[Federal Register: October 16, 2007 (Volume 72, Number 199)]
[Notices]
[Page 58658-58660]
[DOCID:fr16oc07-70]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Project No: P-803-087

Pacific Gas and Electric Company; Notice of Application Tendered
for Filing with the Commission and Establishing Procedural Schedule for
Licensing and Deadline for Submission of Final Amendments

 October 9, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: P-803-087.
    c. Date Filed: October 2, 2007.
    d. Applicant: Pacific Gas and Electric Company (PG&E).
    e. Name of Project: DeSabla-Centerville Hydroelectric Project.
    f. Location: The existing project is located on Butte Creek and the
West Branch Feather River in Butte County, California. The project
affects 145.7 acres of federal lands administered by the Lassen
National Forest, 2.1 acres of federal lands administered by the Plumas
National Forest, and 11.6 acres of federal lands administered by the
U.S. Bureau of Land Management.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Randal S. Livingston, Vice President-Power
Generation, Pacific Gas and Electric Company, P.O. Box 770000, Mail
Code: N11E, San Francisco, CA 94177; Telephone<PHONE_NUMBER>.
    i. FERC Contact: Aaron Liberty,<PHONE_NUMBER> or
<EMAIL_ADDRESS>
    j. This application is not ready for environmental analysis at this
time.
    k. Project Description: The existing DeSabla-Centerville
Hydroelectric Project is composed of three developments, including
Toadtown, DeSabla, and Centerville, and has a combined installed
capacity of 26,400 kilowatts (kW).
    The Toadtown development, which diverts water from the West Branch
Feather River, consists of the following constructed facilities: (1)
Round Valley Reservoir, a 98 acre reservoir with a gross storage
capacity of 1,700 acre-feet; (2) Round Valley dam, an earthfill dam,
29-feet high and 810-feet long; (3) a 40-foot wide overflow spillway;
(4) a 15-inch outlet pipe at the base of Round Valley dam, and manual
low level outlet valve; (5) Philbrook Reservoir, a 173 acre reservoir
with a gross storage capacity of 4,985 acre-feet; (6) Philbrook main
dam (located on Philbrook Creek), a compacted earthfill dam, 87-feet
high and 850-feet long; (7) Philbrook auxiliary dam (170 feet to the
right of the main dam), a compacted earthfill dam, 24-feet high and
470-feet long; (8) a 29.7-foot wide spillway with 5 flashboard bays;
(9) a 10.75-foot long and 14.75-foot wide spillway with a single,
manual radial gate; (10) a 33-inch diameter, 460-foot long outlet
conduit from Philbrook Reservoir; (11) a 17-foot high, 8-feet diameter
submerged vertical concrete intake, controlled by a 30-inch diameter
manual needle valve; (12) Hendricks Head Dam, a concrete gravity

dam, 15-feet high with an overflow spillway section 98-feet wide; (13)
a 8.66-mile long Hendricks Canal, composed mostly of earthen ditch with
several flume and tunnel sections, with a capacity of 125 cfs; (14)
feeder diversions from 4 creeks into Hendricks/Toadtown canal; (15) a
40-inch diameter, 1,556-foot long steel penstock; (16) Toadtown
Powerhouse, a 28 by 44 foot reinforced concrete building, with one
turbine-generator unit and a normal operating capacity of 1.5 MW; (17)
a 1500-foot long 12 kv tapline connecting Toadtown Powerhouse to a
distribution system; and (18) appurtenant facilities.
    The DeSabla development, which diverts water from upper Butte Creek
and uses the outflow of the Toadtown development, consists of the
following constructed facilities: (1) The 2.4-mile long Toadtown Canal,
an earthen canal with a capacity of 125 cfs; (2) Butte Creek Diversion
Dam, a 50-foot high, 100-foot long, concrete arch dam with an overflow
spillway; (3) a 11.4-mile long Butte Canal, composed of earthen berm
sections, gunited sections, tunnel sections, a siphon, and flume
sections, with a capacity of 91 cfs; (4) a 0.7-mile long canal that
combines Butte Canal with Toadtown Canal, with a capacity of 191 cfs;
(5) feeder diversions from 4 creeks that flow into Butte Canal (1 not
in use); (6) DeSabla Dam, a 50-foot high, 100-foot wide earthen
embankment with a spillway canal; (7) DeSabla Forebay, a 15 acre
reservoir with a gross storage capacity of 163 acre-feet (originally
188 acre-feet); (8) a 66-inch diameter, reduced to 42-inch diameter,
1.3-mile long steel penstock; and (9) DeSabla Powerhouse, a 26.5 by 41
foot reinforced concrete building, with one turbine generator unit and
a normal operating capacity of 18.5 MW; (10) a 0.25-mile long
transmission tapline connecting DeSabla Powerhouse to the 60kV Oro Fino
Tap Line; and (11) appurtenant facilities.
    The Centerville development, which diverts the flow of Butte Creek
downstream of the DeSabla development, consists of the following
constructed facilities: (1) The Upper Centerville Canal, that
originates at DeSabla Powerhouse and ends at Helltown Ravine (currently
carries a few cfs for local water uses and has not been used for power
generation for many years); (2) Lower Centerville Diversion Dam, a 12-
foot high, 72.5 foot-wide concrete arch dam with an overflow spillway;
(3) an 8-mile long Lower Centerville Canal, composed of earthen canal
and several flume sections, with a capacity of 183 cfs; (4) feeder
diversions from 3 creeks that flow into Lower Centerville Canal (all 3
no longer in use); (5) one 30-inch diameter and one 42-inch diameter,
reduced to 36-inch diameter, 2,559-foot long steel penstocks; (6)
Centerville Forebay, a 27 by 37 foot concrete header box with a
spillway channel; (7) Centerville Powerhouse, a 32 by 109 foot
reinforced concrete building, with two turbine-generator units and a
total normal operating capacity of 6.4 MW; and (8) appurtenant
facilities.
    PG&E operates the project primarily as a run-of-river system and
operates on a continuous basis, using the water supply available after
satisfaction of the minimum instream flow requirements. During the
winter and spring, base flows in the West Branch of the Feather River
and Butte Creek typically provide adequate flow for full operation of
the Project powerhouses. During the summer months, the available base
flow water is augmented by water releases from Round Valley and
Philbrook reservoirs. During the fall months, Project powerhouses are
operated at reduced capacities due to low stream flows.
    Water releases from Round Valley reservoir flow down the West
Branch Feather River, and water releases from Philbrook reservoir pass
down natural channels of Philbrook Creek and the West Branch Feather
River about 8 miles to Hendricks Head dam. Then water is conveyed in
the Hendricks canal, through Toadtown Powerhouse, then into the
Toadtown canal. From this point, the water is conveyed in the Butte
Creek canal to DeSabla Forebay then discharged into Butte Creek. Water
flow is then diverted into the Lower Centerville canal to the
Centerville header box, through the Centerville Powerhouse, and finally
discharged to Butte Creek.
    PG&E proposes to continue operating the Project with no change to
Project generation facilities or features other than adoption of
resource management measures and the deletion of five feeder
diversions.
    l. Locations of the Application: A copy of the application is
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using

the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. You may also register online at http://www.ferc.gov/esubscribenow.htm
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Procedural Schedule: The application will be processed according
to the following Hydro Licensing Schedule. Revisions to the schedule
may be made as appropriate.

------------------------------------------------------------------------
              Milestone                           Target date
------------------------------------------------------------------------
Tendering Notice.....................  October 9, 2007.
Remaining Study Results Due..........  February 15, 2008.
Notice of Acceptance / Notice of       March 17, 2008.
 Ready for Environmental Analysis.
Filing of recommendations,             May 16, 2008.
 preliminary terms and conditions,
 and fishway prescriptions.
Commission issues Draft EA...........  November 12, 2008.
Comments on Draft EA.................  December 12, 2008.
Modified terms and conditions........  February 10, 2009.
Commission issues Final EA...........  May 11, 2009.
------------------------------------------------------------------------

    o. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-20318 Filed 10-15-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 98 (Monday, May 21, 2012)]
[Rules and Regulations]
[Pages 29861-29863]
[FR Doc No: 2012-11954]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0141; Directorate Identifier 2011-NM-092-AD;
Amendment 39-17054; AD 2012-10-05]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes. This AD
was prompted by an in-flight failure of the hydraulic control panel,
which resulted in the absence of pressure and quantity indication of
the hydraulic system and accompanying alerts for ``hydraulic system 1
low quantity'' and ``hydraulic system 2 low quantity.'' This AD
requires implementing new abnormal procedures for hydraulics in the
airplane flight manual (AFM). We are issuing this AD to prevent loss of
control of the airplane due to incorrect hydraulic system failure
information being provided to the flightcrew, followed by application
of inappropriate procedures.

DATES: This AD becomes effective June 25, 2012.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 25,
2012.

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

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on February 14, 2012
(77 FR 8181). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    An in-flight failure of the hydraulic control panel resulted in
the absence of pressure and quantity indication of the hydraulic
system and accompanying alerts for ``hydraulic system 1 low
quantity'' and ``hydraulic system 2 low quantity''. The procedures
prescribed the shut-off of the engine driven hydraulic pumps,
resulting in complete absence of hydraulic pressure, which made it
impossible to hydraulically control the flight controls, including
the stabiliser. The status information contained in the procedures
for these alerts may give the false impression that the stabiliser
is still hydraulically controllable on one channel. The flight crew
regained control by using the alternate electrically powered
stabiliser control.
    A safety review revealed that a ``hydraulic system 1 and 2 low
quantity'' alert could give the right information, however this
alert is not available in the Flight Warning System. To solve this
problem, Fokker Services improved the Hydraulic 1(2) Low Quantity
Procedures in the Airplane Flight Manual (AFM).
    For the reasons described above, this [EASA] AD requires the
implementation of new abnormal procedures for hydraulics in the AFM.

The unsafe condition is possible loss of control of the airplane due to
incorrect hydraulic system failure information being provided to the
flightcrew, followed by application of inappropriate procedures. You
may obtain further information by examining the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (77 FR 8181, February 14,
2012) or on the determination of the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD

as proposed, except for minor editorial changes. We have determined
that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 8181, February 14, 2012) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 8181, February 14, 2012).

Costs of Compliance

    We estimate that this AD will affect about 4 products of U.S.
registry. We also estimate that it will take about 1 work-hour per
product to comply with the basic requirements of this AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this AD to the U.S. operators to be $340, or $85 per
product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (77 FR 8181, February 14,
2012), the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2012-10-05 Fokker Services B.V.: Amendment 39-17054. Docket No. FAA-
2012-0141; Directorate Identifier 2011-NM-092-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective June 25,
2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Fokker Services B.V. Model F.28 Mark 0070 and
0100 airplanes, certificated in any category, all serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 29, Hydraulic
power.

(e) Reason

    This AD was prompted by an in-flight failure of the hydraulic
control panel, which resulted in the absence of pressure and
quantity indication of the hydraulic system and accompanying alerts
for ``hydraulic system 1 low quantity'' and ``hydraulic system 2 low
quantity.'' We are issuing this AD to prevent loss of control of the
airplane due to incorrect hydraulic system failure information being
provided to the flightcrew, followed by application of inappropriate
procedures.

(f) Compliance

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

(g) Airplane Flight Manual (AFM) Revision

    Within 3 months after the effective date of this AD, revise the
Abnormal Procedures--Hydraulics section of the Fokker F.28 AFM by
incorporating the information specified in Fokker Manual Change
Notification--Operational Documentation (MCNO) MCNO-F100-057, dated
December 17, 2010, into the Abnormal Procedures--Hydraulics section
of the AFM.

    Note 1 to paragraph (g) of this AD: The actions required by
paragraph (g) of this AD may be done by inserting a copy of Fokker
MCNO MCNO-F100-057, dated December 17, 2010, into the Abnormal
Procedures--Hydraulics section of the Fokker F.28 AFM. When Fokker
MCNO MCNO-F100-057, dated December 17, 2010, has been included in
the general revisions of the AFM, the general revisions may be
inserted in the AFM, provided the relevant information in the
general revision is identical to that in Fokker MCNO MCNO-F100-057,
dated December 17, 2010, and that MCNO may be removed.

(h) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to Attn: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required

to assure the product is airworthy before it is returned to service.

(i) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA)
Airworthiness Directive 2011-0051, dated March 22, 2011; and Fokker
MCNO MCNO-F100-057, dated December 17, 2010; for related
information.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the following service
information under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise.
    (i) Fokker Manual Change Notification--Operational Documentation
MCNO-F100-057, dated December 17, 2010.
    (3) For service information identified in this AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 231, 2150
AE Nieuw-Vennep, the Netherlands; telephone +31 (0)252-627-350; fax
+31 (0)252-627-211; email
<EMAIL_ADDRESS>Internet http://www.myfokkerfleet.com.
    (4) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (5) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on May 9, 2012.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-11954 Filed 5-18-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Notices]
[Pages 42662-42664]
[FR Doc No: 2018-18214]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2896]

Osteoarthritis: Structural Endpoints for the Development of
Drugs, Devices, and Biological Products for Treatment; Draft Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Osteoarthritis: Structural Endpoints for the Development of Drugs,
Devices, and Biological Products for Treatment.'' The purpose of this
draft guidance is to assist sponsors who are developing drugs, devices,
or biological products to treat the underlying pathophysiology and
structural progression of osteoarthritis (OA). This draft guidance does
not address improvement of symptoms of OA, such as pain or

functional impairment, which will be addressed in future guidances.

DATES: Submit either electronic or written comments on the draft
guidance by October 22, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-2896 for ``Osteoarthritis: Structural Endpoints for the
Development of Drugs, Devices, and Biological Products for Treatment.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
Office of the Center Director, Guidance and Policy Development, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Nikolay Nikolov, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3202, Silver Spring, MD 20993-0002, 301-
796-5281; Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Sahar Dawisha,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm, 5536, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Osteoarthritis: Structural Endpoints for the Development of
Drugs, Devices, and Biological Products for Treatment.'' The purpose of
this draft guidance is to assist sponsors who are developing drugs,
devices, or biological products to treat the underlying pathophysiology
and structural progression of OA. This guidance does not address
improvement of symptoms of OA, such as pain or functional impairment.
FDA recognizes the importance of these outcomes, which will be
addressed in future guidances. The previous draft guidance for industry
entitled ``Clinical Development Programs for Drugs, Devices, and
Biological Products Intended for the Treatment of Osteoarthritis
(OA),'' published July 15, 1999, has been withdrawn.
    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 current thinking of FDA on
``Osteoarthritis: Structural Endpoints for the Development of Drugs,
Devices, and Biological Products for Treatment.'' It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov.

    Dated: August 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18214 Filed 8-22-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Notices]
[Pages 37617-37618]
[FR Doc No: 2015-16228]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2003-0004; FRL-9929-26]

Access to Confidential Business Information by Vision
Technologies, Inc., and Its Identified Subcontractor, Computer Sciences
Corporation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has authorized its contractor, Vision Technologies, Inc.,
of Glen Burnie, MD, and Computer Sciences Corporation (CSC) of Falls
Church, VA, its identified subcontractor to access information which
has been submitted to EPA under all sections of the Toxic Substances
Control Act (TSCA). Some of the information may be claimed or
determined to be Confidential Business Information (CBI).

DATES: Access to the confidential data will occur no sooner than July
8, 2015.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Scott Sherlock, Environmental Assistance Division (7408M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8257; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; 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. This action may,
however, be of interest to all who manufacture, process, or distribute
industrial chemicals. Since other entities may also be interested, the
Agency has not attempted to describe all the specific entities that may
be affected by this action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPPT-2003-0004 is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics
Docket (OPPT Docket), Environmental Protection Agency Docket Center
(EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington,

DC. The 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
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
OPPT Docket is<PHONE_NUMBER>. Please review the visitor instructions
and additional information about the docket available at http://www.epa.gov/dockets.

II. What action is the agency taking?

    Under EPA contract number GS-06F-0535Z, order number 0015,
contractor Vision Technologies, Inc., of 530 McCormick Drive, Suite 6,
Glen Burnie, MD, and CSC, 3170 Fairview Park Drive, Falls Church, VA,
will assist EPA's Office of Research and Development by supporting the
desktop systems on which the CBI will reside. The contractor will also
provide information technology support and solutions to enhance science
and research results.
    In accordance with 40 CFR 2.306(j), EPA has determined that under
EPA contract number GS-06F-0535Z, order number 0015, Vision
Technologies and CSC will require access to CBI submitted to EPA under
all sections of TSCA to perform successfully the duties specified under
the contract. Vision Technologies and CSC personnel will be given
access to information submitted to EPA under all sections of TSCA. Some
of the information may be claimed or determined to be CBI.
    EPA is issuing this notice to inform all submitters of information
under all sections of TSCA that EPA may provide Vision Technologies and
CSC access to these CBI materials on a need-to-know basis only. All
access to TSCA CBI under this contract will take place at EPA
Headquarters in accordance with TSCA CBI Protection Manual.
    Access to TSCA data, including CBI, will continue until October 21,
2016. If the contract is extended, this access will also continue for
the duration of the extended contract without further notice.
    Vision Technologies and CSC personnel will be required to sign
nondisclosure agreements and will be briefed on appropriate security
procedures before they are permitted access to TSCA CBI.

    Authority:  15 U.S.C. 2601 et seq.

    Dated: June 19, 2015.
Pamela S. Myrick,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2015-16228 Filed 6-30-15; 8:45 am]
BILLING CODE 6560-50-P