[Federal Register Volume 84, Number 198 (Friday, October 11, 2019)]
[Rules and Regulations]
[Pages 54783-54785]
[FR Doc No: 2019-22307]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2019-0819]
RIN 1625-AA00

Safety Zone; Monte Foundation Fireworks Display, Soquel Cove,
Capitola, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters of Soquel Cove near the Capitola Wharf in support of
the Monte Foundation Fireworks Display on October 13, 2019. This safety
zone is necessary to protect personnel, vessels, and the marine
environment from the dangers associated with pyrotechnics. Unauthorized
persons or vessels are prohibited from entering into, transiting
through, or remaining in the safety zone without permission of the
Captain of the Port San Francisco or a designated representative.

DATES: This rule is effective from 7:30 p.m. to 8:50 p.m. on October
13, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0819 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Jennae Cotton, Waterways Management, U.S.
Coast Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port San Francisco
DHS Department of Homeland Security
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking with
respect to this rule because it is impracticable. The Coast Guard did
not receive final details for this event until September 23, 2019. It
is impracticable to go through the entire notice of proposed rulemaking
process because the Coast Guard must establish this temporary safety
zone by October 13, 2019 and lacks sufficient time to provide a
reasonable comment period and consider those comments before issuing
the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. For similar reasons as stated
above, notice and comment procedures would be impracticable in this
instance due to the short notice provided for this event.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port San
Francisco has determined that potential hazards associated with the
Monte Foundation Fireworks Display on October 13, 2019, will be a
safety concern for anyone within a 350-foot radius of the fireworks
display site starting 30 minutes before the fireworks display is
scheduled to commence and ending 30 minutes after the conclusion of the
fireworks display. For this reason, this temporary safety zone is
needed to protect personnel, vessels, and the marine environment in the
navigable waters around the fireworks firing site during the fireworks
display.

IV. Discussion of the Rule

    This rule establishes a safety zone around the fireworks firing
site for the Monte Foundation Fireworks Display. At 7:30 p.m. on
October 13, 2019, 30 minutes prior to the commencement of the 20-minute
fireworks display, the safety zone will encompass the navigable waters
of Soquel Cove, from surface to bottom, within a circle formed by
connecting all points 350 feet out from the fireworks firing site
located on the Capitola Wharf at approximate position 36[deg]58'10'' N,
121[deg]57'12'' W (NAD 83). The safety zone will terminate at 8:50 p.m.
on October 13, 2019.
    This regulation is needed to keep spectators and vessels away from
the immediate vicinity of the fireworks firing site to ensure the
safety of

participants, spectators, and transiting vessels. Except for persons or
vessels authorized by the COTP or the COTP's designated representative,
no person or vessel may enter or remain in the restricted areas. A
``designated representative'' means a Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty officer, or other officer
operating a Coast Guard vessel or a Federal, State, or local officer
designated by or assisting the COTP in the enforcement of the safety
zone.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size, limited
duration, and narrowly tailored geographic area of the safety zone.
This safety zone impacts a 350-foot-radius area of Soquel Cove in
Capitola, CA for a limited duration of one hour and 20 minutes. The
vessels desiring to transit through or around the temporary safety zone
may do so upon express permission from the COTP or the COTP's
designated representative.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section V.A. above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and U.S. Coast Guard Environmental Planning Policy,
COMDTINST 5090.1 (series), which guide the Coast Guard in complying
with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-
4370f), and have determined that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This rule involves a safety zone
lasting one hour and 20 minutes that prevents entry to a 350-foot-
radius area of Soquel Cove in Capitola, CA. It is categorically
excluded from further review under paragraph L60(a) in Table 3-1 of
Department of Homeland Security Directive 023-01. A Record of
Environmental Consideration supporting this determination is available
in the docket where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6,
and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T11-999 to read as follows:

Sec.  165.T11-999  Safety Zone; Monte Foundation Fireworks Display,
Soquel Cove, Capitola, CA.

    (a) Location. The following area is a safety zone: All navigable
waters of Soquel Cove, from surface to bottom, within a circle formed
by connecting all points 350 feet out from the fireworks firing site on
Capitola Wharf in approximate position 36[deg]58'10'' N,
121[deg]57'12'' W (NAD 83).
    (b) Definitions. As used in this section, ``designated
representative'' means a Coast Guard Patrol Commander, including a
Coast Guard coxswain, petty officer, or other officer operating a Coast
Guard vessel or a Federal, State, or local officer designated by or
assisting the Captain of the Port San Francisco (COTP) in the
enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart B of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or the COTP's designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or the COTP's designated representative to
obtain permission to do so. Vessel operators given permission to enter
or operate in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative. Persons and vessels may request permission to enter the
safety zone on VHF-23A or through the 24-hour Command Center at
telephone<PHONE_NUMBER>.
    (d) Enforcement period. This section will be enforced from 7:30
p.m. until 8:50 p.m. on October 13, 2019.
    (e) Information broadcasts. The COTP or the COTP's designated
representative will notify the maritime community of periods during
which this zone will be enforced in accordance with 33 CFR 165.7.

    Dated: October 7, 2019.
Marie B. Byrd,
Captain, U.S. Coast Guard, Captain of the Port, San Francisco.
[FR Doc. 2019-22307 Filed 10-10-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: April 21, 2009 (Volume 74, Number 75)]
[Rules and Regulations]
[Page 18118-18121]
[DOCID:fr21ap09-5]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0360; Directorate Identifier 2009-NM-039-AD;
Amendment 39-15887; AD 2009-09-01]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A318, A319, A320 and A321
Series Airplanes

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

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    During a routine inspection on an Airbus A321 aircraft, the
operator discovered that a bearing of the flap track No. 1 pendulum
assembly had migrated out of position. * * * This condition, if not
corrected, could lead to separation of the bearing/flap track
assembly, resulting in the detachment of the affected flap surface
from the wing and consequent loss of control of the aircraft.
* * * * *
This AD requires actions that are intended to address the unsafe
condition described in the MCAI.

DATES: This AD becomes effective May 6, 2009.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of May 6, 2009.
    We must receive comments on this AD by May 21, 2009.

ADDRESSES: You may send comments 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 W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Tim Dulin, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,

1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2141; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA) which is the Technical
Agent of the Member States of the European Community, has issued EASA
Airworthiness Directive 2009-0025, dated February 10, 2009 [Corrected
February 11, 2009] (referred to after this as ``the MCAI''), to correct
an unsafe condition for the specified products. The MCAI states:

    During a routine inspection on an Airbus A321 aircraft, the
operator discovered that a bearing of the flap track No. 1 pendulum
assembly had migrated out of position. The investigation has
confirmed that the pendulum bearing migration was probably due to
the methods used during in-service replacement of the bearing during
maintenance, whereby the necessary special tools, fixtures and
equipment were not used. This condition, if not corrected, could
lead to separation of the bearing/flap track assembly, resulting in
the detachment of the affected flap surface from the wing and
consequent loss of control of the aircraft.
    For the reasons described above, this AD requires a one-time
inspection of the affected flap track No.1 pendulum assembly for
bearing migration and, in case any bearing is found to have
migrated, the replacement of the affected flap track pendulum
assembly.

    Note: Based on this in-service experience, showing the potential
safety effect of not following the TC Holder's accomplishment
instructions, Airbus has removed the instructions to replace the
bearing in the pendulum assembly from the A320 Family aircraft
maintenance documentation. Component Maintenance Manual (CMM)
references are 27-54-43 for the A318, A319 and A320, and 27-54-42
for the A321.

If no migration is found during the one-time inspection for migration,
the required actions include an inspection for correct swaging of the
spherical bearing in the No.1 flap track pendulum assembly. If the
bearing is found incorrectly swaged, the corrective actions include
contacting Airbus for repair instructions and doing the repair. You may
obtain further information by examining the MCAI in the AD docket.

Relevant Service Information

    Airbus has issued Service Bulletin A320-57-1144, including Appendix
01, Revision 01, dated June 18, 2007; and Service Bulletin A320-
57A1146, including Appendix 01, dated September 21, 2007. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between the AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the AD.

FAA's 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 of
the possible separation of the bearing and flap track assembly,
resulting in the detachment of the affected flap surface from the wing
and consequent loss of control of the airplane. Therefore, we
determined that notice and opportunity for public comment before
issuing this AD are impracticable and that good cause exists for making
this amendment effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2009-0360; Directorate
Identifier 2009-NM-039-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.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2009-09-01 Airbus: Amendment 39-15887. Docket No. FAA-2009-0360;
Directorate Identifier 2009-NM-039-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective May 6,
2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Airbus Model A318-111, A318-112, A318-
121, A318-122, A319-111, A319-112, A319-113, A319-114, A319-115,
A319-131, A319-132, A319-133, A320-111, A320-211, A320-212, A320-
214, A320-231, A320-232, A320-233, A321-111, A321-112, A321-131,
A321-211, A321-212, A321-213, A321-231, and A321-232 airplanes;
certificated in any category; except airplanes identified in
paragraph (c)(1), (c)(2), (c)(3), or (c)(4) of this AD.
    (1) Any airplane for which the date of issuance of the original
French or German airworthiness certificate or the date of issuance
of the original French or German export certificate of
airworthiness, is after February 24, 2009 (the effective date of
European Aviation Safety Agency (EASA) Airworthiness Directive 2009-
0025 [Corrected: February 11, 2009]).
    (2) Any airplane for which it can be positively determined from
records review that the bearing of any pendulum assembly has not
been replaced or re-swaged since the date of issuance of the
original French or German airworthiness certificate or the date of
issuance of the original French or German export certificate of
airworthiness.
    (3) Any airplane inspected prior to the effective date of this
AD in accordance with Airbus Service Bulletin A320-57A1146, dated
September 21, 2007 (for Model A318, A319 and A320 series airplanes);
or in accordance with Airbus Service Bulletin A320-57A1144, dated
February 6, 2007, or A320-57-1144, Revision 01, dated June 18, 2007
(for Model A321 series airplanes), and on which it can be positively
determined from a records review that thereafter no replacement with
a pendulum assembly whose bearing has been replaced or re-swaged
since new manufacture was performed.
    (4) Any airplane inspected prior to the effective date of this
AD in accordance with Airbus Service Bulletin A320-57A1146, dated
September 21, 2007 (for Model A318, A319 and A320 series airplanes);
or in accordance with Airbus Service Bulletin A320-57A1144, dated
February 6, 2007, or A320-57-1144, Revision 01, dated June 18, 2007
(for Model A321 series airplanes), and on which it can be positively
determined from a records review that thereafter no pendulum bearing
replacement or re-swaging was performed.

Subject

    (d) Air Transport Association (ATA) of America Code 57: Wings.

Reason

    (e) The mandatory continued airworthiness information (MCAI)
states:

    During a routine inspection on an Airbus A321 aircraft, the
operator discovered that a bearing of the flap track No.1 pendulum
assembly had migrated out of position. The investigation has
confirmed that the pendulum bearing migration was probably due to
the methods used during in-service replacement of the bearing during
maintenance, whereby the necessary special tools, fixtures and
equipment were not used. This condition, if not corrected, could
lead to separation of the bearing/flap track assembly, resulting in
the detachment of the affected flap surface from the wing and
consequent loss of control of the aircraft.
    For the reasons described above, this AD requires a one-time
inspection of the affected flap track No.1 pendulum assembly for
bearing migration and, in case any bearing is found to have
migrated, the replacement of the affected flap track pendulum
assembly.

    Note: Based on this in-service experience, showing the potential
safety effect of not following the TC Holder's accomplishment
instructions, Airbus has removed the instructions to replace the
bearing in the pendulum assembly from the A320 Family aircraft
maintenance documentation. Component Maintenance Manual (CMM)
references are 27-54-43 for the A318, A319 and A320, and 27-54-42
for the A321.

If no migration is found during the one-time inspection for
migration, the required actions include an inspection for correct
swaging of the spherical bearing in the No.1 flap track pendulum
assembly. If the bearing is found incorrectly swaged, the corrective
actions include contacting Airbus for repair instructions and doing
the repair. You may obtain further information by examining the MCAI
in the AD docket.

Actions and Compliance

    (f) Unless already done, do the following actions:
    (1) Within 600 flight hours after the effective date of this AD,
inspect for migration, and correct swaging as applicable, of the
pendulum assembly of flap track number 1 in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A320-57A1146,
dated September 21, 2007 (for Model A318, A319 and A320 series
airplanes); or in accordance with the Accomplishment Instructions of
Airbus Service Bulletin A320-57-1144, Revision 01, dated June 18,
2007 (for Model A321 series airplanes).
    (i) If the bearing of the pendulum assembly of flap track number
1 is found to have migrated, before further flight, replace the
affected pendulum assembly with a new pendulum assembly, in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A320-57A1146, dated September 21, 2007 (for Model A318,
A319 and A320 series airplanes); or in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A320-57-1144,
Revision 01, dated June 18, 2007 (for Model A321 series airplanes).
    (ii) If the bearing of the pendulum assembly of flap track
number 1 is incorrectly swaged, before further flight, contact
Airbus for repair instructions and accomplish the repair.
    (2) After the effective date of this AD, no person shall replace
the bearing in the pendulum assembly of the flap track or install a
pendulum assembly, unless:
    (i) The pendulum assembly is of new manufacture, or
    (ii) It can be positively determined from a records review that
the bearing of the pendulum assembly has not been replaced or re-
swaged since new.
    (3) Accomplishment of the actions required by paragraph (f)(1),
(f)(2), and (f)(3) of this AD, before the effective date of this AD
in accordance with Airbus Service Bulletin A320-57A1144, dated
February 6, 2007, is acceptable for compliance with the
corresponding requirements of paragraph (f) of this AD for Airbus
Model A321 series airplanes.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN: Tim
Dulin, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington
98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC on any airplane to which the AMOC applies,
notify your principal maintenance inspector (PMI) or principal
avionics inspector (PAI), as appropriate, or lacking a principal
inspector, your local Flight Standards District Office.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act,

the Office of Management and Budget (OMB) has approved the
information collection requirements and has assigned OMB Control
Number 2120-0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2009-0025, dated February 10, 2009; Airbus Service
Bulletin A320-57-1144, Revision 01, dated June 18, 2007; and Airbus
Service Bulletin A320-57A1146, dated September 21, 2007, for related
information.

Material Incorporated by Reference

    (i) You must use Airbus Service Bulletin A320-57A1146, including
Appendix 01, dated September 21, 2007; or Airbus Service Bulletin
A320-57-1144, including Appendix 01, Revision 01, dated June 18,
2007; as applicable; to do the actions required by this AD, unless
the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Airbus, Airworthiness Office--EAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; e-mail<EMAIL_ADDRESS>Internet
http://www.airbus.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on April 8, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-8982 Filed 4-20-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)]
[Notices]
[Pages 28624-28629]
[FR Doc No: 2015-11982]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-D-1176 and FDA-2003-D-0202]

Compounding Animal Drugs From Bulk Drug Substances; Draft
Guidance for Industry; Availability; Withdrawal of Compliance Policy
Guide; Section 608.400 Compounding of Drugs for Use in Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry (GFI) #230 entitled
``Compounding Animal Drugs from Bulk Drug Substances.'' The draft
guidance describes FDA's policies with regard to compounding animal
drugs from bulk drug substances. When final, the guidance will reflect
FDA's current thinking on the issues addressed by the guidance.
    FDA is also announcing the withdrawal of the compliance policy
guide (CPG) entitled ``Section 608.400 Compounding of Drugs for Use in
Animals,'' which was issued in July 2003. This 2003 CPG is being
withdrawn because it is no longer consistent with FDA's current
thinking on the issues it addresses.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that FDA considers your comment on the draft
guidance before it begins work on the final version of the guidance,
submit either electronic or written comments on the draft guidance by
August 17, 2015. Submit written or electronic comments on the proposed
collection of information by August 17, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Policy and Regulations Staff (HFV-6), Center for
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one self-addressed adhesive label to assist
that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.
    Submit electronic comments on the draft guidance, including
comments regarding the proposed collection of information, to http://www.regulations.gov. Submit written comments on the draft guidance,
including comments regarding the proposed collection of information, to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: With regard to this draft guidance:
Division of Compliance, Center for Veterinary Medicine, Food and Drug
Administration (HFV-230), 7519 Standish Pl., Rockville, MD 20855, 240-
402-7001<EMAIL_ADDRESS>    With regard to the proposed collection of information: FDA PRA
Staff, Office of Operations, Food and Drug Administration, 8455
Colesville Rd.; COLE-14526, Silver Spring, MD 20993-0002;
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Draft Guidance

    FDA is announcing the availability of a draft GFI #230 entitled
``Compounding Animal Drugs from Bulk Drug Substances.'' The draft
guidance provides information to compounders of animal drugs and other
interested stakeholders on FDA's application of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) with respect to the compounding of
animal drugs from bulk drug substances.\1\
---------------------------------------------------------------------------

    \1\ FDA regulations define ``bulk drug substance'' as ``any
substance that is represented for use in a drug and that, when used
in the manufacturing, processing, or packaging of a drug, becomes an
active ingredient or a finished dosage form of the drug, but the
term does not include intermediates used in the synthesis of such
substances.'' 21 CFR 207.3(a)(4). ``Active ingredient'' is defined
as ``any component that is intended to furnish pharmacological
activity or other direct effect in the diagnosis, cure, mitigation,
treatment, or prevention of disease, or to affect the structure or
any function of the body of man or other animals. The term includes
those components that may undergo chemical change in the manufacture
of the drug product and be present in the drug product in a modified
form intended to furnish the specified activity or effect.'' 21 CFR
210.3(b)(7). Any component other than an active ingredient is an
``inactive ingredient.'' See 21 CFR 210.3(b)(8). Inactive
ingredients used in compounded drug products commonly include
flavorings, dyes, diluents, or other excipients.

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

    Sections 503A (21 U.S.C. 353a) and 503B (21 U.S.C. 353b) of the
FD&C Act do not apply to the compounding of animal drugs. The FD&C Act
does not distinguish between compounding animal drugs from bulk drug
substances and any other manufacturing or processing of animal drugs.
Except with respect to the limited exemption provided by the FD&C Act
described in this document, statutory provisions applicable to
manufactured animal drugs under the FD&C Act also apply to compounded
animal drugs.
    Section 512(a)(4) and (5) of the FD&C Act (21 U.S.C. 360b(a)(4) and
(5)), provide a limited exemption from certain requirements for use for
compounded animal drugs made from already approved animal or human
drugs. Such use is considered an extra-label use and the FD&C Act
provides that a compounded drug is exempt from the approval
requirements and requirements of section 502(f)(1) (21 U.S.C.
352(f)(1)) of the FD&C Act, if it meets the conditions set out in the
statute and the extra-label use regulations at 21 CFR part 530.
    This draft guidance does not address the compounding of animal
drugs from approved animal or human drugs pursuant to the extra-label
provisions of the law, nor does it address the repackaging of approved
animal drugs. FDA is considering whether guidance is needed on those
issues, and if so, will publish separate guidances. In section III, FDA
is asking for comment on specific questions about several issues
including the practice of compounding from approved animal and human
drugs and the repackaging of drugs for animal use to help determine
whether additional guidance is necessary on these topics.
    This draft guidance describes conditions under which FDA does not
generally intend to initiate enforcement action against State-licensed
pharmacies, licensed veterinarians, and facilities registered as
outsourcing facilities under section 503B of the FD&C Act (outsourcing
facilities) that compound animal drugs from bulk drug substances. The
draft guidance provides that FDA does not generally intend to take
action under sections 512(a), 501(a)(5) (21 U.S.C. 351(a)(5)),
501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)), and 502(f)(1) of the FD&C Act if
a State-licensed pharmacy or a licensed veterinarian compounds drugs
intended for use in animals from bulk drug substances in accordance
with all of the applicable conditions set out in the guidance. In
addition, the draft guidance provides that FDA does not generally
intend to take action under sections 512(a), 501(a)(5), and 502(f)(1)
of the FD&C Act if the drug product is compounded from a bulk drug
substance by an outsourcing facility and that meets all of the
applicable conditions set out in the guidance, and the drug product is
compounded from a bulk drug substance that appears on Appendix A of the
draft guidance.
    Importantly, the draft guidance provides that FDA generally intends
to enforce all other adulteration and misbranding provisions of the
FD&C Act against entities compounding animal drugs from bulk drug
substances.
    To ensure FDA can timely identify and address safety issues related
to animal drugs compounded from bulk drug substances, one of the
conditions, if met, under which FDA does not generally intend to take
action for violations of the provisions described previously is that
State-licensed pharmacies and veterinarians report any product defect
or serious adverse event associated with animal drugs they compound
from a bulk drug substance to FDA, within 15 days of becoming aware of
them, using Form FDA 1932a. FDA intends to use these adverse event
reports to identify animal drugs compounded from bulk drug substances
that present serious risks to animal health. Unlike for human drugs,
there are no State Departments of Health or Federal Agencies, such as
the Centers for Disease Control and Prevention (CDC), which are
responsible for identifying and tracing the source of injury and/or
disease in animals. Adverse event reporting regarding drugs compounded
from bulk drug substances by compounding pharmacies and veterinarians
will provide a mechanism for FDA to identify and possibly prevent
adverse events associated with compounded animal drugs. This is another
topic on which we are requesting specific comment in section III.
    Elsewhere in this issue of the Federal Register, FDA is publishing
a notice soliciting nominations for bulk drug substances that should be
included in Appendix A, ``List of Bulk Drug Substances That May Be Used
By an Outsourcing Facility to Compound Drugs for Use in Animals.'' The
notice also describes the information that should be provided to the
Agency in support of such nominations.

II. Withdrawal of 2003 Compliance Policy Guide

    In a notice published in the Federal Register of July 14, 2003 (68
FR 41591), FDA announced the availability of CPG Section 608.400 of the
Compliance Program Guidance Manual entitled, ``Compounding of Drugs for
Use in Animals.'' This document is being withdrawn because it is no
longer consistent with FDA's current thinking on the issue it
addresses. The current CPG does not focus on the three main concerns
FDA has about animal drug compounding: compounding copies of approved
animal or human drugs from bulk drug substances, compounding for food-
producing animals from bulk drug substances, and compounding office
stock from bulk drug substances. Because the CPG does not reflect FDA's
current thinking, to leave it in effect until this draft guidance is
finalized may confuse stakeholders about FDA's current enforcement
priorities. Stakeholders should be aware that, until this draft
guidance is finalized, FDA intends to look at the totality of the
circumstances when determining whether to take enforcement action for
unlawful animal drug compounding activities.

III. Specific Topics for Comment

    In addition to comments on the draft guidance as written, we are
specifically requesting comments on the following issues:
     Should the final guidance address the issue of FDA-
approved animal and human drugs that are in shortage or are otherwise
unavailable (e.g., disruptions in the manufacture or supply chain;
business decisions to stop marketing the drug; drug is subject to
Agency action based on safety, effectiveness, or manufacturing
concerns)? If so:
    [cir] How should these situations be addressed in the final
guidance?
    [cir] How should the final guidance define the terms ``shortage''
and ``unavailable''?
    [cir] What criteria should FDA use to determine if an approved
animal or human drug is in shortage or otherwise unavailable?
     Do United States Pharmacopeia and National Formulary (USP-
NF) \2\

chapters <795> and <797> provide suitable standards for animal drugs
compounded by veterinarians, and if not, what standards of safety,
purity, and quality should apply to animal drugs compounded by
veterinarians?
---------------------------------------------------------------------------

    \2\ Chapters <795> ``Pharmaceutical Compounding--Nonsterile
Preparations'' and <797> ``Pharmaceutical Compounding--Sterile
Preparations'' can be found in the combined United States
Pharmacopeia and National Formulary (USP-NF), available at http://www.usp.org/.
---------------------------------------------------------------------------

     Should licensed veterinarians be able to sell or transfer
an animal drug compounded from bulk drug substances by a State-licensed
pharmacy or an outsourcing facility to owners or caretakers of animals
under the veterinarian's care?
     How should FDA apply the condition to identify an
individual patient when it is not possible to identify an individual
animal (e.g., koi in a koi pond)?
     Should the final guidance include a condition on the
amount or percentage of compounded animal drugs that a pharmacy or
outsourcing facility can ship in interstate commerce? If so, what would
a reasonable amount be?
     Should facilities registered as outsourcing facilities
under section 503B of the FD&C Act be able to compound animal drugs
from bulk drug substances that do not appear on Appendix A for an
individually identified animal patient under conditions similar to
those applicable to state-licensed pharmacies (i.e., the conditions
contained in section III.A. of the draft guidance)?
     Is additional guidance needed to address the repackaging
of drugs for animal use?
    [cir] How widespread is the practice of repackaging drugs for
animal use?
    [cir] What types of drugs are repackaged for animal use, and why
are they repackaged?
    [cir] Have problems been identified with repackaged drugs for
animal use?
     Is additional guidance needed to address the compounding
of animal drugs from approved animal or human drugs under section
512(a)(4) or (a)(5) of the FD&C Act and part 530?
     Is additional guidance needed to address the compounding
of animal drugs from bulk drug substances for food-producing animals?
     As one condition under which FDA does not generally intend
to take action for certain violations of the FD&C Act if this and the
other conditions are followed, FDA is proposing that State-licensed
pharmacies and veterinarians report any product defect or serious
adverse event associated with animal drugs they compound from bulk drug
substances to FDA within 15 days of becoming aware of the product
defect or serious adverse event. Outsourcing facilities are required to
report adverse events associated with the drugs they compound. FDA
believes it is important to receive this information from State-
licensed pharmacies and veterinarians because there are no other State
Departments of Health or Federal Agencies (e.g., the CDC) charged with
identifying and tracing animal injuries or disease associated with an
animal drug compounded by these entities. FDA has the following
specific questions with respect to this proposed condition:
    [cir] How many State-licensed pharmacies and veterinarians compound
animal drugs from bulk drug substances and would potentially be
reporting product defects and serious adverse events to FDA?
    [cir] Are State-licensed pharmacies and veterinarians reporting the
same or similar information to any State regulatory agency (e.g., State
boards of pharmacy, State boards of veterinary medicine)? If so, how
many reports on average does each State-licensed pharmacy and
veterinarian submit to these State agencies each year?
    [cir] For purposes of the guidance, how should FDA define the terms
``product defect'' and ``serious adverse event''?
    [cir] Can FDA achieve the same objective of identifying and tracing
the source of injuries or disease associated with an animal drug
compounded from a bulk drug substance through means other than product
defect and serious adverse event reporting, and if so, what other
means? For example, would reports of product defects alone achieve the
same objective?

IV. Significance of Guidance

    This Level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on
compounding animal drugs from bulk drug substances. 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.

V. Paperwork Reduction Act of 1995

    This draft guidance contains proposed information collection
provisions that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44
U.S.C. 3501-3520). ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal Agencies to provide a
60-day notice in the Federal Register for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this
draft guidance, we invite comments on these topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
    Title: Compounding Animal Drugs from Bulk Drug Substances (OMB
Control Number 0910-NEW)
    Description of Respondents: The proposed collection of information
would affect State-licensed pharmacies, licensed veterinarians, and
outsourcing facilities that compound animal drugs from bulk drug
substances.
    Description: This draft guidance describes FDA's current thinking
regarding compounding animal drugs from bulk drug substances and
describes the conditions under which FDA does not generally intend to
take action for violations of the following sections of the FD&C Act:
512, 501(a)(5), 502(f)(1), and, where specified, 501(a)(2)(B), when a
State-licensed pharmacy, licensed veterinarian, or an outsourcing
facility compounds animal drugs from bulk drug substances. The draft
guidance provides three sets of conditions, one for each entity: State-
licensed pharmacies, licensed veterinarians, and outsourcing
facilities.
    This draft guidance only addresses the compounding of animal drugs
from bulk drug substances. It does not apply to the compounding of
animal drugs from approved new animal or new human drugs. Such
compounding can be conducted in accordance with the provisions of
section 512(a)(4) and (5) of the FD&C Act and part 530. In addition,
this guidance does not address the compounding of drugs intended for
use

in humans, which is addressed in other guidances.
    FDA estimates the burden of this collection of information as
follows:

Reporting

    This draft guidance contains no new reporting provisions. This
draft guidance refers to previously approved collections of information
found in FDA regulations. These collections of information are subject
to review by OMB under the PRA. The collections of information
regarding voluntary reporting of adverse drug experiences or product/
manufacturing defects on Form FDA 1932a, ``Veterinary Adverse Drug
Reaction, Lack of Effectiveness or Product Defect Report,'' have been
approved under OMB control number 0910-0284; the information collection
provisions regarding establishment registration under section 510 of
the FD&C Act (21 U.S.C. 360) have been approved under OMB control
number 0910-0777. This draft guidance also refers to proposed
collections of information regarding drugs made by an outsourcing
facility during the previous 6-month period as described in FDA's
notice of November 24, 2014 (79 FR 69857), announcing the availability
of a draft guidance entitled ``Electronic Reporting for Human Drug
Compounding Outsourcing Facilities.'' The proposed collections of
information in the draft guidance are subject to review by OMB under
the PRA. As required by the PRA, FDA published an analysis of the
information collection provisions of the draft guidance (79 FR 69857 at
69858) and intends to submit them for OMB approval.

Recordkeeping

    Entities compounding animal drugs from bulk drug substances should
keep adequate records to demonstrate that they are compounding such
drugs in accordance with all of the applicable conditions described in
the draft guidance. FDA tentatively concludes that it is usual and
customary for State-licensed pharmacies, veterinarians, and outsourcing
facilities to keep such records, and that this draft guidance imposes
no additional recordkeeping burden beyond those usual and customary for
the respondents to this collection, with the exception of that
described in section III.A.5. Nonetheless, table 1, row 1 provides a
nominal estimate of potential recordkeeping burden that respondents may
incur. FDA therefore specifically invites comment regarding whether
these provisions impose any effort beyond that which would normally be
incurred in absence of this draft guidance.
    A condition set forth in section III.A.5. is that, if there is an
FDA-approved animal or human drug with the same active ingredient(s),
the pharmacy determines that the compounded drug cannot be made from
the FDA-approved drug(s), and documents that determination.

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                            Number of       Number of records     Total annual
           Guidance section               recordkeepers     per recordkeeper        records         Average burden per recordkeeping      Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
III; general recordkeeping beyond                 138,551                1               138,551  0.01 (30 seconds)..................              1,386
 usual & customary.
III.A.5; documentation of                          75,000               84.67          6,350,000  0.01 (30 seconds)..................             63,500
 determination that compound drug
 cannot be made from the FDA-approved
 drug(s).
                                       ----------------------------------------------------------                                     ------------------
    Total.............................  .................  ..................  .................  ...................................             64,886
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    For row 1, we base our burden estimates on the American Veterinary
Medical Association's Market Research Statistics for 2013 for the total
number of veterinarians in practice minus those veterinarians in food
animal exclusive practice (63,500), the National Pharmacy Market
Summary SK&A of March 2010 for the total number of pharmacy sites
(75,000), and the number of registered outsourcing facilities as of
March 20, 2015 (51), for a total of 138,551 respondents.\3\
---------------------------------------------------------------------------

    \3\ The AVMA's Market Research Statistics--U.S. Veterinarians--
2013 can be found at this URL: (https://www.avma.org/KB/Resources/Statistics/Pages/Market-research-statistics-US-veterinarians.aspx);
the National Pharmacy Market Summary SK&A (March 2010) can be found
at this URL: http://www.skainfo.com/index.php; and the list of
registered outsourcing facilities can be found at this URL: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm.
---------------------------------------------------------------------------

    For row 2, we estimate that approximately 75,000 pharmacies will
receive approximately 6,350,000 prescriptions for compounded animal
drugs annually, and we also estimate that it will take approximately 30
seconds (0.01 hours) to document that the compounded drug cannot be
made from the FDA-approved drug(s) for a total of 63,500 hours
recordkeeping burden.
    A condition set forth in section III.A.2. of the draft guidance is
that State-licensed pharmacies can compound a drug in advance of
receipt of a prescription in a quantity that does not exceed the amount
of drug product that the State-licensed pharmacy compounded pursuant to
patient-specific prescriptions based on a history of receipt of such
patient-specific prescriptions for that drug product over any
consecutive 14-day period within the previous 6 months. The records
necessary for a State-licensed pharmacy to review to determine that its
compounding practices are within the condition set forth in section
III.A.2 of the draft guidance are records that State-licensed
pharmacies would already be keeping as part of usual and customary
business practice; therefore, no burden has been estimated for the
recordkeeping associated with this condition.
    This draft guidance also refers to proposed collections of
information currently undergoing the process of OMB review under the
PRA. Recordkeeping by outsourcing facilities, described in the draft
guidance for industry, ``Current Good Manufacturing Practice--Interim
Guidance for Human Drug Compounding Outsourcing Facilities Under
Section 503B of the FD&C Act'' announced July 2, 2014 (79 FR 37743),
will be reviewed by OMB in response to an information collection
request associated with that guidance.

Third-Party Disclosure

Prescriptions or Orders for Drugs Compounded From Bulk
    This draft guidance contains new third-party disclosures as
reported in table 2. Row 1 reflects a potential

burden associated with section III.C.9. regarding the following
condition: The veterinarian's prescription or order states, in addition
to the species, the condition(s) for which the substance is listed in
Appendix A. At this time, however, FDA has no data upon which to base
an estimated number of prescriptions or orders to outsourcing
facilities until the referenced list of bulk drugs (Draft Guidance;
Appendix A) is finalized. For purposes of this analysis, however, we
are providing an estimate of 1 as a placeholder.
    In section III.A.4., the draft guidance sets forth the following
condition: If the drug contains a bulk drug substance that is a
component of any marketed FDA-approved animal or human drug, there is a
change between the compounded drug and the comparable FDA-approved
animal or human drug made for an identified individual patient that
produces a clinical difference for that identified individual patient,
as determined by the veterinarian prescribing the compounded drug for
his/her patient under his/her care. If the drug contains a bulk drug
substance that is a component of a marketed FDA-approved animal or
human drug, the prescription or documentation accompanying the
prescription contains a statement that the change between the
compounded drug and the FDA-approved drug produces a clinical
difference for the individual identified patient. For example, the
veterinarian could state that, ``This compounded drug is needed to
treat [specifically identified patient] because the approved drug
product(s) cannot be divided or diluted into the small dose required.''

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of
               Activity                     Number of       disclosures per      Total annual       Average burden per disclosure         Total hours
                                           respondents         respondent        disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
III.C.9; documentation of condition to                  1                  1                  1  0.017 (1 minute)...................               0.017
 be treated.
Statements on prescription (Section                63,500                100          6,350,000  0.017 (1 minute)...................         107,950
 III.A.4 of the draft guidance).
                                       ---------------------------------------------------------                                     -------------------
    Total.............................  .................  .................  .................  ...................................         107,950
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    For row 2, we estimate that approximately 63,500 veterinarians
will, on average, each produce approximately 100 prescriptions for
compounded animal drugs annually for a total of 6,350,000
prescriptions. We also estimate that it will take approximately 1
minute (0.017 hours) to include the statement discussed in section
III.A.4 of the draft guidance on each prescription for a total of
107,950 hours third-party disclosure burden, as reported in table 1.
    It is usual and customary for licensed veterinarians to write
prescriptions in the normal course of their activities. The conditions
set forth in the guidance require veterinarians to include certain
information on prescriptions for animals drugs compounded from bulk
substances. It is usual and customary for veterinarians to include much
of this information (except as noted previously); therefore, the time
it would take to provide this information on prescriptions or documents
accompanying prescriptions is not included in the burden estimate
reported in table 2.
    Sections III.A.3 and III.A.6.b of the draft guidance set forth the
conditions that the following statements appear verbatim on or with
prescriptions for animal drugs compounded from bulk drug substances:
     ``This patient is not a food-producing animal.'' (Section
III.A.3).
     ``There are no FDA-approved animal or human drugs that can
be used as labeled or in an extra-label manner under section 512(a)(4)
and (5) and 21 CFR part 530 to appropriately treat the disease,
symptom, or condition for which this drug is being prescribed.''
(Section III.A.6.b).
    In addition, section III.C.3 of the draft guidance sets forth the
condition that the following statement appears verbatim on or with
prescriptions or orders for animal drugs compounded by outsourcing
facilities from bulk drug substances listed on Appendix A:
     ``This drug will not be dispensed for or administered to
food-producing animals.'' (Section III.C.3).
    We tentatively conclude that these statements are ``public
disclosures of information originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the
public'' (5 CFR 1320.3(c)(2)) and are therefore not subject to review
by OMB under the PRA. Thus, the time it would take to provide this
information is not included in the burden estimate reported in table 2.
Labeling of Drugs Compounded From Bulk Drug Substances
    The draft guidance sets forth conditions for the labeling of animal
drugs compounded from bulk drug substances. The draft guidance
indicates in sections III.A.11 and III.B.9 that, to meet the conditions
of the guidance, State-licensed pharmacies and licensed veterinarians
include on the label of any compounded drug: The species of the
intended animal patient, the name of the animal patient, and the name
of the owner or caretaker of the animal patient. It is usual and
customary for State-licensed pharmacies and licensed veterinarians to
include such information on the labels of compounded drugs in the
normal course of their activities; thus, the time it would take to
provide this information is not included in the burden estimate
reported in table 2.
    In addition, the draft guidance indicates in section III.C.10.
that, to meet the conditions of the guidance, outsourcing facilities
include on the label of any compounded animal drug pursuant to a
specific prescription or order: The active ingredient; the dosage form,
strength, and flavoring, if any; direction for use, as provided by the
veterinarian prescribing or ordering the drug; the quantity or volume,
whichever is appropriate; the lot or batch number of the drug; special
storage and handling instructions; the date the drug was compounded;
the beyond use date of the drug; the name of the veterinarian
prescribing or ordering the drug; the inactive ingredients; and the
address and phone number of the outsourcing facility that compounded
the drug. It is usual and customary for outsourcing facilities to
include such information on the labels of compounded drugs in the
normal course of their activities; thus, the time it would take to
provide this information is not included in the burden estimate
reported in table 2.

    The draft guidance indicates in section III.C.10 that, to meet the
conditions of the guidance, outsourcing facilities compounding animal
drug from bulk drug substances for office use in veterinary practices
include on the label of any compounded drug these four statements:
     ``Not for resale.''
     ``For use only in [fill in species and any associated
condition or limitation listed in Appendix A].''
     ``Compounded by [name of outsourcing facility].''
     ``Adverse events associated with this compounded drug
should be reported to FDA on a Form FDA 1932a.''
    We tentatively conclude that these four label statements are
``public disclosures of information originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the
public'' (5 CFR 1320.3(c)(2)) and are therefore not subject to review
by OMB under the PRA. Thus, the time it would take to provide this
information is not included in the burden estimate reported in table 2.
    This draft guidance also refers to previously approved collections
of information. A condition set forth in sections III.A.7., III.B.6,
and III.C.5 is that any bulk drug substance used is manufactured by an
establishment that is registered under section 510 of the FD&C Act
(including a foreign establishment that is registered under section
360(i) of the FD&C Act) and is accompanied by a valid certificate of
analysis. The information collection related to the disclosure of the
certificate of analysis is approved under OMB control number 0910-0139.
    Before the proposed information collection provisions contained in
this draft guidance become effective, we will publish a notice in the
Federal Register announcing OMB's decision to approve, modify, or
disapprove the proposed information collection provisions. An Agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.

VI. Comments

    Interested persons may submit either electronic comments regarding
this draft guidance to http://www.regulations.gov or written comments
to the Division of Dockets Management (see ADDRESSES). It is only
necessary to send one set of comments. Identify comments with Docket
No. FDA-2015-D-1176. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov.

VII. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm042450.htm or
http://www.regulations.gov.

    Dated: May 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11982 Filed 5-18-15; 8:45 am]
 BILLING CODE 4164-01-P