[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Rules and Regulations]
[Pages 63867-63868]
[FR Doc No: 2013-25205]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 73

[Docket No. FAA-2013-0771; Airspace Docket No. 13-ASW-18]
RIN 2120-AA66

Change of Using Agency for Restricted Areas R-5115, NM, and R-
6316, R-6317, and R-6318, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action updates the name of the using agencies for
Restricted Areas R-5115 in New Mexico and R-6316, R-6317, and R-6318 in
Texas at the request of the Department of the Air Force. This is an
administrative change only and does not affect the boundaries;
designated altitudes; times of designation; or activities conducted
within the affected restricted areas.

DATES: Effective date: 0901 UTC, December 12, 2013.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Policy and ATC
Procedures Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    As a result of the realignment of organizational responsibilities
between federal agencies, U.S. Customs and Border Protection has been
assigned the function of using agency for restricted areas R-5115 in
New Mexico; and R-6316, R-6317, and R-6318 in Texas. The transfer of
using agency operational control occurs October 1, 2013. This action is
an administrative name change only and does not affect the current
dimensions or use of the restricted areas.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 73 by amending the using agency name for Restricted Areas R-5115
Deming, NM; R-6316 Eagle Pass, TX; R-6317 El Sauz, TX; and R-6318
Marfa, TX. The using agency for R-5115, R-6316, R-6317, and R-6318 is
changed from ``Western Air Defense Sector'' to ``U.S. Customs and
Border Protection, Air and Marine Operations Center (AMOC), Riverside,
CA.''
    This is an administrative change to update the title of the using
agencies. It does not affect the boundaries, designated altitudes, or
activities conducted within the restricted areas; therefore, notice and
public procedure under 5 U.S.C. 553(b) are unnecessary.
    The FAA has determined that this action only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the descriptions of restricted areas R-5115, R-6316, R-
6317, and R-6318 to reflect current organizational responsibilities.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, Environmental Impacts: Policies and Procedures,
paragraph 311d. This airspace action is an administrative change to the
descriptions of the affected restricted areas to update the using
agency name. It does not alter the dimensions, altitudes, or times of
designation of the airspace; therefore, it is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exists that warrant preparation of an environmental
assessment.

List of Subjects in 14 CFR Part 73

    Airspace, Prohibited areas, Restricted areas.

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 73, as follows:

PART 73--SPECIAL USE AIRSPACE

0
1. The authority citation for part 73 continues to read as follows:

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

Sec.  73.51  [Amended]

0
2. Section 73.51 is amended as follows:
* * * * *

R-5115 Deming, NM [Amended]

    By removing the current using agency and substituting the
following:
    Using agency. U.S. Customs and Border Protection, Air and Marine
Operations Center (AMOC), Riverside, CA.

Sec.  73.63  [Amended]

0
3. Section 73.63 is amended as follows:
* * * * *

R-6316 Eagle Pass, TX [Amended]

    By removing the current using agency and substituting the
following:
    Using agency. U.S. Customs and Border Protection, Air and Marine
Operations Center (AMOC), Riverside, CA.

R-6317 El Sauz, TX [Amended]

    By removing the current using agency and substituting the
following:
    Using agency. U.S. Customs and Border Protection, Air and Marine
Operations Center (AMOC), Riverside, CA.

R-6318 Marfa, TX [Amended]

    By removing the current using agency and substituting the
following:
    Using agency. U.S. Customs and Border Protection, Air and Marine
Operations Center (AMOC), Riverside, CA.

    Issued in Washington, DC on October 21, 2013.
Gary A. Norek,
Manager, Airspace Policy and ATC Procedures Group.
[FR Doc. 2013-25205 Filed 10-24-13; 8:45 am]
BILLING CODE 4910-13-P


From: Owens, Willie<EMAIL_ADDRESS>
Sent: Wed 3/26/2008 11:42 AM

To: Charles Eldridge

Cc: Timm, Gary; Smith, Jane

Subject: Follow up on antiestrogen Question

Dear Charles -

Two relevant points to try and further address your question yesterday
about the antiestrogen....

Pls inform the EPA officers to ensure this communication is within their
rules and bounds.  I'm also cc'ing both Gary Timm and Jane Smith to
ensure this is transparent and, hopefully, above board.

1.		 The uterotrophic and Hershberger approaches to antagonists are
almost identical.

		 a.		 Step 1 or Phase1 as to run in multiple labs the dose response
curves for the reference positives, EE and TP, respectively.

		 b.		 Step 2 was to identify an approximate ED70 on those dose
response curves.  The rationale was basically in two parts:

   i.      Due to the significant magnitude of the changes in many
tissues such as the uterus, ventral prostate, seminal vesicles, and
Cowper's glands, the EC70 would provide adequate power for detection -
and with the rather low CVs of the solid tissues like the LABC and GP,
even with their lower response, adequate power would also be available.

   ii.      If we went higher than an ED70, due to the inherent
variability, some laboratories were likely to have reached a maximum on
the plateau with some risk that they would then be so "max'd" that some
insensitivity could result.

		 c.		 Step 3 was to test out the "hypothesis" - a pure antiestrogen,
ZM 189,154, and antiandrogen, Flutamide, respectively.  Two reference
doses and a dose response series for the antagonist.  Both worked
nicely.  This confirmed two key points in both cases: a) a positive
reference agonist dose adequate to test the laboratory and its
conditions was agreed and b) the dose of the antagonist to use for
testing the viability and performance of the antagonist assay was
agreed.

		 		 Willie's conclusion - at this point, all evidence is good as I
noted.  But, one can also do a very reasonable plausibility extension -
that is, the Hershberger antagonist assay worked like a charm (e.g., the
linuron data reproduction slide that I showed).  Given our knowledge of
the uterotrophic, there is simply nothing that argues against it not
working as well or even better.

    I mentioned in closing the very extensive Japanese data set that had
been built up for the uterotrophic.  What I forgot - and want to
communicate - the Japanese have performed BOTH the agonist and
antagonist assays - so THERE IS AN EXTENSIVE ANTAGONIST DATA SET.  AND
they have been rather careful to explore the relationships of the OECD
proposed assays in concert ... something the EPA proposal will effective
do for about 70 compounds.  I am attaching one of the publications where
the utero, H, and modified 407 are run in unison.  METI has released
their utero and H data sets within the OECD, but I am not sure that I
can release those to you.

	 a.	See Table 1.

	 b.	My observations are the 300+ sets of data that I have seen are:

       i.      If the chemical is negative on the agonist, the bulk of
the data are negative on the antagonist (as one would expect).

       ii.     If the chemical is positive on the agonist, there is
almost always a partial agonist-antagonist finding - that is, at the
dose where the agonist increase is observed - there is a parallel
decrease (absolute and statistically significant) at the same dose in
the antagonist assay.

       iii.    Together, these data would argue fairly persuasively that
the antagonist assay is valid.

       iv.     HOWEVER, as with the example and thus my deliberate
purpose - when the body weights are dropping 4-5% WITH THREE DAYS OF
ADMINISTRATION, SO VERY RAPID GIVEN THE SHORT DURATION - then one often
sees an absolute decline in the stimulated uterus.  So we have the very
difficult issue here as with the other assays - when do the overt
toxicities cause us to see confounding responses that are difficult to
interpret.

Willie's key communication and conclusion - there is a clear data set to
support the antiestrogen segment of the uterotrophic as valid with
indications of key limitations - there have been 3 labs as I understand
it involved in generating the Japanese data sets - and the tamoxifen
standard response would be available as with this Table to assess
reproducibility - but I DO NOT know if other test compounds have been
actually done in several labs to full support interlaboratory assessment
in a strict sense.

So I hope this helps - and hope that it is within EPA bounds.  No bad
intents here.

Best regards, Willie


[Federal Register Volume 86, Number 133 (Thursday, July 15, 2021)]
[Rules and Regulations]
[Pages 37219-37221]
[FR Doc No: 2021-15028]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-1030; Project Identifier AD-2020-01079-T;
Amendment 39-21607; AD 2021-13-02]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain The Boeing Company Model 777-300ER series airplanes. This AD
was prompted by a report that a production design change to certain
insulation blankets inadvertently opened up leakage paths for halon and
smoke to escape from the aft cargo compartment in the event of a fire.
This AD requires installation of an insulation blanket assembly on top
of existing insulation blankets in certain areas of the forward endwall
in the aft cargo compartment. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective August 19, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 19,
2021.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this service information at the
FAA, Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2020-1030.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-1030; 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 final rule, any
comments received, and other information. The address for Docket
Operations is U.S. Department of Transportation, Docket Operations, M-
30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Courtney Kronenberger, Aerospace
Engineer, Cabin Safety and Environmental Systems Section, FAA, Seattle
ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax:
206-231-3986; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain The Boeing
Company Model 777-300ER series airplanes. The NPRM published in the
Federal Register on December 29, 2020 (85 FR 85557). The NPRM was
prompted by report indicating that a production design change to
certain insulation blankets inadvertently opened up leakage paths for
halon and smoke to escape from the aft cargo compartment in the event
of a fire. In the NPRM, the FAA proposed to require installation of an
insulation blanket assembly on top of existing insulation blankets in
certain areas of the forward endwall in the aft cargo compartment. The
FAA is issuing this AD to address increased leakage paths, which, in
the event of a fire, could result in loss of fire suppressant in the
cargo compartment, and could lead to an uncontained fire and subsequent
loss of the airplane.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from one commenter, Boeing, who supported
the NPRM without change.
    The FAA received additional comments from one commenter, United
Airlines. The following presents the comments received on the NPRM and
the FAA's response to each comment.

Request for Update to Illustrated Parts Catalog (IPC)

    United Airlines stated that it agrees with the intent of the
proposed AD. United Airlines also recommended that Boeing update the
applicable IPC to show configuration control of the new part numbers
that are installed during the accomplishment of the actions specified
in the referenced service information. United Airlines noted that the
update would provide proper configuration control and documentation
support to maintain the new insulation blanket installation changes
made prior to the release of the AD. United Airlines also asserted that
the change could mitigate incorrect blanket installation.
    The FAA acknowledges the commenter's recommendation and reasoning.
However, the FAA does not control or require changes to the IPC. The
FAA has not changed this AD in this regard.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting this AD as
proposed. Except for minor editorial changes, this AD is adopted as
proposed in the NPRM. None of the changes will increase the economic
burden on any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Boeing Special Attention Requirements Bulletin
777-25-0753 RB, dated July 31, 2020. This service information specifies
procedures for installing an insulation blanket assembly on top of
existing insulation blankets on the left and right side corner of the
forward endwall in the aft cargo compartment. 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 ADDRESSES.

Costs of Compliance

    The FAA estimates that this AD affects 22 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Insulation blanket installation.......  1 work-hour x $85 per               $240            $325          $7,150
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected operators. The FAA does not control warranty coverage for
affected operators. As a result, the FAA has included all known costs
in the cost estimate.

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.

Regulatory Findings

    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) 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 Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES PROJECT NO. 15021-000

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] Project No. 15021-000

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

2021-13-02 The Boeing Company: Amendment 39-21607; Docket No. FAA-
2020-1030; Project Identifier AD-2020-01079-T.

(a) Effective Date

    This airworthiness directive (AD) is effective August 19, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 777-300ER series
airplanes, certificated in any category, as identified in Boeing
Special Attention Requirements Bulletin 777-25-0753 RB, dated July
31, 2020.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by a report that a production design change
to certain insulation blankets inadvertently opened up leakage paths
for halon and smoke to escape from the aft cargo compartment in the
event of a fire. The FAA is issuing this AD to address increased
leakage paths, which, in the event of a fire, could result in loss
of fire suppressant in the cargo compartment, and could lead to an
uncontained fire and subsequent loss of the airplane.

(f) Compliance

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

(g) Required Actions

    Except as specified by paragraph (h) of this AD: At the
applicable times specified in the ``Compliance'' paragraph of Boeing
Special Attention Requirements Bulletin 777-25-0753 RB, dated July
31, 2020, do all applicable actions identified in, and in accordance
with, the Accomplishment Instructions of Boeing Special Attention
Requirements Bulletin 777-25-0753 RB, dated July 31, 2020.
    Note 1 to paragraph (g): Guidance for accomplishing the actions
required by this AD can be found in Boeing Special Attention Service
Bulletin 777-25-0753, dated July 31, 2020, which is referred to in
Boeing Special Attention Requirements Bulletin 777-25-0753 RB, dated
July 31, 2020.

(h) Exceptions to Service Information Specifications

    Where Boeing Special Attention Requirements Bulletin 777-25-0753
RB, dated July 31, 2020, uses the phrase ``the original issue date
of the Requirements Bulletin 777-25-0753 RB,'' this AD requires
using ``the effective date of this AD.''

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO 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 responsible Flight Standards 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 (j)(1) of this AD. Information may be
emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, Seattle
ACO Branch, FAA, to make those findings. To be approved, the repair
method, modification deviation, or alteration deviation must meet
the certification basis of the airplane, and the approval must
specifically refer to this AD.

(j) Related Information

    (1) For more information about this AD, contact Courtney
Kronenberger, Aerospace Engineer, Cabin Safety and Environmental
Systems Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des
Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (k)(3) and (4) of this AD.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Special Attention Requirements Bulletin 777-25-0753
RB, dated July 31, 2020.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the

National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on June 9, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-15028 Filed 7-14-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 12, 2010 (Volume 75, Number 69)]
[Notices]
[Page 18509-18510]
[DOCID:fr12ap10-63]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0342]

International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 10 on
Polyacrylamide Gel Electrophoresis General Chapter; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the ICH Regions; Annex 10:
Polyacrylamide Gel Electrophoresis General Chapter.'' The guidance was
prepared under the auspices of the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The guidance provides the results
of the ICH Q4B evaluation of the Polyacrylamide Gel Electrophoresis
General Chapter harmonized text from each of the three pharmacopoeias
(United States, European, and Japanese) represented by the
Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition
of the three pharmacopoeial methods by the three ICH regulatory regions
and provides specific information regarding the recognition. The
guidance is intended to recognize the interchangeability between the
local regional pharmacopoeias, thus avoiding redundant testing in favor
of a common testing strategy in each regulatory region. In the Federal
Register of February 21, 2008 (73 FR 9575), FDA made available a
guidance on the Q4B process entitled ``Q4B Evaluation and

Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.''

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

ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information (HFD-240), Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448. The guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send two self-addressed adhesive labels to assist the office in
processing your requests. Submit written comments on the guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Robert H. King, Sr., Center for Drug
Evaluation and Research (HFD-003), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm. 4150, Silver Spring, MD 20993-0002,
301-796-1242; or
    Christopher Joneckis, Center for Biologics Evaluation and Research
(HFM-25), Food and Drug Administration, 1401 Rockville Pike, suite
200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of August 14, 2009 (74 FR 41143), FDA
published a notice announcing the availability of a draft tripartite
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex 10: Polyacrylamide Gel
Electrophoresis General Chapter.'' The notice gave interested persons
an opportunity to submit comments by October 13, 2009.
    After consideration of the comments received and revisions to the
guidance, a final draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 10: Polyacrylamide Gel Electrophoresis General Chapter'' was
submitted to the ICH Steering Committee and endorsed by the three
participating regulatory agencies in October 2009.
    The guidance provides the specific evaluation outcome from the ICH
Q4B process for the Polyacrylamide Gel Electrophoresis General Chapter
harmonization proposal originating from the three-party PDG. This
guidance is in the form of an annex to the core ICH Q4B guidance. When
implemented, the annex will provide guidance for industry and
regulators on the use of the specific pharmacopoeial texts evaluated by
the ICH Q4B process. Following receipt of comments on the draft, no
substantive changes were made to the annex.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on this topic. 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 statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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.

III. Electronic Access

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

    Dated: April 6, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8227 Filed 4-9-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 139 (Thursday, July 19, 2018)]
[Proposed Rules]
[Pages 34094-34096]
[FR Doc No: 2018-15353]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2018-0505; FRL-9981-01--Region 10]

Air Plan Approval; Oregon; Interstate Transport Requirements for
the 2012 PM2.5 NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Clean Air Act (CAA) requires each State Implementation
Plan (SIP) to contain adequate provisions prohibiting emissions that
will have certain adverse air quality effects in other states. On
October 20, 2015, the State of Oregon made a submission to the
Environmental Protection Agency (EPA) to address these requirements.
The EPA is proposing to approve the submission as meeting the
requirement that each SIP contain adequate provisions to prohibit
emissions that will contribute significantly to nonattainment or
interfere with maintenance of the 2012 annual fine particulate matter
(PM2.5) national ambient air quality standard (NAAQS) in any
other state.

DATES: Comments must be received on or before August 20, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2018-0505 at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be

edited or removed from Regulations.gov. The EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information the disclosure of which is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e. on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Jeff Hunt, Air Planning Unit, Office
of Air and Waste (OAW-150), Environmental Protection Agency, Region 10,
1200 Sixth Ave., Suite 155, Seattle, WA 98101; telephone number: (206)
553-0256; email address: [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean the EPA. This supplementary
information section is arranged as follows:

Table of Contents

I. What is the background of this SIP submission?
II. What guidance or information is the EPA using to evaluate this
SIP submission?
III. The EPA's Review
IV. What action is the EPA taking?
V. Statutory and Executive Order Reviews

I. What is the background of this SIP submission?

    This rulemaking addresses a submission from the Oregon Department
of Environmental Quality (ODEQ) assessing interstate transport
requirements for the 2012 annual PM2.5 NAAQS. The
requirement for states to make a SIP submission of this type arises
from section 110(a)(1) of the CAA. Pursuant to section 110(a)(1),
states must submit within 3 years (or such shorter period as the
Administrator may prescribe) after the promulgation of a national
primary ambient air quality standard (or any revision thereof), a plan
that provides for the implementation, maintenance, and enforcement of
such NAAQS. The statute directly imposes on states the duty to make
these SIP submissions, and the requirement to make the submissions is
not conditioned upon the EPA taking any action other than promulgating
a new or revised NAAQS. Section 110(a)(2) includes a list of specific
elements that ``[e]ach such plan'' submission must address. The EPA
commonly refers to such state plans as ``infrastructure SIPs.''
Specifically, this rulemaking addresses the requirements under CAA
section 110(a)(2)(D)(i)(I), otherwise known as the ``good neighbor''
provision, which requires SIPs to contain adequate provisions to
prohibit emissions that will contribute significantly to nonattainment
or interfere with maintenance of the NAAQS in any other state.

II. What guidance or information is the EPA using to evaluate this SIP
submission?

    The most recent relevant document was a memorandum published on
March 17, 2016, titled ``Information on the Interstate Transport ``Good
Neighbor'' Provision for the 2012 Fine Particulate Matter National
Ambient Air Quality Standards under Clean Air Act Section
110(a)(2)(D)(i)(I)'' (memorandum). The memorandum describes the EPA's
past approach to addressing interstate transport, and provides the
EPA's general review of relevant modeling data and air quality
projections as they relate to the 2012 annual PM2.5 NAAQS.
The memorandum provides information relevant to the EPA regional office
review of the CAA section 110(a)(2)(D)(i)(I) ``good neighbor''
provision in infrastructure SIPs with respect to the 2012 annual
PM2.5 NAAQS. This rulemaking considers information provided
in that memorandum.
    The memorandum also provides states and the EPA regional offices
with future year annual PM2.5 design values for monitors in
the United States based on quality assured and certified ambient
monitoring data and air quality modeling. The memorandum describes how
these projected potential design values can be used to help determine
which monitors should be further evaluated to potentially address
whether emissions from other states significantly contribute to
nonattainment or interfere with maintenance of the 2012 annual
PM2.5 NAAQS at those sites. The memorandum explains that the
pertinent year for evaluating air quality for purposes of addressing
interstate transport for the 2012 PM2.5 NAAQS is 2021, the
attainment deadline for 2012 PM2.5 NAAQS nonattainment areas
classified as Moderate.
    Based on this approach, the potential receptors are outlined in the
memorandum. Most of the potential receptors are in California, located
in the San Joaquin Valley or South Coast nonattainment areas. However,
there is also one potential receptor in Shoshone County, Idaho, and one
potential receptor in Allegheny County, Pennsylvania. The memorandum
also indicates that for certain states with incomplete ambient
monitoring data, additional information including the latest available
data should be analyzed to determine whether there are potential
downwind air quality problems that may be impacted by transported
emissions.
    This rulemaking considers analysis in Oregon's submission, as well
as additional analysis conducted by the EPA during review of its
submission. For more information on how we conducted our analysis,
please see the technical support document (TSD) included in the docket
for this action.

III. The EPA's Review

    This rulemaking proposes action on Oregon's October 20, 2015, SIP
submission addressing the good neighbor provision requirements of CAA
section 110(a)(2)(D)(i)(I). State plans must address specific
requirements of the good neighbor provisions (commonly referred to as
``prongs''), including:

--Prohibiting any source or other type of emissions activity in one
state from contributing significantly to nonattainment of the NAAQS in
another state (prong one); and
--Prohibiting any source or other type of emissions activity in one
state from interfering with maintenance of the NAAQS in another state
(prong two).

    The EPA has developed a consistent framework for addressing the
prong one and two interstate transport requirements with respect to the
PM2.5 NAAQS in several previous federal rulemakings. The
four basic steps of that framework include: (1) Identifying downwind
receptors that are expected to have problems attaining or maintaining
the relevant NAAQS; (2) identifying which upwind states contribute to
these identified problems in amounts sufficient to warrant further
review and analysis; (3) for states identified as contributing to
downwind air quality problems, identifying upwind emissions reductions
necessary to prevent an upwind state from significantly contributing to
nonattainment or interfering with

maintenance of the relevant NAAQS downwind; and (4) for states that are
found to have emissions that significantly contribute to nonattainment
or interfere with maintenance of the relevant NAAQS downwind, reducing
the identified upwind emissions through adoption of permanent and
enforceable measures. This framework was applied with respect to
PM2.5 in the Cross-State Air Pollution Rule (CSAPR),
designed to address both the 1997 and 2006 PM2.5 standards,
as well as the 1997 ozone standard.\1\
---------------------------------------------------------------------------

    \1\ Oregon was not part of the CSAPR rulemaking. The EPA
approved the Oregon SIP as meeting the CAA section
110(a)(2)(D)(i)(I) requirements for the 1997 ozone and 1997
PM2.5 NAAQS on June 9, 2011 (76 FR 33650) and the 2006
PM2.5 NAAQS on January 16, 2015 (80 FR 2313).
---------------------------------------------------------------------------

    In its submission, ODEQ reviewed air quality monitoring data for
several surrounding western states to identify potential downwind
receptors that may have problems attaining or maintaining the 2012
PM2.5 NAAQS. ODEQ then reviewed geographical distance,
topography, meteorology (local stagnation events), air monitoring
trends, industrial source emissions near the state border, and Western
Regional Air Partnership (WRAP) modeling to determine if emissions from
Oregon may impact these specific areas. From this analysis and
consultation with neighboring state air agencies, ODEQ concluded that
Oregon does not significantly contribute to nonattainment or interfere
with maintenance of the 2012 PM2.5 NAAQS in any other state.
    As discussed in the TSD for this action, we came to the same
conclusion as the state. In our evaluation, potential downwind
nonattainment and maintenance receptors were identified in other
states. The EPA evaluated these potential receptors to determine first
if, based on review of relevant data and other information, there would
be downwind nonattainment or maintenance problems, and if so, whether
Oregon contributes to such problems in these areas. After reviewing air
quality reports, modeling results, designation letters, designation
technical support documents, attainment plans and other information for
these areas, we find there is no contribution sufficient to warrant
additional SIP measures. Therefore, we are proposing to approve the
Oregon SIP as meeting CAA section 110(a)(2)(i)(I) interstate transport
requirements for the 2012 PM2.5 NAAQS.

IV. What action is the EPA taking?

    The EPA is proposing to approve ODEQ's October 20, 2015, submission
certifying that the Oregon SIP is sufficient to meet the interstate
transport requirements of CAA section 110(a)(2)(D)(i)(I), specifically
prongs one and two, as set forth above. The EPA is requesting comments
on the proposed approval.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Dated: July 3, 2018.
Chris Hladick,
Regional Administrator, Region 10.
[FR Doc. 2018-15353 Filed 7-18-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34633-34634]
[FR Doc No: 2015-14873]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 9100-036]

Riverdale Power and Electric Company, Inc.; Notice Soliciting
Applications

    On May 31, 2012, Riverdale Power and Electric Company, Inc.
(Riverdale or licensee) filed a Notice of Intent (NOI) to file an
application for an exemption from licensing for its Riverdale Mills
Project, No. 9100, pursuant to section 16.19(b) of the Commission's
regulations. The existing license for Project No. 9100 expires on May
31, 2017.
    The Riverdale Mills Project currently operates with a capacity of
150-kilowatts (kW); however, in its NOI, the licensee indicated that it
intends to increase capacity to 420 kW. The project is located on the
Blackstone River, in the town of Northbridge, Worcester County,
Massachusetts. The project does not occupy any federal lands.
    The principal project works consist of: (1) A 10-foot-high, 142-
foot-long dam with 6 bays containing stoplogs and flashboards with a
crest elevation of 262.35 feet above mean sea level; (2) an 11.8-acre
impoundment; (3) three sluiceways; (4) a 150-kilowatt turbine-generator
unit located in a mill building; (5) a 231-foot-long tailrace; and (6)
appurtenant facilities.
    Pursuant to section 16.20(c) of the Commission's regulations, an
existing licensee with a minor license not subject to sections 14 and
15 of the Federal Power Act must file an application for a subsequent
license at least 24 months prior to the expiration of the current
license. As stated above, Riverdale's NOI indicated it would be filing
an application for an exemption from licensing; however, it did not
file an application for a subsequent license or an application for
exemption from licensing for the Riverdale Mills Project by the May 31,
2015, deadline. Therefore, pursuant to section 16.24(b)(2) of the
Commission's regulations, Riverdale is prohibited from filing an
application either individually or in conjunction with other entities
for the Riverdale Mills Project.
    Pursuant to section 16.25 of the Commission's regulations, we are
soliciting applications from potential applicants other than the
existing licensee. Interested parties have 90 days from the date of
this notice to file a NOI to file an application for a subsequent
license or exemption from licensing. An application for subsequent
license or

exemption for the Riverdale Mills Project (No. 9100) must be filed
within 18 months of the date of filing the NOI.
    Questions concerning this notice should be directed to Dr. Nicholas
Palso at<PHONE_NUMBER> or<EMAIL_ADDRESS>
    Dated: June 11, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-14873 Filed 6-16-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 173 (Friday, September 8, 2017)]
[Notices]
[Page 42550]
[FR Doc No: 2017-19121]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR17-24-000]

Valero Energy Corporation; Valero Marketing and Supply Company;
Notice of Emergency Request for Temporary Waiver

    Take notice that on September 5, 2017, Valero Energy Corporation
and Valero Marketing and Supply Company, filed a request that the
Federal Energy Regulatory Commission (Commission), under its emergency
powers pursuant to section 1(15) of the Interstate Commerce Act, 49
U.S.C. App. 1(15), allow, or if necessary direct, Colonial Pipeline
Company to temporarily waive any and all RVP product specifications for
conventional and reformulated gasoline that are inconsistent with the
Environmental Protection Agency's August 31, 2017 Fuel Waiver, as more
fully explained in the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214. Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for review in the Commission's Public
Reference Room in Washington, DC. There is an eSubscription link on the
Web site that enables subscribers to receive email notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please email<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on September 7, 2017.

    Dated: September 5, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-19121 Filed 9-7-17; 8:45 am]
BILLING CODE 6717-01-P