and CBP recommend that FDA timeframes for imported food arriving by air and land be reduced
and be consistent with those set forth by CBP in their advanced electronic information rule.  No
comments recommend aligning the prior notice timeframe for imported food arriving by water
with the CBP advanced electronic information rule timeframe of 24 hours prior to loading on the
vessel.  The reasons for recommending that prior notice timeframes be the same as CBP’s
advanced electronic information timeframes for food arriving by air and land are that it would
minimize the complexity of the process by presenting a more streamlined flow of information
and avoid unnecessary duplication, result in fewer errors, provide better compliance rates, allow
for fewer disruptions at the border, significantly reduce the burden on the trade community
without creating additional security risks, and allow operators at close border points to load and
verify truck loads and travel routes prior to submitting notice. One comment suggested that there
is no basis for concluding that more time is needed for food shipments than for other shipments.

122
Another comment states that utilizing one system and one set of timelines should provide
adequate notice to FDA and improve compliance with the prior notice requirements.
(Response) The timeframes established in the final rule represent the minimum amount of
time FDA needs to meet our statutory responsibility to receive, review, and respond to prior
notice submissions.  In accordance with our Joint Implementation Plan, we evaluated the
feasibility of conducting prior notice reviews in a reduced time period in an effort to more
closely harmonize the submissions with CBP timeframes.  As part of our assessment, we
analyzed data regarding prior notices we received in the first 9.75 months of fiscal year (FY)
2005--specifically from prior notices received and responded to by the PNC between October 1,
2004, and July 23, 2005.  Based on the results of our assessment, in the final rule we have
maintained the timeframes that are in the IFR:
•
If the article of food is arriving by land by road, no less than 2 hours before arriving at the
port of arrival;
•
If the article of food is arriving by land by rail, no less than 4 hours before arriving at the
port of arrival;
•
If the article of food is arriving by air, no less than 4 hours before arriving at the port of
arrival; and
•
If the article of food is arriving by water, no less than 8 hours before arriving at the port
of arrival.
FDA and CBP established these timeframes for the IFR based on the information
available at the time.  By necessity, though, these decisions regarding timeframes were not
informed by actual experience in operating the prior notice program.  We now have that
experience, and the information gained during our assessment shows that the minimum

123
timeframes for submitting prior notices contained in the IFR closely match the minimum time
necessary for FDA to receive, review, and respond to the prior notices.  During the assessment
period, FDA was able to receive, review, and respond to almost all notices within the established
timeframes.  In a relatively small number of situations, FDA was not able to make a decision
regarding whether to inspect the food at the port of arrival by the end of the timeframe.  In these
situations, when the food arrived at the port of arrival, it was delayed while FDA completed its
review.  The number of such shipments, however, has been relatively low, and the resulting
impact on government resources and the flow of traffic at ports has not been significant.  Thus,
we do not believe we should increase the timeframes to account for this relatively small number
of outliers whose review takes longer than the IFR’s timeframes.
Our assessment also shows that, because the IFR's timeframes closely match the
minimum time necessary for FDA to receive, review, and respond to the prior notices, those
timeframes could not be significantly reduced.  If we were to change the timeframes to be
consistent with those of CBP's advance electronic information rule, not only would this go
against the statutory standard for setting the timeframes, but it would also significantly increase
the number of shipments where FDA would not be able to decide whether it should examine the
food at the port of arrival by the end of the timeframe.  Such shipments would be delayed at the
port of arrival until FDA has either completed its review or decided to examine or not examine
the food at the port or arrival without the benefit of a complete review.  The prior notice review
process, information from our assessment, and the consequences of reducing the timeframes for
conducting the prior notice review are discussed in more detail below.
To implement the Prior Notice IFR, FDA established the PNC that operates 24 hours a
day, 7 days a week, all days of the year to receive, review, and adequately responds to these

124
notices as they are submitted.  PNC staff is also responsible for responding in real-time (by e-
mail, fax, or telephone) to inquiries they receive from affected parties about pending prior
notices and/or operational issues.
The purpose of prior notice is to help identify food that potentially poses a significant
health risk to the American public and to deploy resources to the port of arrival so that
inspections can be conducted before the shipment ever enters the United States.  Regardless of
whether a prior notice is submitted electronically to FDA through CBP’s ABI/ACS or FDA’s
PNSI, the prior notice information undergoes a validation process and is then screened against
food safety and security criteria.
If the results of our initial validation indicate that the prior notice requirements have been
met and the results of our screening indicate that the shipment does not appear to be a potential
bioterrorism or significant public health threat, the submission is considered to have satisfied
prior notice requirements and the associated article of food is allowed to proceed for further
processing, including FDA admissibility review under section 801(a) of the act.  Alternatively, if
the results of the initial screening of the prior notice information indicate there is a potential
bioterrorism or other significant public health threat, the prior notice undergoes additional
intensive review by the PNC using other databases and sources of information to determine
whether the article of food should be held at the port of arrival for examination or should be
allowed to proceed into 801(a) status for admissibility review.  PNC personnel make this
determination using their experience with imported foods and the expertise within FDA’s
CFSAN for human food or FDA’s CVM for animal feed, the inspectional information obtained
by FDA’s ORA, and the expertise of CBP.  FDA's goal is to complete its review within the 2, 4,
or 8 hour timeframe for submitting prior notice so that the review is complete before the

125
shipment arrives at the port of arrival.  If the intensive review takes longer than the timeframe
and the shipment arrives at the port of arrival, then FDA may delay the shipment at the port of
arrival until its review is completed.
FDA receives approximately 167,000 prior notices each week.  The distribution of prior
notices by mode of transportation during our assessment that were flagged by the initial
screening and that received an intensive prior notice review by the PNC is as follows:
TABLE 1.--PROPORTION OF PRIOR NOTICES FLAGGED AT THE INITIAL SCREENING, BY MODE OF
TRANSPORTATION
Truck
27
.6
%
Car
2.
9%
Air
17
.6
%
Rail
0.
8%
Sea
39
.2
%
Mail
11
.1
%
Other
0.
8%
As indicated, a significant portion (approximately 31 percent) of the prior notices
reviewed by the PNC on a daily basis are land/road border entries, which under the IFR are
subject to submission timeframes of at least 2 hours before arrival.  On average, during the
assessment period, the PNC conducted intensive security reviews on 225 to 250 prior notices per
day from all modes of transportation, which means that, on average, the PNC conducted
intensive security reviews on about 77 prior notices (31 percent of 250) each day that are subject
to the 2-hour timeframe.  Moreover, the prior notices are not evenly distributed over an 8 hour
shift or 24-hour day.  The actual dispersal pattern of the prior notice submissions is not uniform;
an overwhelming majority of prior notice submissions arrive between a certain 12-hour period.
The amount of time the PNC has needed for its intensive review has ranged from 20
minutes to 315 minutes (5 hours and 25 minutes) from when FDA received the prior notice and
confirmed it for review.  Using data collected on articles of food arriving by land via truck and

126
car during our assessment period, the PNC expended an average of 61 minutes to receive,
review, and make a decision on whether or not a shipment should be refused or held for
examination under section 801(m) of the act, or allowed to proceed into 801 (a) status for
admissibility review.  The PNC completed about 99 percent of its intensive reviews of prior
notices submitted for land/road border arrivals within 120 minutes of receiving and confirming
the prior notice for review.  Only about 57 percent of the intensive reviews were completed
within 1 hour.  Reviews for the remaining 43 percent  (8,900 prior notices for the assessment
period, or more than 10,000 for FY 2005) took longer. If the timeframe were set at 1 hour for
these articles of food instead of the IFR's 2 hours, the PNC would have had to either delay the
food at the port of arrival until it completed its review or decide whether to examine the food at
the port or arrival without the benefit of a complete review.
FDA does not have data to accurately analyze the impact of changing the timeframe to 30
minutes for FAST participants because FAST membership is not one of the data elements that
we currently require in a prior notice submission.   FDA instead did the analysis based on the
total number of prior notices submitted that the PNC could review based on a timeframe of 30
minutes.  The PNC completed less than 10 percent of its intensive reviews of prior notices
submitted for land/road border arrivals within 30 minutes of receiving and confirming the prior
notice for review.  If the timeframe for all articles of food arriving by land by truck and car
during our assessment period had been 30 minutes (i.e., the timeframes for FAST participants)
instead of 2 hours, the PNC would not have completed approximately 68 percent of its intensive
reviews (over 14,000 during the assessment period, which equates to approximately 16,000 for
FY 2005 of the land/road border prior notices) within the applicable timeframe.  As a result, the
PNC would have had to either delay the food at the port of arrival until it completed its review or

127
decide whether to examine the food at the port of arrival without the benefit of a complete
review.  This assessment is an overestimate of the number of articles of food that would be
eligible for FAST timeframes, as we do not know how many articles of food arriving in the
United States subject to the prior notice requirements are from FAST and C-TPAT participants.
Moreover, there are other impediments to integrating prior notice with the C-TPAT and FAST
programs.  These are discussed in section III.D.6 of this document (“Additional Exclusions
Requested--Special Programs (C-TPAT/FAST) and Flexible Alternatives”).
We also conducted a similar assessment on prior notices submitted for articles of food
arriving by air between October 1, 2004, and July 23, 2005.  The IFR requires prior notices for
these shipments to be submitted and confirmed for review at least 4 hours before the food arrives
at the U.S. port of arrival.  If the timeframes for articles of food arriving by air during our
assessment period had been reduced to “wheels up,” the PNC would not have completed
approximately 21 percent of the intensive prior notice reviews for articles of food with flight
times less than three hours.  These articles of food (2,700 for our assessment period, or an
estimated 3,230 for FY 2005) also would have been subject to cargo delays and/or increased
cargo examinations.
Neither FDA nor CBP have sufficient personnel or resources to accommodate the number
of additional cargo delays and/or food shipment examinations that would result under either 60-
or 30-minute timeframes for articles of food arriving by land by road.  This would include the
significant additional personnel and resources needed to track, facilitate, and coordinate the
evaluation and/or examination of the delayed cargo.  Coordination of the handling of delayed
shipments is a resource intensive process that can last for multiple days per shipment, and

128
includes communicating with both FDA and CBP personnel at the border, and the brokers/filers
and importers involved in the shipment.
To handle the extra work, the PNC would need to shift its personnel, resulting in fewer
staff being available to review prior notices for all categories of shipments including shipments
arriving by water.  The PNC’s current approximate average time for the PNC intensive review
for shipments arriving by water is 5 hours, which is within the 8 hour submission timeframe.  We
would expect, based on our assessment, that the time taken away from prior notice review work
for the increase in coordination due to the increase in delays and examinations for land and air
shipments would increase the time needed to complete intensive review of prior notices for
shipments arriving by water by 25 percent at the minimum.   As a result, over 7,000 shipments
by water during our assessment period (estimated as 7,370 for FY 2005) would have been
delayed at the port of arrival while the PNC completed its intensive review and determined
whether the shipment in fact presented a significant health threat.
In setting the timeframes, the act provides that we may consider, among other
considerations, the effect on commerce (section 801(m)(2)(A) of the act).  Lowering the
timeframes to 60 or 30 minutes would likely result in delays at the border, not only for those
shipments delayed for intensive review longer than the timeframe, but also for other shipments
passing through the port, especially at the busiest land border ports where traffic lanes, parking,
and inspection facilities are extremely limited.  In some ports, the lack of holding facilities could
result in an increase in trucks being turned around at the border.
Thus, based on current and projected resources and other high-priority activities FDA is
addressing, reducing the timeframes would lead to an increase in delays at the ports of arrival,
causing FDA to shift some resources away from conducting intensive reviews of prior notices so

129
they can conduct the coordination and other activities necessary for these delayed shipments.
The shift in resources away from conducting intensive reviews would, in turn, further increase
the number of shipments that are delayed because FDA has not been able to finish its intensive
review within the applicable submission timeframe.    This ultimately would cause a delay in
getting cargo to its final destination, which would have an adverse impact on trade.
Moreover, the number of prior notices identified for intensive review has increased over
time, as intelligence and other risks are identified. We expect the number of intensive reviews to
continue to increase relative to the assessment period, resulting in even more food shipments that
would be delayed or held for examination under shortened timeframes.
We did not get any comments asking us to coordinate the timeframes for articles of food
arriving by water in our prior notice rule (8 hours before arrival) with those in CBP’s rule (24
hours before arrival).  We received one comment asking us to reduce the time for articles
arriving by water.  We stated in the preamble to the IFR “In determining the actual timeframes
for submission of prior notice for each mode of transportation, FDA considered the need to
provide sufficient time for the agency to review and respond to the information submitted, as
well as the current ability of the food industry to provide the information required within the
stated timeframe given the differences in lead time before arrival among different modes of
transportation. We determined that information for shipments whose transport time is measured
in days or weeks (e.g., ocean shipments) is available further in advance of arrival than shipments
whose transport time is measured in hours (e.g., land and air shipments.) Staggered prior notice
submission timeframes will allow FDA reviewers to direct additional resources to shipments
with short transport times and to defer review of shipments with longer transport times. Based on
these considerations, FDA established the prior notice timeframes in the interim final rule to

130
associate with the mode of transportation.” (69 FR at 58995).  We continue to hold this view for
shipments arriving by water in light of our assessment for articles of food arriving by land and
air.
For all of the previously stated reasons, we did not reduce the timeframes for submitting
prior notice in the final rule for any mode of transportation, as these timeframes still are the
minimum amount of time FDA needs to fulfill its statutory obligation to receive, review and
respond to prior notices while having the minimal impact on trade.
(Comments) One comment suggests that it would be preferable for FDA to harmonize the
prior notice timelines to the future ACE transmission timelines, ensuring consistency and
compliance of the trade community and efficiencies in both agency and industry workforces.
(Response) FDA agrees that timeframes for submission of prior notice may be further
evaluated in light of new trade programs such as ACE, when it is implemented and in effect.
CBP is planning to bring its ACE system on line in the next few years, which will accommodate
prior notice submissions and eliminate or change ABI/ACS and PNSI prior notice submissions.
FDA will continue to assess and pursue the integration of timeframes as policies, processes, and
strategic IT systems are improved.  FDA believes that the most opportune time for coordinating
timeframes will coincide with the startup of CBP’s ACE.  We will determine at that time or after
ACE is operational whether the prior notice timeframes should and can be reduced further.  Until
that time, the timeframes for submission of prior notice will remain the same in the final rule as
issued under the IFR (see § 1.279).
3. Phase-In of FDA and CBP Timeframes
When FDA reopened the comment period for the IFR on April 14, 2004 (see 69 FR
19763), FDA asked Flexible Alternative Question 6: “If FDA adopts reduced timeframes in the

131
prior notice final rule, should FDA phase in the shorter timeframes as CBP phases in the advance
electronic information rule?”
(Comments) Most comments recommend integration of the phase-in of reduced
timeframes in association with CBP’s schedule to promote consistency between the programs,
reduce errors, and minimize disruption of supply chains through conflicting requirements.
However, one comment, in addition to recommending adherence to CBP’s phase-in schedule,
also notes that they would not want FDA to delay adopting a reduced timeframe for submitting
prior notice merely because CBP is not yet ready to implement the counterpart provisions of its
advance notice programs.  In addition, they state that the deadlines are minimum periods, and
any shipper can provide more notice of imports, to FDA, CBP or both, than the minimum
timeframes in either regulation.  They recommend that FDA should shorten its lead times to
match those in the CBP regulations, even if the CBP requirements are not yet in place.  Another
comment states that the phase-in plan, which is a port-by-port implementation according to a
time schedule, would be very problematic to industry.  The comment further explains that
systems and operations do not necessarily have the flexibility to switch on by individual site or
location and the current plan would introduce complication and confuse the trade community.
The comment recommends further discussion with CBP and FDA as to development of a more
viable and achievable implementation plan.
(Response) This issue is moot, as the final rule retains the timeframes established in the
IFR, for the previously stated reasons.
4. Prior Notice Confirmation Number
(Comments) One comment asks for clarification regarding when the prior notice
confirmation number is required to accompany the food.

132
(Response) The prior notice confirmation number must accompany any article of food
arriving by international mail, when the food is carried by or otherwise accompanying an
individual, or when the prior notice was submitted via FDA’s PNSI.
Under § 1.279(e), the prior notice confirmation number must accompany any article of
food arriving by international mail.  Under § 1.279(f), a copy of the confirmation (with the prior
notice confirmation number) must accompany any article of food carried by or otherwise
accompanying an individual (unless excluded under § 1.277 (b)(1)), and be provided to CBP or
FDA upon arrival.  Additionally, under § 1.279(g) the prior notice confirmation number must
accompany any article of food for which the prior notice was submitted through the FDA PNSI
when arriving in the United States and must be provided to CBP and FDA upon arrival.
(Comments) One comment asked FDA to confirm whether it is sufficient for an ocean
carrier to have the prior notice confirmation number on arrival or whether they are required to
have the actual prior notice confirmation also.
(Response) Under § 1.279(e), the prior notice confirmation number must accompany any
article of food arriving by international mail.  Additionally, under § 1.279(g) the prior notice
confirmation number must accompany any article of food for which the prior notice was
submitted through the FDA PNSI when arriving in the United States and must be provided to
CBP and FDA upon arrival.  Therefore, although a prior notice confirmation number is required,
the final rule does not require that the actual prior notice confirmation has to be supplied for food
arriving by ocean carrier.
(Comments) One comment states that when food arrives in the United States, the carrier
should present a copy of the prior notice confirmation and the food to CBP.  The comment asks

133
if the submitter should send the prior notice confirmation to the carrier company or to the vessel
that transported the food to the United States.
(Response) As stated previously, § 1.279(e) requires the prior notice confirmation
number to accompany any article of food arriving by international mail. Additionally, under §
1.279(g) the prior notice confirmation number must accompany any article of food for which the
prior notice was submitted through the FDA PNSI when arriving in the United States and must
be provided to CBP and FDA upon arrival.  How persons importing or offering for import food
into the United States choose to comply with this requirement is a private matter (e.g., persons
may decide to specify these obligations in the contract between the exporting company and the
carriers to ensure that the logistics are worked out in advance).
(Comments) Comments stated that the data requirements should be reassessed to simplify
and make the requirements more manageable.  The comment states that one data element should
link all information secured by prior notice, which would be beneficial for locating shipments in
the event of a possible crisis.  The comments suggest that FDA use bill of lading numbers as a
single reference point because all shipments that are moved are repeatedly covered by this
number.  This would render the prior notice confirmation number currently used redundant.
(Response) FDA does not agree that the waybill/Bill of Lading can be used as a single
reference point for all shipments instead of the prior notice confirmation number.  A Bill of
Lading number is not always assigned to a shipment at the time of prior notice submission.  For
certain shipments, such as those sent by international mail, no Bill of Lading may exist.  Thus,
FDA has determined that it is better to use a unique confirmation number provided by the FDA
system to transmitters.

134
(Comments) One comment notes that a separate prior notice is required for each distinct
food product and a prior notice confirmation number is returned for each prior notice. Therefore,
if a shipment consists of multiple food products, the carrier would have multiple prior notice
confirmations upon arrival.  The comment states multiple prior notice confirmations do not align
well with the commercial realities of international trade, where the focus is on the entire
shipment, not the individual components.  The comment recommends that FDA provide a prior
notice confirmation number that encompasses the entire shipment.
(Response) FDA disagrees.  The carrier could be carrying articles of food for different
submitters or recipients.  If it was necessary to hold an article of food, the entire shipment would
be held under the above scenario suggested by the comment.  Under the final rule, the article of
food that is subject to a hold can be offloaded and the rest of the shipment allowed to proceed.
This would not be the case if there was only one prior notice confirmation number for the entire
shipment.
5. 5-day Maximum Pre-Arrival Limitation
(Comments) Many comments requested that prior notice be allowed to be submitted more
than 5 days before arrival.  This would allow exporters to complete their documentation at the
same time the bill of lading and health certification is usually completed in the case of food
shipped by water.  One comment contends that the 5 day limit does not reflect the variable and
unpredictable nature of transport and does not reflect a risk-based approach to a potential
bioterrorism threat.  Another comment contends that the limitation of the timeframe to 5 days is
problematic and is due to a misinterpretation of the statute.  The comment asserts that the
statutory language does not preclude a party from voluntarily providing prior notice more than 5
days in advance.  The comment also maintains that 10 days prior to arrival would provide the

135
necessary flexibility for their industry.  A foreign government, apparently assuming that prior
notice must be submitted by the foreign shipper or exporter, recommends that the time should be
extended because it may take the shipment 2 weeks to reach a U.S. port.
(Response) In response to the concerns raised by the comments, we have revised §
1.279(b) to allow submission of prior notice more than 5 days before arrival (except for articles
of food imported or offered for import by international mail).  Specifically, this provision permits
prior notice submissions to be submitted no more than 30 calendar days before the anticipated
date of arrival for submissions made through ABI/ACS and no more than 15 calendar days
before the anticipated date of arrival for submissions made through PNSI.  Due to system
limitations, the timeframes between ABI/ACS and PNSI are not identical. Also, because of the
way ABI/ACS is programmed, when prior notice is submitted through ABI/ACS, the prior notice
confirmation number cannot be provided more than 5 calendar days before the anticipated date
of arrival.
Please note that if any of the prior notice information, except the anticipated arrival
information, the estimated quantity, or the planned shipment information, changes after FDA has
confirmed the prior notice submission for review, the prior notice must be resubmitted, as
provided by § 1.282(a).  The resubmission must be confirmed by FDA for review no less than 2,
4, or 8 hours before arriving at the port of arrival, with the minimum time depending on the
mode of transportation (§ 1.279(a)).  If prior notice is resubmitted, the previous prior notice
should be cancelled (§ 1.282(b), (c)).
6. International Mail
(Comments) There were no comments received regarding the timeframes established for
prior notice covering food arriving by international mail.

136
(Response) FDA retained the timeframes for submission of prior notice for food arriving
by international mail that are in the IFR.
(Final rule) The final rule at § 1.279(a) requires that you must submit prior notice to FDA
and the prior notice submission must be confirmed by FDA for review as follows: If the article
of food is arriving by land by road, no less than 2 hours before arriving at the port of arrival; if
the article of food is arriving by land by rail, no less than 4 hours before arriving at the port of
arrival; if the article of food is arriving by air, no less than 4 hours before arriving at the port of
arrival; or if the article of food is arriving by water, no less than 8 hours before arriving at the
port of arrival.
Under § 1.279(b), except in the case of an article of food imported or offered for import
by international mail, prior notice may be submitted no more than 30 calendar days before the
anticipated date of arrival for submissions made through ABI/ACS and no more than 15 calendar
days before the anticipated date of arrival for submissions made through PNSI.
Under § 1.279(c), if the article of food is arriving by international mail, the prior notice
must be submitted before the article of food is sent to the United States.
Under § 1.279(d), FDA will provide notification that the prior notice has been confirmed
for review with a reply message that contains a prior notice confirmation number.  The prior
notice will be considered submitted and the prior notice review time will start when FDA has
confirmed the prior notice for review.
Under § 1.279(e), the prior notice confirmation number must accompany any article of
food arriving by international mail.  The prior notice confirmation number must appear on the
Customs Declaration that accompanies the package.  We provide CN22 or CN23 or a U.S.
equivalent as examples of the Customs Declaration.

137
Under § 1.279(f), a copy of the confirmation, including the prior notice confirmation
number, must accompany any article of food that is subject to this subpart when it is carried by
or otherwise accompanies an individual when arriving in the United States.  The copy of the
confirmation must be provided to CBP or FDA upon arrival.
Under § 1.279(g), the prior notice confirmation number must accompany any article of
food for which the prior notice was submitted through the FDA PNSI when the article arrives in
the United States and must be provided to CBP or FDA upon arrival.
G. How Must You Submit the Prior Notice? (§ 1.280)
Section 1.280 of the IFR required that prior notice must be submitted electronically to
FDA in the English language, except that an individual’s name, the name of a company, and the
name of a street may be submitted in a foreign language.  All information, including these items,
must be submitted using the Latin (Roman) alphabet.  The IFR provided for two methods of
electronic submission of prior notice: (1) The CBP ABI/ACS; or (2) FDA PNSI at


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on May 2, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST 2001-10457

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  AEROVIAS de MEXICO, S.A. de C.V.
                             Date Filed:  April 15, 2003

Relief requested:  Exemption from 49 USC section 41301 to permit the
applicant to continue to conduct scheduled, combination services between
Cancun, Mexico, and Cincinnati, Ohio (only by code-share with Delta Air
Lines).

If renewal, date and citation of last action:  May 9, 2002, in this
Docket.

Applicant representative(s):  William C. Evans,<PHONE_NUMBER>       DOT
analyst:  Allen F. Brown,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.			       			                        Action date:  May
2, 2003

Effective dates of authority granted:  May 2, 2003, through May 9, 2004.

Basis for approval:  United States-Mexico Air Transport Services
Agreement

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated: Standard exemption
conditions.

Special conditions/Remarks:  Aeromexico may conduct this service only by
code-share with Delta Air Lines.  (We approved Delta’s code-share
request under Part 212 for this service on May 9, 2002, in this Docket.)

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
_______________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp


[Federal Register Volume 80, Number 119 (Monday, June 22, 2015)]
[Notices]
[Pages 35652-35653]
[FR Doc No: 2015-15162]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0097]

Mirwaiss Aminzada: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
permanently debarring Mirwaiss Aminzada from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Mr. Aminzada was
convicted of a felony under Federal law for conduct relating to the
regulation of a drug product. Mr. Aminzada was given notice of the
proposed permanent debarment and an opportunity to request a hearing
within the timeframe prescribed by regulation. Mr. Aminzada failed to
request a hearing. Mr. Aminzada's failure to request a hearing
constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is effective June 22, 2015.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade (ELEM-4144), Office of
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Drive,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual if FDA finds that the individual
has been convicted of a felony under Federal law for conduct relating
to the regulation of any drug product under the FD&C Act.
    On June 10, 2014, the U.S. District Court for the Eastern District
of Virginia entered judgment against Mr. Aminzada for one count of
introducing misbranded drugs into interstate commerce with intent to
defraud or mislead, in violation of sections 301(a) and 303(a)(2) of
the FD&C Act (21 U.S.C. 331(a) and 333(a)(2)).
    FDA's finding that debarment is appropriate is based on the felony
conviction referenced herein. The

factual basis for this conviction is as follows: Between around August
2009 and August 2013, Mr. Aminzada owned and operated several companies
dedicated to international sales, including Royal Canadian Imports
(headquartered in Canada), and Essa Gulf Trading (headquartered in
Dubai, United Arab Emirates).
    Between approximately August 2009 and August 2012, Mr. Aminzada
sold misbranded chemotherapy drugs and injectable cosmetic drugs to
Gallant Pharma International, Inc. (Gallant Pharma) for resale in the
United States. Neither of Mr. Aminzada's companies were licensed as a
prescription drug wholesaler anywhere in the United States. Mr.
Aminzada admitted that the drugs he sold to Gallant Pharma for resale
in the United States were prescription only, and that many of the drugs
were misbranded in that the drugs did not bear adequate directions for
use and were not subject to an exemption from that requirement, and
were accompanied by non-FDA approved packaging and inserts, which were
sometimes written in foreign languages. The drugs Mr. Aminzada sold to
Gallant Pharma also lacked the FDA-required pedigree, which protects
patients' health by tracking each sale, purchase, or trade of a drug
from the time of manufacturing to delivery to the patient. Between
August 2009 and August 2012, Mr. Aminzada received at least $586,798 in
wire transfers from Gallant Pharma, representing revenues from sales of
such drugs to Gallant Pharma. Mr. Aminzada admitted that his actions
were in all respect knowing, voluntary, intentional, and did not occur
by accident, mistake, or for another innocent reason.
    As a result of his conviction, on March 9, 2015, FDA sent Mr.
Aminzada a notice by certified mail proposing to permanently debar him
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
the finding, under section 306(a)(2)(B) of the FD&C Act, that Mr.
Aminzada was convicted of a felony under Federal law for conduct
related to the regulation of a drug product. FDA determined that Mr.
Aminzada's felony conviction was related to the regulation of drug
products because the conduct underlying his conviction undermined FDA's
regulatory oversight over drug products marketed in the United States
by intentionally introducing into interstate commerce drug products
that did not bear adequate directions for use and were not subject to
an exemption from that requirement, and which, among other things, were
accompanied by non-FDA approved packaging and inserts. The proposal
also offered Mr. Aminzada an opportunity to request a hearing,
providing him 30 days from the date of receipt of the letter in which
to file the request, and advised him that failure to request a hearing
constituted a waiver of the opportunity for a hearing and of any
contentions concerning this action. The proposal was received on March
16, 2015. Mr. Aminzada failed to respond within the timeframe
prescribed by regulation and has, therefore, waived his opportunity for
a hearing and has waived any contentions concerning his debarment (21
CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import
Operations, Office of Regulatory Affairs, under section 306(a)(2)(B) of
the FD&C Act, under authority delegated to the Director (Staff Manual
Guide 1410.35), finds that Mirwaiss Aminzada has been convicted of a
felony under Federal law for conduct relating to the regulation of a
drug product. Section 306(c)(2)(A)(ii) of the FD&C Act (21 U.S.C.
335a(c)(2)(A)(ii)) requires that Mr. Aminzada's debarment be permanent.
    As a result of the foregoing findings, Mirwaiss Aminzada is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application under
sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or
382), or under section 351 of the Public Health Service Act (42 U.S.C.
262), effective (see DATES) (see sections 201(dd), 306(c)(1)(B), and
306(c)(2)(A)(ii) of the FD&C Act, (21 U.S.C. 321(dd), 335a(c)(1)(B),
and 335a(c)(2)(A)(ii)). Any person with an approved or pending drug
product application who knowingly employs or retains as a consultant or
contractor, or otherwise uses the services of Mirwaiss Aminzada, in any
capacity during his debarment, will be subject to civil money penalties
(section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr.
Aminzada provides services in any capacity to a person with an approved
or pending drug product application during his period of debarment he
will be subject to civil money penalties (section 307(a)(7) of the FD&C
Act (21 U.S.C. 335b(a)(7))). In addition, FDA will not accept or review
any abbreviated new drug applications submitted by or with the
assistance of Mirwaiss Aminzada during his period of debarment (section
306(c)(1)(A) of the FD&C Act (21 U.S.C. 335a(c)(1)(A))).
    Any application by Mr. Aminzada for special termination of
debarment under section 306(d)(4) of the FD&C Act (21 U.S.C.
335a(d)(4)) should be identified with Docket No. FDA-2015-N-0097 and
sent to the Division of Dockets Management (see ADDRESSES). All such
submissions are to be filed in four copies. The public availability of
information in these submissions is governed by 21 CFR 10.20.
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 16, 2015.
Douglass Stearn,
Director, Division of Compliance Policy, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2015-15162 Filed 6-19-15; 8:45 am]
BILLING CODE 4164-01-P


ER &

AR Assay: Initial Assumptions °

ER and AR binding assays have a long history of use so that a retrospective determination of relevance and reliability can be conducted. °

Binding assays need only standardization of a protocol which can be accomplished as part of the QSAR validation program. °

Due to the numerous variations in cell type,

receptor and reporter constructs, EPA should define performance criteria and test chemicals for qualification of an assay by the test sponsor as acceptable for use in the EDSP. ER and AR Assay: The Reality °

Despite a large data base on ER and AR binding assays, there is not enough data on common chemicals across various protocols and in various laboratories to permit a retrospective validation. °

Data on the transcriptional activation assays is substantially more limited and falls far short of adequacy for validation. ER &AR Assays: Where we are now °

Complete validation of the ER rat uterine cytosol assay. °

Complete validation of the AR rat prostate cytosol assay. °

Investigate commercial sources of recombinate human ER and primate AR. °

Test additional chemicals with the AR reporter gene assay developed by E.

Gray in RTP. °

Wait for expert panel report before deciding on further work.


[Federal Register Volume 80, Number 233 (Friday, December 4, 2015)]
[Rules and Regulations]
[Pages 75788-75791]
[FR Doc No: 2015-30629]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-6546; Directorate Identifier 2015-NM-179-AD;
Amendment 39-18338; AD 2015-24-06]
RIN 2120-AA64

Airworthiness Directives; Gulfstream Aerospace Corporation
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Gulfstream Aerospace Corporation Model GVI airplanes. This AD requires
repetitive breakaway torque checks and torqueing of the brake inlet
self-sealing couplings. This AD also requires revising the airplane
flight manual to include procedures to follow in the event of certain
display indications. This AD was prompted by reports of the self-
sealing couplings on the brake inlet fitting that have been found
backed out of the fully seated position. We are issuing this AD to
detect and correct inadequate torque on the self-sealing coupling. This
condition could result in an unannounced total loss of braking
capability on one or multiple brakes, which could result in a runway
overrun or asymmetrical braking that can lead to a lateral runway
excursion.

DATES: This AD is effective December 4, 2015.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of December 4,
2015.
    We must receive comments on this AD by January 19, 2016.

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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Gulfstream
Aerospace Corporation, Technical Publications Dept., P.O. Box 2206,
Savannah, GA 31402-2206; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Internet http://www.gulfstream.com/product_support/technical_pubs/pubs/index.htm. You may view this
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2015-6546.

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-2015-
6546; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (phone:
800-647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Gideon Jose, Aerospace Engineer,
Systems and Equipment Branch, ACE-119A, FAA, Atlanta Aircraft
Certification Office (ACO), 1701 Columbia Avenue, College Park, GA
30337; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We have received reports of self-sealing couplings on the brake
inlet fitting that have been found backed out of the fully seated
position. Due to the function of these couplings, this issue allows for
the self-sealing mechanism to activate and cut off hydraulic pressure
to the brake caliper, resulting in reduced or no braking ability on the
affected wheel while the brake pressure indications remain normal on
the flight deck indicators. Multiple coupling failures may lead to loss
of braking capability on more than one wheel, creating the potential
for loss of aircraft braking effectiveness on one or multiple brakes.
Since the flight deck brake pressure indications would appear normal
under these conditions, the crew will have no indications other than
the loss of braking control on one or

multiple brakes. Unannounced total loss of braking capability on one or
multiple brakes, could result in a runway overrun or asymmetrical
braking that can lead to a lateral runway excursion.

Related Service Information Under 1 CFR Part 51

    Gulfstream has issued G650 Alert Customer Bulletin 4A, dated
November 13, 2015; and G650ER Alert Customer Bulletin 4A, dated
November 13, 2015. The service information describes procedures for a
breakaway torque check and torqueing the brake inlet self-sealing
couplings. 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 of this
AD.

FAA's Determination

    We are issuing 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.

AD Requirements

    This AD requires accomplishing the actions specified in the service
information described previously, except as discussed under
``Difference Between the AD and the Service Information.''

Difference Between the AD and the Service Information

    Although Gulfstream G650 Alert Customer Bulletin 4A, dated November
13, 2015; and G650ER Alert Customer Bulletin 4A, dated November 13,
2015; recommend that the breakaway torque check and torqueing the brake
inlet self-sealing couplings be repeated only one time, this AD
requires repetitive accomplishment of the checks and torqueing of the
brake inlet self-sealing coupling at intervals not to exceed 100 flight
cycles. We have determined repetitive actions are necessary to address
the identified unsafe condition. We have coordinated this difference
with Gulfstream.

Interim Action

    We consider this AD interim action. The manufacturer is currently
developing a modification that will address the unsafe condition
identified in this AD and would terminate the repetitive actions in
this AD. Once this modification is developed, approved, and available,
we might consider additional rulemaking.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because an
unannounced total loss of braking capability on one or multiple brakes
can cause a runway overrun or asymmetrical braking that can lead to a
lateral runway excursion. Therefore, we find that notice and
opportunity for prior public comment are impracticable and that good
cause exists for making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, we invite you to send any written data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include the docket number FAA-2015-6546 and
Directorate Identifier 2015-NM-179-AD at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this AD. We will
consider all comments received by the closing date and may amend this
AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Explanation of ``RC'' Steps in Service Information

    The FAA worked in conjunction with industry, under the
Airworthiness Directive Implementation Aviation Rulemaking Committee
(ARC), to enhance the AD system. One enhancement was a new process for
annotating which steps in the service information are required for
compliance with an AD. Differentiating these steps from other tasks in
the service information is expected to improve an owner's/operator's
understanding of crucial AD requirements and help provide consistent
judgment in AD compliance. The steps identified as Required for
Compliance (RC) in any service information identified previously have a
direct effect on detecting, preventing, resolving, or eliminating an
identified unsafe condition.
    For service information that contains steps that are labeled as RC,
the following provisions apply: (1) The steps labeled as RC, including
substeps under an RC step and any figures identified in an RC step,
must be done to comply with the AD, and an AMOC is required for any
deviations to RC steps, including substeps and identified figures; and
(2) steps not labeled as RC may be deviated from using accepted methods
in accordance with the operator's maintenance or inspection program
without obtaining approval of an AMOC, provided the RC steps, including
substeps and identified figures, can still be done as specified, and
the airplane can be put back in an airworthy condition.

Costs of Compliance

    We estimate that this AD affects 120 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                Action                        Labor cost            Cost per product      Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Breakaway torque check and torqueing   2 work-hours x $85 per   $170 per check/torque    $20,400 per check/
 of inlet self-sealing couplings.       hour = $170 per check/   cycle.                   torque cycle.
                                        torque cycle.
AFM revision.........................  1 work-hour x $85......  $85....................  $10,200.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our 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.
    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

    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 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.

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 airworthiness
directive (AD):

2015-24-06 Gulfstream Aerospace Corporation: Amendment 39-18338;
Docket No. FAA-2015-6546; Directorate Identifier 2015-NM-179-AD.

(a) Effective Date

    This AD is effective December 4, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Gulfstream Aerospace Corporation Model GVI
airplanes, certificated in any category, serial numbers 6001 and
6003 through 6163 inclusive.

    Note 1 to paragraph (c) of this AD:  Model GVI airplanes are
also referred to by marketing designations G650 and G650ER.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
gear.

(e) Unsafe Condition

    This AD was prompted by reports of the self-sealing couplings on
the brake inlet fitting that have been found backed out of the fully
seated position. We are issuing this AD to detect and correct
inadequate torque on the self-sealing coupling. This condition could
result in an unannounced total loss of braking capability on one or
multiple brakes, which could result in a runway overrun or
asymmetrical braking that can lead to a lateral runway excursion.

(f) Compliance

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

(g) Repetitive Breakaway Torque Checks and Torqueing

    (1) Within 15 days after the effective date of this AD, perform
a breakaway torque check and torque the brake inlet self-sealing
couplings, in accordance with Part I of the Accomplishment
Instructions of Gulfstream G650 Alert Customer Bulletin 4A, dated
November 13, 2015; or Gulfstream G650ER Alert Customer Bulletin 4A,
dated November 13, 2015; as applicable.
    (2) Within 100 flight cycles after completing the actions
required by paragraph (g)(1) of this AD, perform a breakaway torque
check and torque the brake inlet self-sealing couplings, in
accordance with Part II of the Accomplishment Instructions of
Gulfstream G650 Alert Customer Bulletin 4A, dated November 13, 2015;
or Gulfstream G650ER Alert Customer Bulletin 4A, dated November 13,
2015; as applicable. Repeat the actions thereafter at intervals not
to exceed 100 flight cycles.

(h) Revision to Airplane Flight Manual (AFM)--Dispatch Limitations

    Within 15 days after the effective date of this AD, revise the
Limitations section of the AFM to include the statement found in
figure 1 to paragraph (h) of this AD. This may be done by inserting
a copy of this AD into the AFM. When a statement identical to that
in figure 1 to paragraph (h) of this AD has been included in the
general revisions of the AFM, the general revisions may be inserted
into the AFM, and the copy of this AD may be removed from the AFM.
[GRAPHIC] [TIFF OMITTED] TR04DE15.000

(i) Revision to AFM--In-flight Warning

    Within 15 days after the effective date of this AD, revise the
Limitations section of the AFM to include the statement found in
figure 2 to paragraph (i) of this AD. This may be done by inserting
a copy of this AD into the AFM. When a statement identical to that
in figure 2 to paragraph (i) of this AD has been included in the
general revisions of the AFM, the general revisions may be inserted
into the AFM, and the copy of this AD may be removed from the AFM.
[GRAPHIC] [TIFF OMITTED] TR04DE15.001

(j) Credit for Previous Actions

    This paragraph provides credit for the actions required by
paragraph (g)(1) of this AD, if those actions were performed before
the effective date of this AD using Gulfstream G650 Alert Customer
Bulletin 4, dated November 6, 2015; or Gulfstream G650ER Alert
Customer Bulletin 4, dated November 6, 2015; which are not
incorporated by reference in this AD.

(k) No Reporting Requirement

    Although Gulfstream G650 Alert Customer Bulletin 4A, dated
November 13, 2015; and Gulfstream G650ER Alert Customer Bulletin 4A,
dated November 13, 2015; specify to submit certain information to
the manufacturer, this AD does not require that action.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta Aircraft Certification Office (ACO),
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 ACO, send it to the
attention of the person identified in paragraph (m) of this AD.
    (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.
    (3) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of paragraphs
(l)(3)(i) and (l)(3)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. An AMOC is required for any deviations to RC steps,
including substeps and identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(m) Related Information

    For more information about this AD, Gideon Jose, Aerospace
Engineer, Systems and Equipment Branch, ACE-119A, FAA, Atlanta
Aircraft Certification Office (ACO), 1701 Columbia Avenue, College
Park, GA 30337; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(n) 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) Gulfstream G650 Alert Customer Bulletin 4A, dated November
13, 2015.
    (ii) Gulfstream G650ER Alert Customer Bulletin 4A, dated
November 13, 2015.
    (3) For Gulfstream service information identified in this AD,
contact Gulfstream Aerospace Corporation, Technical Publications
Dept., P.O. Box 2206, Savannah, GA 31402-2206; telephone 800-810-
4853; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet http://www.gulfstream.com/product_support/technical_pubs/pubs/index.htm.
    (4) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Administration (NARA). For
information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on November 25, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-30629 Filed 12-3-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)]
[Proposed Rules]
[Pages 13086-13088]
[FR Doc No: 2017-04692]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2017-0028; FRL-9958-81-Region 9]

Approval of California Air Plan Revisions, Western Mojave Desert,
Rate of Progress Demonstration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a state implementation plan revision submitted by the State of
California to meet Clean Air Act requirements applicable to the Western
Mojave Desert (WMD) ozone nonattainment area. The EPA is proposing to
approve the initial six-year 15 percent rate of progress demonstration
to address requirements for the 1997 8-hour ozone national ambient air
quality standards (NAAQS).

DATES: Any comments must arrive by April 10, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2017-0028 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be removed or edited from Regulations.gov. For either
manner of submission, 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 whose disclosure 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, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Tom Kelly, EPA Region IX, by phone at
(415) 972-3856 or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to the EPA.

Table of Contents

I. Background
II. The State's SIP Submittal
    A. Documents Comprising the SIP Submittal
    B. CAA Procedural and Administrative Requirements for SIP
Submittals
III. The EPA's Evaluation and Action
    A. Requirements for the ROP Demonstration
    B. The ROP Demonstration in the 2014 SIP Update
    C. The EPA's Evaluation of the ROP Demonstration and Proposed
Action
IV. Statutory and Executive Order Reviews

I. Background

    Following promulgation of a new or revised NAAQS, the EPA is
required by the Clean Air Act (CAA or ``Act'') to designate areas
throughout the nation as attaining or not attaining the NAAQS. In the
``Final Rule To Implement the 8-Hour Ozone National Ambient Air

Quality Standard--Phase 1,'' (``Phase 1 Rule''), we designated
nonattainment areas for the 1997 8-hour ozone NAAQS. See 69 FR 23858
(April 30, 2004). The designations and classifications for the 1997 8-
hour ozone NAAQS for California areas are codified at 40 CFR 81.305. In
the Phase 1 Rule, the EPA classified the WMD as Moderate nonattainment
for the 1997 8-hour ozone NAAQS, with an attainment date no later than
June 15, 2010. See 69 FR 23858, 23884.
    On February 14, 2008, the California Air Resources Board (CARB)
requested that the EPA reclassify three California areas designated
nonattainment for the 1997 8-hour ozone NAAQS.\1\ For the WMD, CARB
requested reclassification from Moderate to Severe-17.\2\ On March 14,
2012, CARB submitted a clarification requesting that the EPA reclassify
the WMD from Moderate to Severe-15.\3\ Consistent with section
181(b)(3) of the CAA, we granted the State's request and reclassified
the WMD area from Moderate to Severe-15 nonattainment for the 1997 8-
hour ozone NAAQS, with an attainment date of no later than June 15,
2019. See 77 FR 26950 (May 8, 2012).
---------------------------------------------------------------------------

    \1\ See letter dated February 14, 2008, from James N. Goldstene,
Executive Officer, CARB, to Wayne Nastri, Regional Administrator,
EPA Region 9. In addition to the WMD, CARB requested that the EPA
reclassify the Ventura County and Sacramento Metro ozone
nonattainment areas under CAA section 181(b)(3) to higher
classifications for the 1997 8-hour ozone NAAQS. Pursuant to this
request, the EPA reclassified the Ventura County area from Moderate
to Serious nonattainment effective June 19, 2008, 73 FR 29073 (May
20, 2008), and reclassified the Sacramento Metro area from Serious
to Severe-15 nonattainment effective June 4, 2010, 75 FR 24409 (May
5, 2010).
    \2\ CARB subsequently submitted a SIP revision for this area to
address the attainment demonstration and related requirements for
severe-17 ozone nonattainment areas. See July 22, 2008, letter and
enclosures from James N. Goldstene, Executive Officer, CARB, to
Wayne Nastri, Regional Administrator, U.S. Environmental Protection
Agency, Region 9.
    \3\ See letter dated March 14, 2012, from James N. Goldstene,
Executive Director, CARB, to Jared Blumenfeld, Regional
Administrator, EPA Region 9.
---------------------------------------------------------------------------

    The WMD is located in northeast Los Angeles County and southwest
San Bernardino County. For a precise description of the geographic
boundaries of the area, see 40 CFR 81.305. The Los Angeles County
portion of the WMD area is under the jurisdiction of the Antelope
Valley Air Quality Management District (AVAQMD), and the San Bernardino
County portion of the area is under the jurisdiction of the Mojave
Desert Air Quality Management District (MDAQMD). The districts and
State are responsible for adopting and submitting plans to attain the
1997 8-hour ozone NAAQS for their areas. Designation of an area as
nonattainment starts the process for a state to develop and submit to
the EPA a state implementation plan (SIP) providing for attainment of
the NAAQS under title 1, part D of the CAA. For the 1997 8-hour ozone
NAAQS areas designated as nonattainment effective June 15, 2004, this
attainment SIP was due by June 15, 2007. See CAA section 172(b) and 40
CFR 51.908(a) and 51.910.

II. The State's SIP Submittal

A. Documents Comprising the SIP Submittal

    California has made several SIP submittals to address the CAA
planning requirements for attaining the 1997 8-hour ozone NAAQS in the
WMD. In today's proposal, we are proposing to take action only on the
15 percent volatile organic compound (VOC) rate of progress (ROP)
determination for the WMD. This demonstration is contained in the 2014
CARB staff report entitled ``Proposed Updates to the 1997 8-Hour Ozone
Standard, State Implementation Plans: Coachella Valley and Western
Mojave Desert 8-hour Ozone Nonattainment Areas'' (``2014 SIP
Update'').\4\
---------------------------------------------------------------------------

    \4\ CARB, Staff Report, ``Proposed Updates to the 1997 8-Hour
Ozone Standard, State Implementation Plans: Coachella Valley and
Western Mojave Desert 8-hour Ozone Nonattainment Areas,'' September
22, 2014. Other elements of CARB's SIP submittal include: AVAQMD,
``Federal 8-Hour Ozone Attainment Plan (Western Mojave Desert Non-
attainment Area),'' May 20, 2008; MDAQMD, ``Federal 8-Hour Ozone
Attainment Plan (Western Mojave Desert Non-attainment Area),'' June
9, 2008; CARB, ``2007 State Strategy for the California State
Implementation Plan,'' April 26, 2007, and Appendices A-G, Release
Date May 7, 2007. See letter from Richard Corey, Executive Officer
CARB, to Jared Blumenfeld, Regional Administrator, US. EPA dated
November 6, 2014, with enclosures.
---------------------------------------------------------------------------

B. CAA Procedural and Administrative Requirements for SIP Submittals

    Sections 110(a)(1) and (2) and 110(l) of the CAA require a state to
provide reasonable public notice and opportunity for public hearing
prior to the adoption and submittal of a SIP or SIP revision. To meet
this requirement, every SIP submittal should include evidence that
adequate public notice was given and an opportunity for a public
hearing was provided, consistent with the EPA's implementing
regulations in 40 CFR 51.102.
    For the 2014 SIP Update, CARB provided a public comment period from
September 22, 2014, to October 24, 2014, and held a public hearing, on
October 24, 2014. CARB formally adopted the 2014 SIP Update in Board
Resolution 14-29 on October 24, 2014. Therefore, we find the submittals
meet the procedural requirements of CAA sections 110(a) and 110(l).
    Section 110(k)(1)(B) of the CAA requires that the EPA determine
whether a SIP submittal is complete within 60 days of receipt. This
section also provides that any plan that the EPA has not affirmatively
determined to be complete or incomplete will become complete six months
after the date of submittal by operation of law. The EPA's SIP
completeness criteria are found at 40 CFR part 51, Appendix V. The 2014
SIP Update was submitted to the EPA on November 6, 2014, and became
complete by operation of law on May 6, 2015.

III. The EPA's Evaluation and Action

A. Requirements for the ROP Demonstration

    For areas classified as Moderate or above, CAA section 182(b)(1)
requires a SIP revision providing for ROP, defined as a one time, 15
percent actual VOC emission reduction during the six years following
the baseline year 1990, for an average reduction of 3 percent per year.
For areas designated Serious nonattainment or above, no further action
is necessary if the area fulfilled its ROP requirement for the 1-hour
NAAQS (from 1990-1996). As the EPA explained in the 1997 Ozone
Implementation Rule,\5\ for areas that did not meet the 15 percent VOC
ROP reduction for the 1-hour ozone NAAQS, a state may notify the EPA
that it wishes to rely on a previously submitted SIP (for the 1-hour
ozone NAAQS), or it may elect to submit a new or revised SIP addressing
the 15 percent VOC ROP reduction (for the 1997 8-hour ozone NAAQS). The
ROP demonstration requirement is a continuing applicable requirement
for the WMD under the EPA's anti-backsliding rules that apply once a
NAAQS has been revoked. See 40 CFR 51.1105(a)(1) and 51.1100(o)(4).
---------------------------------------------------------------------------

    \5\ 69 FR 23980 (October 27, 2004).
---------------------------------------------------------------------------

    The CAA outlines and EPA guidance details the method for
calculating the requirements for the 1990-1996 period. Section
182(b)(1) requires that reductions: (1) Be in addition to those needed
to offset any growth in emissions between the base year and the
milestone year; (2) exclude emission reductions from four prescribed
federal programs (i.e., the federal motor vehicle control program, the
federal Reid vapor pressure (RVP) requirements, any RACT corrections
previously specified by the EPA, and any inspection and maintenance (I/
M) program corrections necessary to meet the basic I/M level);

and (3) be calculated from an ``adjusted'' baseline relative to the
year for which the reduction is applicable.
    The adjusted base year inventory excludes emission reductions from
fleet turnover between 1990 and 1996 and from federal RVP regulations
that were promulgated by November 15, 1990, or required under section
211(h) of the Act. The effect of these adjustments is that states are
not able to take credit for emissions reductions that would result from
fleet turnover of current federal standard cars and trucks, or from
already existing federal fuel regulations. However, the SIP can take
full credit for the benefits of any new (i.e., post-1990) vehicle
emissions standards, as well as any other new federal or state motor
vehicle or fuel program that will be implemented in the nonattainment
area, such as Tier 1 exhaust standards, new evaporative emissions
standards, reformulated gasoline, enhanced I/M, California low
emissions vehicle program, and transportation control measures.
    The Southeast Desert, which includes the WMD, has attained the 1-
hour ozone NAAQS,\6\ but we have not approved a 15 percent ROP plan for
the 1-hour ozone NAAQS in the area. Per 40 CFR 51.1118, our
determination that the area attained the 1-hour ozone NAAQS means that
the Reasonable Further Progress (RFP) requirement (including the 15
percent ROP requirement for VOCs) no longer applies to the 1-hour ozone
NAAQS for the Southeast Desert area. The ROP demonstration requirement
remains in effect for the 1997 8-hour ozone NAAQS, and the WMD must
therefore demonstrate a six-year, 15 percent VOC ROP reduction.
---------------------------------------------------------------------------

    \6\ See 80 FR 20166 (April 15, 2015).
---------------------------------------------------------------------------

B. The ROP Demonstration in the 2014 SIP Update

    The 2014 SIP Update incorporates the 15 percent VOC ROP
demonstration as an element of the RFP demonstration, contained in
Appendix C and discussed on page 10. For today's notice, we are acting
only on the ROP emissions demonstration. Table C-2 in the 2014 SIP
Update was used to create Table 1 below. The revised 15 percent ROP
demonstration compares milestone year average summer weekday emissions
of VOC \7\ with a 2002 base year inventory. Based on the progress of
the VOC emissions reductions from 2002 to 2008, the State concluded
that the WMD did not meet the ROP demonstration requirement in 2008,
but found that it met the requirement in the subsequent reporting
milestone, in 2011. See 2014 SIP Update at 10.
---------------------------------------------------------------------------

    \7\ The 2014 SIP Update uses the term Reactive Organic Gasses,
or ROG, instead of VOC. These terms are essentially synonymous. For
simplicity, we use the term VOC in this notice to mean either VOC or
ROG.

 Table 1--15 Percent Rate of Progress Demonstration for VOC Emissions in
                               the WMD \a\
------------------------------------------------------------------------
                                                                  VOC
                        VOC emissions                          emissions
                                                                  (tpd)
------------------------------------------------------------------------
1. 2002 baseline inventory...................................       71.5
2. 2008 remaining emissions..................................       63.1
3. 2008 goal (remaining emissions after 15% ROP Reduction           58.2
 required from 2002 baseline)................................
4. ROP reduction achieved by 2008 (Compare Line 3 to Line 2)?         No
5. 2011 remaining emissions..................................       56.1
6. ROP reduction achieved by 2011 (compare Line 5 to Line 2)?        Yes
------------------------------------------------------------------------
\a\ Source: 2014 SIP Update, Table C-2.

C. The EPA's Evaluation of the ROP Demonstration and Proposed Action

    The 2014 SIP Update demonstrates that the WMD achieved the 15
percent reduction in VOC emissions required by CAA section 182(b)(1).
Although the state did not demonstrate these reductions within the six-
year period set out in this section, it has shown that all necessary
reductions were achieved in the earliest subsequent reporting period.
The EPA has previously approved ROP demonstrations with a demonstration
date more than six years from a baseline year.\8\ We therefore propose
to approve the ROP demonstration for the WMD.
---------------------------------------------------------------------------

    \8\ See, e.g., 65 FR 31485 (May 18, 2000). This approach was
upheld in Sierra Club v. EPA, 252 F.3d 943 (8th Cir. 2001).
---------------------------------------------------------------------------

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act 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 Clean Air Act.
Accordingly, this action merely proposes to approve State law as
meeting federal requirements and does not impose additional
requirements beyond those imposed by State law. For that reason, this
proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     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 Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, 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 the 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, Ozone, Volatile organic
compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: January 13, 2017.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2017-04692 Filed 3-8-17; 8:45 am]
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[Federal Register Volume 77, Number 123 (Tuesday, June 26, 2012)]
[Notices]
[Pages 38043-38044]
[FR Doc No: 2012-15521]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2458-198]

Great Lakes Hydro America, LLC; Notice of Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Application Type: Amendment of License Article 408.
    b. Project No.: 2458-198.
    c. Date Filed: April 13, 2012.
    d. Applicant: Great Lakes Hydro America, LLC.
    e. Name of Project: Penobscot Mills.
    f. Location: North Twin development, West Branch Penobscot River,
Maine.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Kevin Bernier, Manager, Licensing and
Compliance,

Great Lakes Hydro America, LLC, 1024 Central Street, Millinocket, ME
04462,<PHONE_NUMBER>, Ext. 118.
    i. FERC Contact: John K. Novak,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests, is July 23, 2012.
    All documents may be filed electronically via the Internet. See, 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site at http://www.ferc.gov/docs-filing/efiling.asp. If unable to be
filed electronically, documents may be paper-filed. To paper-file, an
original and seven copies should be mailed to: Secretary, Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426. Commenters can submit brief comments up to 6,000 characters,
without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and
contact information at the end of your comments.
    Please include the project number (P-2458-198) on any comments,
motions, or recommendations filed.
    k. Description of Request: Great Lakes Hydro America, LLC requests
Commission approval of amendment of Article 408 to eliminate the water
level management requirements in the North Twin impoundment for lake
trout spawning/incubation. The propagation of wild lake trout has not
been successful after several years of controlling the reservoir levels
in compliance with Article 408. Removal of reservoir level requirements
for lake trout would provide more flexibility in providing power and
non-power benefits at the development including the maintenance of
higher flows to benefit the tailwater fishery. Great Lakes Hydro
America, LLC proposes to request a modification to its Water Quality
Certificate from the Maine Department of Environment Protection.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov/docs-filing/efiling.asp. Enter the docket number excluding the last three digits in
the docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to project works which are the subject of the amendment. Agencies may
obtain copies of the application directly from the applicant. A copy of
any protest or motion to intervene must be served upon each
representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.

    Dated: June 20, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-15521 Filed 6-25-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 203 (Monday, October 23, 2017)]
[Notices]
[Pages 49033-49034]
[FR Doc No: 2017-22891]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidance for Methylphenidate Hydrochloride; New
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, the Agency, or we) is
announcing the availability of a new draft guidance for industry on
generic methylphenidate hydrochloride oral extended-release tablets
entitled ``Draft Guidance on Methylphenidate Hydrochloride.'' The new
draft guidance, when finalized, will provide product-specific
recommendations on, among other things, the design of bioequivalence
(BE) studies to support abbreviated new drug applications (ANDAs) for
methylphenidate hydrochloride oral extended-release tablets.

DATES: Submit either electronic or written comments on the draft
guidance by December 22, 2017 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-2007-D-0369 for ``Draft Guidance on Methylphenidate
Hydrochloride.'' 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. 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: Xiaoqiu Tang, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002,
301-796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific
guidances available to the public on FDA's Web site at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process to develop
and disseminate product-specific guidances and to provide a meaningful
opportunity for the public to consider and comment on the guidances.
This notice announces the availability of a new draft guidance for
generic methylphenidate hydrochloride oral extended-release tablets.
    FDA initially approved new drug application 018029 for RITALIN-SR
(methylphenidate hydrochloride oral extended-release tablets) in March
1982. We are now issuing a new draft guidance for industry on
methylphenidate hydrochloride oral extended-release tablets (``Draft
Guidance on Methylphenidate Hydrochloride'').
    In May 2016, KVK-Tech, Inc. (KVK-Tech) submitted a citizen petition
requesting, among other things, that FDA not accept for filing any new
ANDAs or approve any already received ANDAs for methylphenidate
hydrochloride oral extended-release tablets unless certain BE criteria
are met. FDA will consider any comments on the draft guidance on BE
recommendations for generic methylphenidate hydrochloride oral
extended-release tablets before responding to KVK-Tech's citizen
petition. (Docket No. FDA-2016-P-1247, available at https://www.regulations.gov).
    The new draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The new draft guidance,
when finalized, will represent the current thinking of FDA on the
design of BE studies to support ANDAs for methylphenidate hydrochloride
oral extended-release tablets. 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. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: October 17, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22891 Filed 10-20-17; 8:45 am]
 BILLING CODE 4164-01-P