others as may be necessary to carry out the
purposes of [FIFRA].'' Here EPA is seeking to work with parties in the
private sector to obtain information that will help EPA assess whether
pesticides users would accept a web-distributed labeling program. This
information is essential to understanding whether a web-distributed
labeling system would improve users' compliance with pesticide
labeling, thereby reducing risks to human health and the environment.

List of Subjects

    Environmental protection, Internet, labeling, pesticides.

    Dated: August 6, 2010.
Steven Bradbury,
Director, Office of Pesticide Programs.

[FR Doc. 2010-20449 Filed 8-17-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)]
[Notices]
[Pages 10815-10816]
[FR Doc No: 2014-04134]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Food and Drug Administration/Xavier University Global Medical
Device Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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

SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in
cosponsorship with Xavier University, is announcing a public conference
entitled ``FDA/Xavier University Global Medical Device Conference
(MedCon).'' This 3-day public conference includes presentations from
key FDA officials and industry experts with small group breakout
sessions. The conference is intended for companies of all sizes and
employees at all levels.
    Dates and Times: The public conference will be held on May 7, 2014,
from 8:30 a.m. to 5 p.m.; May 8, 2014, from 8:30 a.m. to 5 p.m.; and
May 9, 2014, from 8:30 a.m. to 12:45 p.m.
    Location: The public conference will be held on the campus of
Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-
3073 or<PHONE_NUMBER>.
    Contact Persons: For information regarding this notice: Gina
Brackett, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH
45237,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    For information regarding the conference and registration: Marla
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207,
513-745-3073, email<EMAIL_ADDRESS>    Registration: There is a registration fee. The conference
registration fees cover the cost of the presentations, training
materials, receptions, breakfasts, and lunches for the 3 days of the
conference. Early registration ends March 11, 2014. Advanced
registration rates begin March 12, 2014. Standard registration rates
begin April 9, 2014. There will be onsite registration. The cost of
registration is as follows:

                                         Table 1--Registration Fees \1\
----------------------------------------------------------------------------------------------------------------
                                       Early rate  (through 3/   Advanced rate (3/12/14   Standard rate  (4/9/14
            Attendee Type                       11/14)                 to 4/8/14)               to 5/9/14)
----------------------------------------------------------------------------------------------------------------
Industry.............................                   $1,195                   $1,495                   $1,695
Small Business (<100 employees)......                     $900                   $1,000                   $1,200
Startup Manufacturer.................                     $200                     $250                     $300
Academic.............................                     $200                     $250                     $300
FDA/Government Employee..............               Fee Waived               Fee Waived             Fee Waived.
----------------------------------------------------------------------------------------------------------------
\1\ The following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks.

    To register online for the public conference, please visit the
``Registration'' link on the conference Web site at http://www.XavierMedCon.com. FDA has verified the Web site address, but is not
responsible for subsequent changes to the Web site after this document
publishes in the Federal Register.
    To register by mail, please send your name, title, firm name,
address, telephone and fax numbers, email, and payment information for
the fee to Xavier University, Attention: Mason Rick, 3800 Victory
Parkway, Cincinnati, OH 45207. An email will be sent confirming your
registration.
    Attendees are responsible for their own accommodations. The
conference headquarters hotel is the Cincinnati Hilton Netherlands
Plaza, 35 West 5th Street, Cincinnati, OH, 45202,<PHONE_NUMBER>. Special
conference block rates are available through April 16, 2014. To make
reservations online, please visit the ``Venue/Logistics'' link at
http://www.XavierMedCon.com.
    If you need special accommodations due to a disability, please
contact Marla Phillips (see Contact Persons) at least 7 days in advance
of the conference.

SUPPLEMENTARY INFORMATION: The public conference helps fulfill the
Department of Health and Human Services and FDA's important mission to
protect the public health. The conference will provide those engaged in
FDA-regulated medical devices (for humans) with information on the
following topics:
     Center for Devices and Radiological Health Future Vision
and Strategy Keynote Address;
     European Union Regulations: New Regulations, Company
Strategy, and Open Discussion Forum;
     How to Implement the Unique Device Identification
Requirements;
     Update from the Office of Device Evaluation;
     FDA Regulation of Health Information Technology: Medical
Apps, Cybersecurity, and ``the Cloud'';
     Managing Scientific and Regulatory Disagreement;
     Combination Products;
     FDA Inspectional Approach--Panel with current FDA
investigators;
     Operationalizing Post-Market Surveillance;
     510(k) Process;
     Risk Management;
     Purchasing Controls;
     Office of Compliance Update; and
     Strategic Thinking on Access in China.
    FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The conference helps to achieve objectives set forth
in section 406 of the Food and Drug Administration Modernization Act of
1997 (21 U.S.C. 393), which includes working closely with stakeholders
and maximizing the availability and clarity of information to
stakeholders and the public. The conference also is consistent with the
Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L.
104-121) by providing outreach activities by Government Agencies to
small businesses.

    Dated: February 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04134 Filed 2-25-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 75, Number 233 (Monday, December 6, 2010)]
[Notices]
[Pages 75677-75678]
[FR Doc No: 2010-30433]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0595]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Exports: Notification and Recordkeeping Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the notification and
recordkeeping requirements for persons exporting human drugs,
biological products, devices, animal drugs, food, and cosmetics that
may not be marketed or sold in the United States.

DATES: Submit either electronic or written comments on the collection
of information by February 4, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug

Administration, 1350 Piccard Dr., PI50-410B, Rockville, MD 20850, 301-
796-3794, E-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility, (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used, (3) ways to enhance the quality,
utility, and clarity of the information to be collected, and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Exports: Notification and Recordkeeping Requirements--21 CFR Part 1
(OMB Control Number 0910-0482)--Extension

    The respondents to this information collection are exporters who
have notified FDA of their intent to export unapproved products that
may not be sold or marketed in the United States as allowed under
section 801(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 381). In general, the notification identifies the
product being exported (e.g., name, description, and in some cases,
country of destination) and specifies where the notification should be
sent. These notifications are sent only for an initial export;
subsequent exports of the same product to the same destination (or, in
the case of certain countries identified in section 802(b) of the FD&C
Act (21 U.S.C. 382)) would not result in a notification to FDA.
    The recordkeepers for this information collection export human
drugs, biologics, devices, animal drugs, foods, and cosmetics that may
not be sold in the United States and maintain records demonstrating
their compliance with the requirements in section 801(e)(1) of the FD&C
Act.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual
                           21 CFR Section                               Number of      frequency per     Total annual      Hours per       Total hours
                                                                       respondents        response        responses         response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101 (d) to (e)...................................................             400                3            1,200               15           18,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual
                        21 CFR Section                              Number of       frequency per     Total annual    Hours per record     Total hours
                                                                  recordkeepers     recordkeeping        records
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101 (b) to (c)..............................................              320                 3               960                22            21,120
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: November 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30433 Filed 12-3-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Notices]
[Pages 27331-27332]
[FR Doc No: 2011-11532]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0272]

Draft Guidance for Industry and Food and Drug Administration
Staff; Establishing the Performance Characteristics of In Vitro
Diagnostic Devices for Chlamydia Trachomatis and/or Neisseria
Gonorrhoeae: Screening and Diagnostic Testing; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Establishing the
Performance Characteristics of In Vitro Diagnostic Devices for
Chlamydia Trachomatis and/or Neisseria Gonorrhoeae: Screening and
Diagnostic Testing.'' This draft guidance document provides industry
and Agency staff with recommendations for studies to establish the
analytical and clinical performance of in vitro diagnostic devices
(IVDs) intended for C. trachomatis and/or N. gonorrhoeae screening and
diagnostic testing using nucleic acid based assays. This draft guidance
is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 9, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Establishing the Performance
Characteristics of In Vitro Diagnostic Devices for Chlamydia
Trachomatis and/or Neisseria Gonorrhoeae: Screening and Diagnostic
Testing'' to the Division of Small Manufacturers, International, and
Consumer Assistance, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request, or fax your request to
301-847-8149. See the SUPPLEMENTARY INFORMATION section for information
on electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kathleen Whitaker, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5500, Silver Spring, MD 20993-0002, 301-
796-6208.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this draft guidance to provide industry and Agency
staff with recommendations for studies to establish the analytical and
clinical performance of IVDs intended for C. trachomatis and/or N.
gonorrhoeae screening and diagnostic testing using nucleic acid based
assays. These devices are used to aid in the diagnosis of urogenital C.
trachomatis and N. gonorrhoeae infection. They include devices that
detect one specific organism, as well as devices that may detect both
organisms with or without further differentiation.
    This draft guidance provides detailed information on the types of
studies FDA recommends to support class I and class II premarket
submissions for these devices. The draft guidance includes a list of C.
trachomatis and N. gonorrhoeae strains recommended for analytical
sensitivity studies and a list of micro-organisms recommended for
analytical specificity studies. This document also addresses
recommendations for fulfilling labeling requirements applicable to all
in vitro diagnostic devices intended to screen for, or aid in the
diagnosis of, C. trachomatis and/or N. gonorrhoeae directly from human
specimens.
    This document is limited to studies intended to establish the
performance characteristics of devices that detect chlamydial and/or
gonococcal nucleic acid. It does not address detection of serological
response from the host to bacterial antigens, nor does it address
establishing performance of non-chlamydial or non-gonococcal components
of multianalyte or multiplex devices.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on establishing
the performance characteristics of in vitro diagnostic devices for C.
trachomatis and/or N. gonorrhoeae screening and diagnostic testing. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statute
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Establishing the Performance Characteristics of In Vitro Diagnostic
Devices for Chlamydia Trachomatis and/or Neisseria Gonorrhoeae:
Screening and Diagnostic Testing,'' you may either send an e-mail
request to<EMAIL_ADDRESS>to receive an electronic copy of the
document or send a fax request to<PHONE_NUMBER> to receive a hard copy.
Please use the document number 1733 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations and guidance documents. 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
807, subpart E have been approved under OMB control number 0910-0120;
the collections of information in 21 CFR part 812 have been approved
under OMB control number 0910-0078; the collections of information in
21 CFR parts 56.115 have been approved under OMB control number 0910-
0130; and the collections of information in 21 CFR part 801 and 21 CFR
809.10 have been approved under OMB control number 0910-0485.

V. Comments

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

    Dated: May 6, 2011.
 Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-11532 Filed 5-10-11; 8:45 am]
BILLING CODE 4160-01-P