[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)]
[Notices]
[Page 18639]
[FR Doc No: 2017-07971]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-132-000]

National Fuel Gas Supply Corporation; Notice of Request Under
Blanket Authorization

    Take notice that on April 5, 2017 National Fuel Gas Supply
Corporation (National Fuel), located at 6363 Main Street,
Williamsville, New York 14221, filed in Docket No. CP17-132-000, a
prior notice request pursuant to sections 157.205, 157.208, and 157.213
of the Federal Energy Regulatory Commission's regulations under the
Natural Gas Act (NGA), seeking authorization to convert two existing
observation wells to injection/withdrawal wells in an area recently
added to the Beech Hill reservoir, located in the Beech Hill Storage
Field in Allegany County, New York. Additionally, National Fuel
proposes to construct and operate two new 4-inch coated steel well
lines, totaling approximately 6,000 feet, to connect the wells to the
field pipeline system, all as more fully set forth in the application,
which is on file with the Commission and open to public inspection. The
filing may also be viewed on the Web at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
David W. Reitz, Deputy General Counsel for National Fuel, 6363 Main
Street, Williamsville, New York 14221, at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>In the alternative, Alice A. Curtiss, Deputy
General Counsel for National Fuel may be contacted at<PHONE_NUMBER>;
or email at<EMAIL_ADDRESS>    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the NGA (18 CFR 157.205) file a protest to the request. If no protest
is filed within the time allowed therefore, the proposed activity shall
be deemed to be authorized effective the day after the time allowed for
protest. If a protest is filed and not withdrawn within 30 days after
the time allowed for filing a protest, the instant request shall be
treated as an application for authorization pursuant to section 7 of
the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenter's will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenter's will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and ill not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link. Persons unable to file
electronically should submit an original and 5 copies of the protest or
intervention to the Federal Energy regulatory Commission, 888 First
Street NE., Washington, DC 20426.

    Dated: April 13, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-07971 Filed 4-19-17; 8:45 am]
 BILLING CODE 6717-01-P


 " Johnston, A. Todd" < ajohnston@ nma. org>

07/ 14/ 2006 11: 47 AM To Jason Burnett/ DC/ USEPA/ US@ EPA cc Subject PM10 I attach a brief that explores the legal issues associated with retaining the current 1987 PM10 standard, and the historical application of that standard to mining sources. The bottom line is that retention of PM10 in any form is illegal. ( The paper also addresses the proposed alternative form that deducts PM2.5.) That aside, mining sources cannot comply. This, coupled with the understanding that coarse particles from rural/ mining sources do not cause harm at ambient exposures, has recognized by previous administrations, and Congress where it directed EPA to " use administrative good sense to exclude it" from regulation. The administrative measures that EPA and the states have traditionally used to discount these emissions from determinations of ambient compliance, have been a " band aid"   a way of avoiding the very real decision that is before the agency now  and will not survive if EPA makes a finding that coarse particles cause harm at ambient levels.

I have attached a chart clearly demonstrating the mining industries inability to comply with the PM10 standard. The data represented in the chart was compiled by EPA and used in its 1987/ 88 decision not to list surface coal mines as major PSD sources. There were two reasons for that determination: 1) the lack of health effects, and 2) the impossibility of compliance.


[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Pages 62493-62494]
[FR Doc No: 2016-21744]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. CP15-557-000]

Total Peaking Services, LLC; Notice of Schedule for Environmental
Review of the Vaporization Capacity Increase and Bog Compressor Project

    On September 23, 2015, Total Peaking Services, LLC (Total Peaking)
filed an application in Docket No. CP15-557-000 requesting a
Certificate of Public Convenience and Necessity pursuant to Section
7(c) of the Natural Gas Act to construct and operate certain liquefied
natural gas facilities. The proposed project is known as the
Vaporization Capacity Increase and BOG Compressor Project (Project),
and would increase the vaporization send out capacity at Total
Peaking's Milford, Connecticut facility from 90 million cubic feet per
day (MMcf/d) to 105 MMcf/d, along with the construction and operation
of an additional boil-off gas compressor unit.
    On October 7, 2015, the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Project.
Among other things, that notice alerted agencies issuing federal
authorizations of the requirement to complete all necessary reviews and
to reach a final decision on a request for a federal authorization
within 90 days of the date of issuance of the Commission staff's
Environmental Assessment (EA) for the Project. This instant notice
identifies the FERC staff's planned schedule for the completion of the
EA for the Project.

Schedule for Environmental Review

Issuance of EA October 14, 2016
90-day Federal Authorization Decision Deadline January 12, 2017

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    The Project would include modifications at Total Peaking's Milford,
Connecticut facility. Total Peaking would remove its existing
vaporizers and install a single vaporizer operating at 105 MMcf/d as
well as a heater system for the new vaporizer.

Total Peaking would also install a third boil-off gas compressor unit
powered by a 150 horsepower electric motor as well as ancillary
electrical upgrades.

Background

    On November 9, 2015, the Commission issued a Notice of Intent to
Prepare an Environmental Assessment for the Proposed Vaporization
Capacity Increase and BOG Compressor Project and Request for Comments
on Environmental Issues (NOI). The NOI was sent to affected landowners;
federal, state, and local government agencies; elected officials;
environmental and public interest groups; Native American tribes; other
interested parties; and local libraries and newspapers. The Commission
did not receive any comments in response to the NOI.
    The U.S. Department of Transportation is a cooperating agency in
the preparation of the EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to
www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC Web site (www.ferc.gov). Using the ``eLibrary'' link, select
``General Search'' from the eLibrary menu, enter the selected date
range and ``Docket Number'' excluding the last three digits (i.e.,
CP15-557), and follow the instructions. For assistance with access to
eLibrary, the helpline can be reached at<PHONE_NUMBER>, TTY (202) 502-
8659, or at<EMAIL_ADDRESS>The eLibrary link on the FERC
Web site also provides access to the texts of formal documents issued
by the Commission, such as orders, notices, and rule makings.

    Dated: September 2, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-21744 Filed 9-8-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: October 8, 2008 (Volume 73, Number 196)]
[Notices]
[Page 59009-59010]
[DOCID:fr08oc08-111]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58646; File No. SR-NASDAQ-2008-074]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by The NASDAQ Stock Market LLC To
Remove Rule 6800 From the Nasdaq Rules

September 25, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 17, 2008, The NASDAQ Stock Market LLC (``Nasdaq''), filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II, which Items have
been prepared by Nasdaq. Nasdaq has designated the proposed rule change
as constituting a non-controversial rule change under Rule 19b-4(f)(6)
under the Act,\3\ which renders the proposal effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to remove from the Nasdaq rule book Rule 6800
pertaining to Nasdaq's Mutual Fund Quotation Service (``MFQS''). The
Commission recently approved Nasdaq's proposal to remove MFQS-related
rules from the Nasdaq rule book, but reference to Rule 6800 was
inadvertently omitted from Nasdaq's proposal.\4\ Nasdaq proposes to
implement the proposed rule change immediately.
---------------------------------------------------------------------------

    \4\ Securities Exchange Act Release No. 34-58392 (August 20,
2008), 73 FR 50382 (August 26, 2008) (approving SR-NASDAQ-2008-019).
---------------------------------------------------------------------------

    Nasdaq proposes to delete in its entirety Rule 6800 (titled Mutual
Fund Quotation Service), showing this Rule in the rule book as
``Reserved.'' The text of the proposed rule change is available on
NASDAQ's Web site (http://nasdaqomx.cchwallstreet.com), at NASDAQ's
principal office, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, Nasdaq included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. Nasdaq has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Commission recently approved Nasdaq's proposal to remove MFQS-
related rules from the Nasdaq rule book.\5\ In its proposal, Nasdaq
stated its view that its rule book should not contain rules that do not
pertain to ``facilities'' of the exchange and that

MFQS is not a ``facility'' within the meaning of the Act. In approving
Nasdaq's proposal, the Commission found, based on representations made
by Nasdaq, that MFQS does not appear to be a facility of a national
securities exchange.
---------------------------------------------------------------------------

    \5\ Id.
---------------------------------------------------------------------------

    While Nasdaq's intent was to remove from its rule book all MFQS-
related rules, provisions of Rule 6800, which describe MFQS, were
inadvertently omitted from the list of provisions marked for deletion.
As a result, the fee-related provisions were removed, but the service
description in Rule 6800 remained. Given Nasdaq's view that its rule
book should not contain rules that do not pertain to ``facilities'' and
given that all MFQS fee provisions have already been removed, Nasdaq
proposes to delete Rule 6800. This proposal will have the effect of
conforming Nasdaq's rule book to Nasdaq's stated policy regarding
MFQS.\6\
2. Statutory Basis
    Nasdaq believes that MFQS is not a facility of a national
securities exchange within the meaning of the Act and the terms of MFQS
use are not rules that must be filed with the Commission under Section
19(b)(1) of the Act \7\ and Rule 19b-4 thereunder.\8\ Therefore,
removing the applicable provisions from the Nasdaq rule book would be
consistent with the provisions of Section 6(b) of the Act.\9\
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    \6\ As stated in the Commission's order approving removal of the
other MFQS provisions from the rule book, if Nasdaq were to propose
to modify the operation of MFQS such that it would fall within the
definition of a facility of an exchange in the Act (or to tie MFQS
pricing to an exchange activity), Nasdaq would file a proposed rule
change with the Commission. Id.
    \7\ 15 U.S.C. 78s(b)(1).
    \8\ 17 CFR 240.19b-4.
    \9\ 15 U.S.C. 78f(b).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \10\ and Rule 19b-
4(f)(6) thereunder.\11\ Nasdaq has requested that the Commission waive
the 30-day pre-operative period for ``non-controversial'' proposals
because removing Rule 6800 from the Nasdaq rule book is consistent with
the recently approved removal of other MFQS-related provisions from the
rule book. Waiving the 30-day pre-operative period contained in
Exchange Act Rule 19b-4(f)(6)(iii)\12\ will allow Nasdaq to implement
this change without unnecessary delay. In light of the foregoing, the
Commission believes that waiver of the 30-day operative delay is
consistent with the protection of investors and the public
interest.\13\ Accordingly, the Commission has determined to waive the
operative delay, and the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act,\14\ and Rule 19b-4(f)(6)
thereunder,\15\ with no operative delay.
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ Id.
    \13\ For purposes only of waiving the operative date of this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2008-074 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2008-074. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room on official
business days between the hours of 10 a.m. and 3 p.m. Copies of such
filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASDAQ-2008-074 and should be submitted on or before
October 29, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-23836 Filed 10-7-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 40 (Wednesday, February 28, 2018)]
[Rules and Regulations]
[Pages 8605-8606]
[FR Doc No: 2018-03930]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 83, No. 40 / Wednesday, February 28, 2018 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0111; Product Identifier 2016-SW-079-AD; Amendment
39-19211; AD 2018-05-02]
RIN 2120-AA64

Airworthiness Directives; AgustaWestland S.p.A. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
AgustaWestland S.p.A. (AgustaWestland) Model AW189 helicopters. This AD
requires replacing the seal and filler wedges of all emergency exit
windows. This AD was prompted by a report that some windows were
improperly glued when installed. The actions of this AD are intended to
correct an unsafe condition on these products.

DATES: This AD is effective April 4, 2018.

ADDRESSES: For service information identified in this final rule,
contact Leonardo S.p.A. Helicopters, Matteo Ragazzi, Head of
Airworthiness, Viale G.Agusta 520, 21017 C.Costa di Samarate (Va)
Italy; telephone +39-0331-711756; fax +39-0331-229046; or at http://www.leonardocompany.com/-/bulletins. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX
76177.

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-2017-
0111; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the European Aviation Safety Agency (EASA) AD, any
incorporated-by-reference service information, the economic evaluation,
any comments received, and other information. The street address for
Docket Operations (phone:<PHONE_NUMBER>) is U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Martin R. Crane, Aviation Safety
Engineer, Regulations & Policy Section, Rotorcraft Standards Branch,
FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-
5110; email [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    On November 2, 2017, at 82 FR 50847, the Federal Register published
our notice of proposed rulemaking (NPRM), which proposed to amend 14
CFR part 39 by adding an AD that would apply to AgustaWestland Model
AW189 helicopters. The NPRM proposed to require replacing the seal and
filler wedges of all emergency exit windows. The proposed requirements
were intended to prevent the failure of the windows from jettisoning
during an emergency.
    The NPRM was prompted by AD No. 2016-0216, dated October 28, 2016,
issued by EASA, which is the Technical Agent for the Member States of
the European Union, to correct an unsafe condition for Leonardo
Helicopters (previously Finmeccanica S.p.A., previously AgustaWestland)
Model AW189 helicopters, serial numbers 49007 through 49021, 49023,
49029, 49033, 49035, 89001, 89003, 89004, 92001, 92003, and 92005. The
EASA AD does not apply to windows that have been reinstalled at least
once since helicopter delivery and windows that are part of bubble
window kit part number (P/N) 8G5620F00111.
    EASA advises that some windows were installed with glue applied in
locations that were not in accordance with the approved design. This
condition, if not corrected, could prevent the jettisoning of
helicopter emergency exit windows, possibly affecting the evacuation of
crew and passengers during an emergency situation, EASA advises. EASA
consequently requires replacement of the seal and the filler wedges of
the emergency exit windows installed in the cockpit doors and cabin.
    The FAA is in the process of updating AgustaWestland's name change
to Leonardo Helicopters on its type certificate. Because this name
change is not yet effective, this AD specifies AgustaWestland.

Comments

    We gave the public the opportunity to participate in developing
this AD, but we received no comments on the NPRM.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Italy and are approved for operation in the United States. Pursuant to
our bilateral agreement with Italy, EASA, its technical representative,
has notified us of the unsafe condition described in the EASA AD. We
are issuing this AD because we evaluated all information provided by
EASA and determined the unsafe condition exists and is likely to exist
or develop on other helicopters of these same type designs and that air
safety and the public interest require adopting the AD requirements as
proposed.

Related Service Information

    We reviewed Leonardo Helicopters Bollettino Tecnico No. 189-118,
dated October 20, 2016. This service information specifies replacing
the seal and filler wedges on all cockpit door and cabin emergency exit
windows of Model AW189 helicopters, except on those windows that have
been replaced or that are part of bubble window kit P/N 8G5620F00111.

Costs of Compliance

    We estimate that this AD affects 2 helicopters of U.S. Registry and
that labor costs average $85 per work-hour. Based on these estimates,
we expect that removing and replacing the window seals and fillers
requires 40 work-hours and that parts cost about $834, for a total cost
of $4,234 per helicopter and $8,468 for the U.S. fleet.

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 helicopters 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 to the extent
that it justifies making a regulatory distinction; and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic 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

    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):

2018-05-02 AgustaWestland S.p.A.: Amendment 39-19211; Docket No.
FAA-2017-0111; Product Identifier 2016-SW-079-AD.

(a) Applicability

    This AD applies to Model AW189 helicopters, serial number 49007
through 49021, 49023, 49029, 49033, 49035, 89001, 89003, 89004,
92001, 92003, and 92005, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as improperly glued
emergency exit windows. This condition could result in the window
failing to jettison, preventing the occupants from exiting the
helicopter during an emergency.

(c) Effective Date

    This AD becomes effective April 4, 2018.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 75 hours time-in-service, replace the seal and filler
wedges of each cabin and cockpit door emergency exit window, except
bubble windows installed in accordance with bubble window kit part
number 8G5620F00111.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
Martin R. Crane, Aviation Safety Engineer, Regulations & Policy
Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy, Fort
Worth, TX 76177; telephone<PHONE_NUMBER>; email [email protected].
    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    (1) Leonardo Helicopters Bollettino Tecnico No. 189-118, dated
October 20, 2016, which is not incorporated by reference, contains
additional information about the subject of this AD. For service
information identified in this AD, contact Leonardo S.p.A.
Helicopters, Matteo Ragazzi, Head of Airworthiness, Viale G.Agusta
520, 21017 C.Costa di Samarate (Va) Italy; telephone +39-0331-
711756; fax +39-0331-229046; or at http://www.leonardocompany.com/-/bulletins. You may review a copy of the service information at the
FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency (EASA) AD No. 2016-0216, dated October 28, 2016. You
may view the EASA AD on the internet at http://www.regulations.gov
in AD Docket No. FAA-2017-0111.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 5600, Window/
Windshield System.

    Issued in Fort Worth, Texas, on February 21, 2018.
Scott A. Horn,
Deputy Director for Regulatory Operations, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2018-03930 Filed 2-27-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 103 (Friday, May 27, 2016)]
[Proposed Rules]
[Pages 33636-33637]
[FR Doc No: 2016-12485]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 97

[FRL-9947-02-OAR]

Availability of Data on Allocations of Cross-State Air Pollution
Rule Allowances From New Unit Set-Asides for the 2016 Compliance Year

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; notice of data availability (NODA).

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

SUMMARY: The Environmental Protection Agency (EPA) is providing notice
of the availability of preliminary calculations of emission allowance
allocations to certain units under the Cross-State Air Pollution Rule
(CSAPR). Under the CSAPR federal implementation plans (FIPs), portions
of each covered state's annual emissions budgets for each of the four
CSAPR emissions trading programs are reserved for allocation to
electricity generating units that commenced commercial operation on or
after January 1, 2010 (new units) and certain other units not otherwise
obtaining allowance allocations under the FIPs. The quantities of
allowances allocated to eligible units from each new unit set-aside
(NUSA) under the FIPs are calculated in an annual one- or two-round
allocation process. EPA has completed preliminary calculations for the
first round of NUSA allowance allocations for the 2016 compliance year
and has posted spreadsheets containing the calculations on EPA's Web
site. EPA will consider timely objections to the preliminary
calculations (including objections concerning the identification of
units eligible for allocations) and will promulgate a notice responding
to any such objections no later than August 1, 2016, the deadline for
recording the first-round allocations in sources' Allowance Management
System accounts. This notice may concern CSAPR-affected units in the
following states: Alabama, Arkansas, Florida, Georgia, Illinois,
Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan,
Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New York, North
Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee,
Texas, Virginia, West Virginia, and Wisconsin.

DATES: Objections to the information referenced in this notice must be
received on or before June 27, 2016.

ADDRESSES: Submit your objections via email to<EMAIL_ADDRESS>
Include ``2016 NUSA allocations'' in the email subject line and include
your name, title, affiliation, address, phone number, and email address
in the body of the email.

FOR FURTHER INFORMATION CONTACT: Questions concerning this action
should be addressed to Robert Miller at<PHONE_NUMBER> or
<EMAIL_ADDRESS>or Kenon Smith at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the CSAPR FIPs, the mechanisms by
which initial allocations of emission allowances are determined differ
for ``existing'' and ``new'' units. For ``existing'' units--that is,
units commencing commercial operation before January 1, 2010--the
specific amounts of CSAPR FIP allowance allocations for all compliance
years have been established through rulemaking. EPA has announced the
availability of spreadsheets showing the CSAPR FIP allowance
allocations to existing units in previous notices.\1\
---------------------------------------------------------------------------

    \1\ The latest spreadsheet of CSAPR FIP allowance allocations to
existing units, updated in 2014 to reflect changes to CSAPR's
implementation schedule but with allocation amounts unchanged since
June 2012, is available at http://www3.epa.gov/crossstaterule/actions.html. See Availability of Data on Allocations of Cross-State
Air Pollution Rule Allowances to Existing Electricity Generating
Units, 79 FR 71674 (December 3, 2014).
---------------------------------------------------------------------------

    ``New'' units--that is, units commencing commercial operation on or
after January 1, 2010--as well as certain older units that would not
otherwise obtain FIP allowance allocations do not have pre-established
allowance allocations. Instead, the CSAPR FIPs reserve a portion of
each state's total annual emissions budget for each CSAPR emissions
trading program as a new unit set-aside (NUSA) \2\ and establish an
annual process for allocating NUSA allowances to eligible units. States
with Indian country within their borders have separate Indian country
NUSAs. The annual process for allocating allowances from the NUSAs and
Indian country NUSAs to eligible units is set forth in the CSAPR
regulations at 40 CFR 97.411(b) and 97.412 (NOX Annual
Trading Program), 97.511(b) and 97.512 (NOX Ozone Season
Trading Program), 97.611(b) and 97.612 (SO2 Group 1 Trading
Program), and 97.711(b) and 97.712 (SO2 Group 2 Trading
Program). Each NUSA allowance allocation process involves up to two
rounds of allocations to new units followed by the allocation to
existing units of any allowances not allocated to new units. EPA
provides public notice at certain points in the process. This notice
concerns preliminary calculations for the first round of NUSA allowance
allocations for the 2016 compliance year.\3\
---------------------------------------------------------------------------

    \2\ The NUSA amounts range from two percent to eight percent of
the respective state budgets. The variation in percentages reflects
differences among states in the quantities of emission allowances
projected to be required by known new units at the time the budgets
were set or amended.
    \3\ At this time, EPA is not aware of any unit eligible for a
first-round allocation from any Indian country NUSA.
---------------------------------------------------------------------------

    The units eligible to receive first-round NUSA allocations are
defined in Sec. Sec.  97.412(a)(1), 97.512(a)(1), 97.612(a)(1), and
97.712(a)(1). Generally, eligible units include any CSAPR-affected unit
that has not been allocated allowances as an existing unit as well as
certain units that have been allocated allowances as existing units but
whose allocations have been deducted or not recorded because of
corrections or multi-year breaks in operations. EPA notes that a valid
allowance allocation may consist of zero allowances; thus, an existing
unit specifically allocated zero allowances in the spreadsheet of CSAPR
FIP allowance allocations to existing units is generally ineligible to
receive a NUSA allowance allocation.
    The quantity of allowances to be allocated through the 2016 NUSA
allowance allocation process for each state and emissions trading
program is generally the state's 2016 emissions budget less the sum of
(1) the total of the 2016 CSAPR FIP allowance allocations to existing
units and (2) the amount of the 2016 Indian country NUSA, if any.\4\

The amounts of NUSA allowances may be increased in certain
circumstances as set forth in Sec. Sec.  97.412(a)(2), 97.512(a)(2),
97.612(a)(2), and 97.712(a)(2).
---------------------------------------------------------------------------

    \4\ The quantities of allowances to be allocated through the
NUSA allowance allocation process may differ slightly from the NUSA
amounts set forth in Sec. Sec.  97.410(a), 97.510(a), 97.610(a), and
97.710(a) because of rounding in the spreadsheet of CSAPR FIP
allowance allocations to existing units.
---------------------------------------------------------------------------

    The amounts of first-round allocations to eligible units from each
NUSA are calculated according to the procedures set forth in Sec. Sec.
97.412(a)(3)-(7) and (12), 97.512(a)(3)-(7) and (12), 97.612(a)(3)-(7)
and (12), and 97.712(a)(3)-(7) and (12). Generally, the procedures call
for each eligible unit to receive a first-round 2016 NUSA allocation
equal to its 2015 emissions as reported under 40 CFR part 75 unless the
total of such allocations to all eligible units would exceed the amount
of allowances in the NUSA, in which case the allocations are reduced on
a pro-rata basis.\5\
---------------------------------------------------------------------------

    \5\ Subsequent allocations of any allowances remaining in any
2016 NUSA after first-round allocations will be addressed in future
notices. Any such allocations will be made according to the
procedures set forth in Sec. Sec.  97.412(a)(9), (10) and (12),
97.512(a)(9), (10) and (12), 97.612(a)(9), (10) and (12), and
97.712(a)(9), (10) and (12). Generally, new units that commenced
commercial operations in 2015 or 2016 will receive second-round 2016
NUSA allocations sufficient to bring the totals of their first- and
second-round allocations up to their 2016 emissions as reported
under 40 CFR part 75 unless the total of such second-round
allocations for all eligible units would exceed the remaining amount
of allowances in the NUSA, in which case the second-round
allocations will be reduced on a pro-rata basis. Any allowances
remaining in any NUSA after second-round allocations to new units--
along with any allowances remaining in any corresponding Indian
country NUSA--will be allocated to the state's existing units in
proportion to their respective 2016 CSAPR FIP allocations of non-
NUSA allowances.
---------------------------------------------------------------------------

    EPA notes that an allocation or lack of allocation of allowances to
a given EGU does not constitute a determination that CSAPR does or does
not apply to the EGU. EPA also notes that allocations are subject to
potential correction.
    The detailed unit-by-unit data and preliminary allowance allocation
calculations are set forth in Excel spreadsheets titled
``CSAPR_NUSA_2016_NOX_Annual_1st_Round_Prelim_Data'',
``CSAPR_NUSA_2016_NOX_OS_1st_Round_Prelim_Data'', and
``CSAPR_NUSA_2016_SO2_1st_Round_Prelim_Data,'' available on
EPA's Web site at http://www3.epa.gov/crossstaterule/actions.html. The
three spreadsheets show EPA's initial determinations of 2016 NUSA
allocations for new units subject to the CSAPR NOX Annual,
NOX Ozone Season, and SO2 (Group 1 and Group 2)
trading programs, respectively. Each of the spreadsheets contains a
separate worksheet for each state covered by that program showing, for
each unit identified as eligible for a first-round NUSA allocation, (1)
the unit's emissions in the 2015 control period (annual or ozone season
as applicable), (2) the maximum first-round 2016 NUSA allowance
allocation for which the unit is eligible (typically the unit's
emissions in the 2015 control period), (3) various adjustments to the
unit's maximum allocation, many of which are necessary only if the NUSA
pool is oversubscribed, and (4) the preliminary calculation of the
unit's first-round 2016 NUSA allowance allocation.
    Each state worksheet also contains a summary showing (1) the
quantity of allowances initially available in that state's 2016 NUSA,
(2) the sum of the first-round 2016 NUSA allowance allocations that
will be made to new units in that state, assuming there are no
corrections to the data, and (3) the quantity of allowances that would
remain in the 2016 NUSA for use in second-round allocations to new
units (or ultimately for allocation to existing units), again assuming
there are no corrections to the data.
    Objections should be strictly limited to the data and calculations
upon which the NUSA allowance allocations are based and should be
emailed to the address identified in ADDRESSES. Objections must
include: (1) Precise identification of the specific data and or
calculations the commenter believes are inaccurate, (2) new proposed
data and or calculations upon which the commenter believes EPA should
rely instead to determine allowance allocations, and (3) the reasons
why EPA should rely on the commenter's proposed data and or
calculations and not the data referenced in this notice.

    Authority:  40 CFR 97.411(b), 97.511(b), 97.611(b), and
97.711(b).

    Dated: May 19, 2016.
Reid P. Harvey,
Director, Clean Air Markets Division, Office of Atmospheric Programs,
Office of Air and Radiation.
[FR Doc. 2016-12485 Filed 5-26-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 208 (Tuesday, October 27, 2020)]
[Notices]
[Pages 68074-68082]
[FR Doc No: 2020-23687]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0030]

Memorandum of Understanding Addressing Certain Distributions of
Compounded Human Drug Products Between the State Board of Pharmacy or
Other Appropriate State Agency and the Food and Drug Administration;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a final standard memorandum of
understanding (MOU) entitled ``Memorandum of Understanding Addressing
Certain Distributions of Compounded Human Drug Products Between the
[insert State Board of Pharmacy or Other Appropriate State Agency] and
the U.S. Food and Drug Administration'' (final standard MOU). The final
standard MOU describes the responsibilities of a State Board of
Pharmacy or other appropriate State agency that chooses to sign the MOU
in investigating and responding to complaints related to drug products
compounded in such State and distributed outside such State and in
addressing the interstate distribution of inordinate amounts of
compounded human drug products.

DATES: The announcement of the MOU is published in the Federal Register
on October 27, 2020. FDA is withdrawing its revised draft standard MOU
that published on September 10, 2018 (83 FR 45631), as of October 27,
2020.

ADDRESSES: Submit electronic comments on the final standard MOU to
Docket No. FDA-2015-N-0030. Submit written comments on the final
standard MOU to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm.

1061, Rockville, MD 20852. All comments should be identified with the
docket number found in brackets in the heading of this document. Submit
written requests for single copies of the final standard MOU 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 document.

FOR FURTHER INFORMATION CONTACT: Alexandria Fujisaki, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5169, Silver Spring, MD 20993-0002, 240-
402-4078.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 353a) describes the conditions that must be satisfied for
drug products compounded by a licensed pharmacist or licensed physician
to be exempt from the following sections of the FD&C Act: (1) Section
501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good
manufacturing practice (CGMP) requirements), (2) section 502(f)(1) (21
U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate
directions for use), and (3) section 505 (21 U.S.C. 355) (concerning
the approval of drugs under new drug applications or abbreviated new
drug applications).
    One of the conditions to qualify for the exemptions listed in
section 503A of the FD&C Act is that (1) the drug product is compounded
in a State that has entered into an MOU with FDA that addresses the
distribution of inordinate amounts of compounded drug products
interstate and provides for appropriate investigation by a State agency
of complaints relating to drug products distributed outside such State;
or (2) if the drug product is compounded in a State that has not
entered into such an MOU, the licensed pharmacist, pharmacy, or
physician does not distribute, or cause to be distributed, compounded
drug products out of the State in which they are compounded in
quantities that exceed 5 percent of the total prescription orders
dispensed or distributed by such pharmacy or physician (5 percent
limit) (see section 503A(b)(3)(B)(i) and (ii) of the FD&C Act). Another
condition to qualify for the exemptions listed in section 503A of the
FD&C Act is that the drug is compounded for an identified individual
patient based on the receipt of a valid prescription order or a
notation, approved by the prescribing practitioner, on the prescription
order that a compounded product is necessary for the identified patient
(section 503A(a) of the FD&C Act). This MOU does not alter this
condition.
    Section 503A(b)(3)(B) of the FD&C Act directs FDA to develop, in
consultation with the National Association of Boards of Pharmacy
(NABP), a standard MOU for use by the States in complying with section
503A(b)(3)(B)(i).
    FDA is withdrawing the revised draft standard MOU entitled
``Memorandum of Understanding Addressing Certain Distributions of
Compounded Drug Products Between the State of [insert State] and the
U.S. Food and Drug Administration,'' which was issued in September 2018
(2018 revised draft standard MOU). The 2018 revised draft standard MOU
is superseded by the final standard MOU.

II. Previous Efforts To Develop a Standard MOU

    In the Federal Register of January 21, 1999 (64 FR 3301), FDA
announced the availability for public comment of a draft standard MOU,
developed in consultation with NABP (1999 draft standard MOU). Over
6,000 commenters submitted comments on the 1999 draft standard MOU.
Because of litigation over the constitutionality of the advertising,
promotion, and solicitation provision in section 503A of the FD&C
Act,\1\ the draft standard MOU was not completed. In 2013, section 503A
of the FD&C Act was amended by the Drug Quality and Security Act (DQSA)
(Pub. L. 113-54) to remove the advertising, promotion, and solicitation
provisions that were held unconstitutional, and FDA took steps to
implement section 503A, including to continue to develop the standard
MOU. In the Federal Register of February 19, 2015 (80 FR 8874), FDA
withdrew the 1999 draft standard MOU and issued the 2015 draft standard
MOU for public comment. FDA received more than 3,000 comments on the
2015 draft standard MOU. In the Federal Register of September 10, 2018
(83 FR 45631), FDA withdrew the 2015 draft standard MOU and issued the
2018 revised draft standard MOU for public comment. FDA received 38
comments during the comment period on the 2018 revised draft standard
MOU. By this notice, FDA is withdrawing the 2018 revised draft standard
MOU and issuing a final standard MOU, which the Agency developed in
consultation with NABP for use by the States in complying with section
503A(b)(3)(B).
---------------------------------------------------------------------------

    \1\ The conditions of section 503A of the FD&C Act originally
included restrictions on the advertising or promotion of the
compounding of any particular drug, class of drug, or type of drug
and the solicitation of prescriptions for compounded drugs. These
provisions were challenged in court and held unconstitutional by the
U.S. Supreme Court in 2002. See Thompson v. Western States Med.
Ctr., 535 U.S. 357 (2002).
---------------------------------------------------------------------------

III. Final Standard MOU

    In consultation with NABP, FDA has developed a final standard MOU.
FDA considered the comments submitted on the 2015 draft standard MOU
and 2018 revised draft standard MOU, as well as comments on the MOU
provisions it received in connection with a draft guidance on section
503A of the FD&C Act entitled ``Pharmacy Compounding of Human Drug
Products Under Section 503A of the Federal Food, Drug, and Cosmetic
Act'' (2013 draft 503A guidance) (see 78 FR 72901, December 4, 2013).
Below, FDA has summarized and discussed key provisions of the final
standard MOU and, where appropriate, summarized changes that the Agency
made in the final standard MOU. Drug products intended for veterinary
use, repackaged drug products, biological products subject to licensure
through a biologics license application under section 351 of the Public
Health Service Act (42 U.S.C. 262), and drug products compounded by
outsourcing facilities under section 503B of the FD&C Act are not the
subject of the final standard MOU.

A. Investigation of Complaints Relating to Compounded Human Drug
Products Distributed Outside the State

    The final standard MOU provides that a State Board of Pharmacy or
other appropriate State agency that enters into the MOU agrees to:
     Investigate complaints of adverse drug experiences and
product quality issues relating to human drug products compounded at a
pharmacy in the State and distributed outside the State. Investigations
performed by the State Board of Pharmacy or other appropriate State
agency under this MOU will include taking steps to assess whether there
is a public health risk associated with the compounded drug product and
whether such risk is adequately contained. Investigations will be
performed pursuant to the State Board of Pharmacy's or other
appropriate State agency's established investigatory policies and
procedures, including those related to prioritizing complaints,
provided they are not in conflict with the terms of the MOU;

     If the complaint is substantiated, take action that the
State Board of Pharmacy or other appropriate State agency considers to
be appropriate and warranted, in accordance with and as permitted by
State law, to ensure that the relevant pharmacy investigates the root
cause of the problem that is the subject of the complaint and
undertakes sufficient corrective action to address any identified
public health risk relating to the problem, including the risk that
future similar problems may occur;
     Maintain records of the complaints it receives regarding
adverse drug experiences or product quality issues relating to human
drug products compounded at a pharmacy, the investigation of each
complaint, and any response to or action taken as a result of a
complaint, beginning when the State Board of Pharmacy or other
appropriate State agency receives notice of the complaint. The State
Board of Pharmacy or other appropriate State agency will maintain these
records for at least 3 years. The 3-year period begins on the date of
final action on a complaint, or the date of a decision that the
complaint requires no action.
     Notify FDA by submission to an Information Sharing Network
or by email to<EMAIL_ADDRESS>as soon as possible, but no later
than 5 business days, after receiving a complaint involving a serious
adverse drug experience or serious product quality issue relating to a
human drug product compounded at a pharmacy and distributed outside the
State, and provide FDA with certain information about the complaint,
including the following: name and contact information of the
complainant, if available; name and address of the pharmacy that is the
subject of the complaint; and a description of the complaint, including
a description of any compounded human drug product that is the subject
of the complaint;
     Share with FDA, as permitted by State law, the results of
the investigation of a complaint after the State Board of Pharmacy or
other appropriate State agency concludes its investigation of a
complaint assessed to involve a serious adverse drug experience or
serious product quality issue. This information includes the following:
The State Board of Pharmacy's or other appropriate State agency's
assessment of whether the complaint was substantiated, if available;
and a description and the date of any actions the State Board of
Pharmacy or other appropriate State agency has taken to address the
complaint;
     Notify the appropriate regulator of physicians within the
State of complaints of which the State Board of Pharmacy or other
appropriate State agency receives that involve an adverse drug
experience or product quality issue relating to human drug products
compounded by a physician and distributed outside the State. The State
Board of Pharmacy or other appropriate State agency will also notify
FDA by submission to an Information Sharing Network or by email to
<EMAIL_ADDRESS>as soon as possible, but no later than 5 business
days, after receiving the complaint of the following information, if
available: Name and contact information of the complainant; name and
address of the physician that is the subject of the complaint; and
description of the complaint, including a description of any compounded
human drug product that is the subject of the complaint.
    The types of complaints of compounded drug products that should be
investigated include any adverse drug experience and product quality
issues. Even non-serious adverse drug experiences and product quality
issues can be indicative of problems at a compounding facility that
could result in product quality defects leading to serious adverse drug
experiences if not corrected. For example, inflammation around the site
of an injection can indicate drug product contamination from inadequate
sterile practices at the compounding pharmacy. If the pharmacy or
physician has inadequate sterile practices, other more serious
contamination could result in serious adverse drug experiences.
    The final standard MOU does not include specific directions to the
State Boards of Pharmacy or other appropriate State agencies relating
to how to conduct their investigation of complaints. Rather, as
recommended by comments submitted to FDA previously, the details of
such investigations are left to the State Board of Pharmacy's or other
appropriate State agency's discretion. For example, a State Board of
Pharmacy or other appropriate State agency may review an incoming
complaint describing an adverse drug experience and determine that such
a complaint does not warrant further investigation. In other cases, a
State Board of Pharmacy or other appropriate State agency may determine
that an incoming complaint contains insufficient information and
investigate further to determine appropriate action.
    The State Board of Pharmacy or other appropriate State agency
signing the final standard MOU would agree to notify FDA about certain
complaints and provide FDA with certain information about the
complaints so FDA could investigate the complaints itself, or take
other appropriate action. The 2018 revised draft standard MOU provided
that notification would occur as soon as possible, but no later than 3
business days of receipt of the complaint. The final standard MOU
provides that notification will occur as soon as possible, but no later
than 5 business days after the State Board of Pharmacy or other
appropriate State agency receives the complaint. This period will
continue to facilitate early Federal/State collaboration on serious
adverse drug experiences and serious product quality issues that have
the potential to affect patients in multiple States, while providing
for notification in a timeframe that is more feasible for the State
Boards of Pharmacy or other appropriate State agencies. FDA increased
the time for notifying FDA in the final standard MOU in response to
comments expressing concern about having sufficient time to process
complaints and notify FDA. We note that FDA has staff on call 24 hours
a day to receive information in emergency situations.
    Comments on the 2015 draft MOU expressed concern with certain
provisions regarding States entering into the MOU and agreeing to take
action not permitted by State law or implying that, after taking
action, the State made a legal determination that a complaint had been
resolved. The revised draft standard MOU clarified that the State
should investigate and take action that the State considers to be
appropriate with respect to the complaint in accordance with and as
permitted by State law. FDA also clarified that, by signing the MOU,
the State agrees to take steps to assess whether there is a public
health risk associated with the compounded drug product and whether
such risk is adequately contained rather than make definitive
determinations of risk or confirm containment. The final standard MOU
retains these revisions that addressed the concerns from comments on
the 2015 draft.

B. Distribution of Inordinate Amounts of Compounded Human Drug Products
Interstate

    For purposes of the final standard MOU, a pharmacy has distributed
an inordinate amount of compounded human drug products interstate if
the number of prescription orders for compounded human drug products
that the pharmacy distributed interstate during any calendar year is
greater than 50 percent of the sum of the number of prescription orders
for compounded human drug products that the pharmacy sent out of (or
caused to be sent out of)

the facility in which the drug products were compounded during that
same calendar year and the number of prescription orders for compounded
human drug products that were dispensed (e.g., picked up by a patient)
at the facility in which they are compounded during that same calendar
year (Fig. 1). This concept is called the 50 percent threshold.
[GRAPHIC] [TIFF OMITTED] TN27OC20.000

    The final standard MOU provides that State Boards of Pharmacy or
other appropriate State agencies that enter into the MOU will agree to:
     On an annual basis, identify, using surveys, reviews of
records during inspections, data submitted to an Information Sharing
Network, or other mechanisms available to the State Board of Pharmacy
or other appropriate State agency, pharmacies that distribute
inordinate amounts of compounded human drug products interstate.
     For pharmacies that have been identified as distributing
inordinate amounts of compounded human drug products interstate during
any calendar year, the State Board of Pharmacy or other appropriate
State agency will identify, using data submitted to the Information
Sharing Network or other available mechanisms, during that same
calendar year:
    [cir] The total number of prescription orders for sterile
compounded human drug products distributed interstate;
    [cir] The names of States in which the pharmacy is licensed;
    [cir] The names of States into which the pharmacy distributed
compounded human drug products; and,
    [cir] Whether the State inspected for and found during its most
recent inspection that the pharmacy distributed compounded human drug
products without valid prescription orders for individually identified
patients.
     Within 30 business days of identifying a pharmacy that has
distributed inordinate amounts of compounded human drug products
interstate, the State Board of Pharmacy or other appropriate State
agency will notify FDA, by submission to an Information Sharing Network
or by email to<EMAIL_ADDRESS>and will include the following
information:
    [cir] Name and address of the pharmacy that distributed inordinate
amounts of compounded human drug products interstate;
    [cir] The number of prescription orders for compounded human drug
products that the pharmacy sent out of (or caused to be sent out of)
the facility in which the drug products were compounded during that
same calendar year;
    [cir] The number of prescription orders for compounded human drug
products that were dispensed (e.g., picked up by a patient) at the
facility in which they are compounded during that same calendar year;
    [cir] Total number of prescription orders for compounded human drug
products distributed interstate during that same calendar year;
    [cir] Total number of prescription orders for sterile compounded
human drug products distributed interstate during that same calendar
year;
    [cir] The names of States in which the pharmacy is licensed as well
as the names of States into which the pharmacy distributed compounded
human drug products during that same calendar year; and
    [cir] Whether the State Board of Pharmacy or other appropriate
State agency inspected for and found during its most recent inspection
that the pharmacy distributed compounded human drug products without
valid prescriptions for individually identified patients during that
same calendar year.
     If the State Board of Pharmacy or other appropriate State
agency becomes aware of a physician who is distributing any amount of
compounded human drug products interstate, it will notify the
appropriate regulator of physicians within the State. The State Board
of Pharmacy or other appropriate State agency will, within 30 days of
identifying a physician who is distributing any amount of compounded
human drug products interstate, also notify FDA by submission to an
Information Sharing Network or by email to<EMAIL_ADDRESS>    Section 503A of the FD&C Act reflects Congress' recognition that
compounding may be appropriate when it is based on receiving a valid
prescription order or notation approved by the prescribing practitioner
for an identified individual patient. However, drug products compounded
under section 503A are not required to demonstrate that they are safe
or effective, have labeling that bears adequate directions for use, or

conform to CGMP. Congress, therefore, imposed strict limitations on the
distribution of drug products compounded under section 503A to protect
the public health and the integrity of the drug approval process.
    In particular, Congress did not intend for compounders operating
under these statutory provisions to grow into conventional
manufacturing operations making unapproved drugs, operating a
substantial proportion of their business interstate, without adequate
oversight. Although other provisions of the FD&C Act (e.g., the
adulteration provisions regarding drugs prepared, packed, or held under
insanitary conditions) apply to drugs compounded by State-licensed
pharmacies and physicians that may qualify for the exemptions under
section 503A of the FD&C Act, and although FDA may take action in
appropriate cases against compounders whose drugs violate these
provisions or that operate outside of the conditions in section 503A,
Congress recognized that these compounders are primarily overseen by
the States. However, if a substantial proportion of a compounder's drug
products are distributed outside a State's borders, adequate regulation
of those drug products poses significant challenges to State
regulators. States face logistical, regulatory, and financial
challenges inspecting compounders located outside of their
jurisdiction. In addition, if a compounder distributes drug products to
multiple States, it can be very difficult to gather the scattered
information about possible adverse drug experiences or product quality
issues associated with those drug products, connect them to the
compounder, and undertake coordinated action to address a potentially
serious public health problem.
    Therefore, as a baseline measure, section 503A(b)(3)(B)(ii) of the
FD&C Act limits the distribution of compounded drug products outside of
the State in which they are compounded to 5 percent of the total
prescription orders dispensed or distributed by a licensed pharmacist,
pharmacy, or physician. It then directs FDA, in consultation with NABP,
to develop a standard MOU that addresses the distribution of inordinate
amounts of compounded drug products interstate and provides for
appropriate investigation by a State agency of complaints relating to
drug products compounded in and distributed outside such State.
Development of the standard MOU involves FDA describing what inordinate
amounts means and providing a mechanism for addressing distribution of
inordinate amounts of compounded human drug products interstate, as
long as the State agrees to appropriately investigate complaints
relating to drug products compounded in and distributed out of the
State. The 5 percent limitation in section 503A(b)(3)(B)(ii) does not
apply to drug products compounded in a State that has entered into the
standard MOU under section 503A(b)(3)(B)(i).
    In the 2015 draft standard MOU, FDA proposed that distribution
interstate up to a 30 percent limit would not be inordinate, and that
States entering into the MOU would agree to take action regarding
pharmacists, pharmacies, or physicians that distribute inordinate
amounts of compounded drug products interstate. FDA received a number
of comments indicating that certain pharmacies, such as pharmacies
located near State borders and home infusion pharmacies, distribute
more than 30 percent of their compounded human drug products to
patients interstate because, for example, the patients are located in
another nearby State, or because few pharmacies compound a particular
drug product to treat an uncommon condition for patients dispersed
throughout the country. The comments noted that the proposed definition
of inordinate amounts and the proposed provision in which States agree
to take action could prevent such pharmacies from fulfilling patients'
medical needs for the drug products that they supply. Other comments
expressed concern about instances in which pharmacies are located near
a State border and distribute compounded drug products to the other
side of that border. FDA also received general comments questioning the
Agency's basis for the 30 percent limit and indicating that it was too
low. Some comments suggested that FDA increase the limit, including a
suggestion to increase it to 50 percent.
    The 2018 revised draft standard MOU addressed these comments in two
respects. First, it removed the provision in the 2015 draft standard
MOU that States agree to take action with respect to the distribution
of inordinate amounts of compounded human drug products interstate.
Second, it changed what is considered ``inordinate amounts'' from a 30
percent limit to a 50 percent threshold. In the final standard MOU, the
States are not agreeing to take action with respect to distribution of
inordinate amounts of compounded human drug products interstate, but,
instead, to notify FDA of pharmacies that have distributed an
inordinate amount of compounded human drug products interstate. The
Agency does not intend to take action against a pharmacy located in a
State that has entered into the MOU solely because the pharmacy has
exceeded the threshold for inordinate amounts. Rather, the State Board
of Pharmacy or other appropriate State agency entering into the final
standard MOU agrees to collect further information on pharmacies that
have distributed inordinate amounts interstate and provide this
information to FDA to help inform Agency inspectional priorities. The
State Board of Pharmacy or other appropriate State agency also agrees
to notify FDA and the appropriate state regulator of physicians if it
becomes aware of physicians distributing any amount of compounded human
drug products interstate.
    We note that States generally have day-to-day oversight
responsibilities over State-licensed pharmacies, pharmacists, and
physicians. In general, FDA considers a State-licensed pharmacy or
physician to be primarily overseen by the State, which is responsible
both for regulation of the compounder and protection of its citizens
who receive the compounded drug products. However, as discussed above,
if a substantial proportion of a compounder's drug products is
distributed outside a State's borders, adequate regulation of those
drugs poses significant challenges to State regulators. In such cases,
although State oversight continues to be critical, additional oversight
by FDA may afford an important public health benefit.
    As stated above, the final standard MOU uses 50 percent as the
threshold beyond which the amount of compounded human drug products
distributed interstate by a pharmacy would be considered inordinate.
The 50 percent threshold is the threshold that, with regard to
pharmacies, triggers an information identification and reporting
obligation once it is reached. The Agency believes that more than 50
percent is an appropriate measure of ``inordinate amounts'' because it
marks the point at which pharmacies are distributing the majority of
their compounded human drug products interstate, and the regulatory
challenges associated with interstate distributors discussed above
become more pronounced. At this point, the risk posed by the
distribution practices of the compounder may weigh in favor of
additional Federal oversight in addition to State oversight.
    FDA recognizes that, in some cases, pharmacies may distribute more
than 50 percent of a small quantity of compounded human drug products
to contiguous States. Although such pharmacies have exceeded the
inordinate amounts threshold in the final standard MOU, FDA would

consider other information, such as the number of patients that will
receive the compounded human drug products, if available, when
assessing the pharmacy's priority for risk-based inspection.
Accordingly, when a State Board of Pharmacy or other appropriate State
agency identifies a pharmacy that distributes an inordinate amount of
compounded human drug products interstate, the final standard MOU
provides that the State entity will supply the Agency with certain
information as described above. In addition, if the State Board of
Pharmacy or other appropriate State agency becomes aware of a physician
who is distributing any amount of compounded human drug products
interstate, the State entity will notify both the appropriate regulator
of physicians within the State and FDA. FDA intends to use this
information to prioritize its oversight of compounders based on risk,
focusing on those that appear likely to distribute large volumes of
compounded human drug products, particularly when the distribution is
to multiple States, the drug products are intended to be sterile, and
there is information about a lack of valid prescriptions for
individually identified patients.
    The calculation of inordinate amounts in the final standard MOU,
with clarifying changes to the language, is the same as the calculation
proposed in the 2018 revised draft standard MOU, with the exception of
a change in the timeframe used in the calculation from 1 month to 1
year and removing drugs compounded by physicians from the calculation
made by the State Board of Pharmacy or other appropriate State agency.
The 2015 draft standard MOU provided that a compounder is considered to
have distributed an inordinate amount of compounded drug products
interstate if the number of units of compounded drug products
distributed interstate during any calendar month is equal to or greater
than 30 percent of the number of units of compounded and non-compounded
drug products distributed or dispensed both intrastate and interstate
by such compounder during that calendar month. FDA received comments
noting that because the calculation includes both compounded and non-
compounded drug products, in many cases, a substantial factor in
whether a compounder has distributed an inordinate amount of compounded
drug products interstate is whether the compounder offers non-
compounded drug products. For example, under that policy, many
specialty compounding pharmacies that engage in distribution of
compounded human drug products interstate and only distribute
compounded drug products would be able to distribute fewer compounded
drug products interstate before reaching an inordinate amount than a
pharmacy that also fills prescriptions for non-compounded drug
products, even if both pharmacies produced the same amount of
compounded drug products. After considering the public comments, FDA
does not believe that including non-compounded drug products within the
calculation of inordinate amounts would help address the public health
concerns associated with sending compounded human drug products
interstate that Congress sought to address in section 503A(b)(3)(B) of
the FD&C Act. Non-compounded drug products were excluded from the
calculation of inordinate amounts in the 2018 revised draft MOU. This
final standard MOU maintains this exclusion.\2\ FDA removed drug
products compounded by physicians from the inordinate amount
calculation to clarify that the State Board of Pharmacy or other
appropriate State agency signing the MOU does not agree to gather
information about the distribution of compounded drug products
interstate by physicians or to calculate inordinate amounts of drug
products compounded by a physician and distributed interstate. Instead,
the State Board of Pharmacy or other appropriate State agency signing
the MOU agrees that if it becomes aware that a physician is
distributing any amount of compounded human drug products interstate it
will notify the State authority that regulates physicians and FDA. This
focus on States calculating inordinate amounts of pharmacy compounding
reflects FDA's understanding and feedback from State regulators that
the distribution interstate of compounded drug products mainly involves
pharmacy compounders.
---------------------------------------------------------------------------

    \2\ FDA also intends to exclude non-compounded drugs from the
calculation of the 5 percent limit in section 503A(b)(3)(B)(ii).
---------------------------------------------------------------------------

    FDA received comments on the 2018 revised draft MOU expressing
concern about calculating inordinate amounts by calendar month. After
considering these comments and recognizing the possibility for
significant monthly fluctuations, we have provided for annual
calculation of inordinate amounts in the final standard MOU.
    This 50 percent threshold does not function as a limit on the
distribution of compounded human drug products interstate, but,
instead, is a threshold for triggering information gathering about
pharmacy distribution of compounded drugs by the State Board of
Pharmacy or other appropriate State agency and provision to FDA. The
information gathered will be considered by the Agency for the purpose
of helping to inform its risk-based inspection priorities.

C. Definitions

    Appendix A retains the definitions of ``adverse drug experience,''
``serious adverse drug experience,'' ``product quality issue,'' and
``serious product quality issue'' from the 2018 revised draft standard
MOU.
    To clarify the meaning of ``distribution of inordinate amounts of
compounded drug products interstate,'' the proposed definition of
``distribution'' in the 2018 revised draft standard MOU has been
omitted and ``distribution of compounded human drug products
interstate'' and ``inordinate amounts'' are defined. ``Distribution of
compounded human drug products interstate'' means that a pharmacy or
physician has sent (or caused to be sent) a compounded drug product out
of the state in which the drug was compounded. A pharmacy has
distributed an ``inordinate amount'' of compounded human drug products
interstate if the number of prescription orders for compounded human
drug products that the pharmacy distributed interstate during any
calendar year is greater than 50 percent of the sum of: (1) The number
of prescription orders for compounded human drug products that the
pharmacy sent out of (or caused to be sent out of) the facility in
which the drug products were compounded during that same calendar year;
plus (2) the number of prescription orders for compounded human drug
products that were dispensed (e.g., picked up by a patient) at the
facility in which they were compounded during that same calendar year.
    We received a number of comments on the 2015 draft standard MOU and
the 2018 revised draft standard MOU stating that distributing and
dispensing are mutually exclusive activities, such that if a drug
product is distributed, it is not also dispensed, and vice versa. Some
comments asserted, in particular, that a compounded drug product should
not be considered to be ``distributed'' when it is provided pursuant to
a prescription. Other stakeholders, however, agreed with the inclusion
of drug products provided pursuant to a prescription within the
definition of ``distribution'' and maintained that this interpretation
was important to protect the public health.
    After considering these comments and the public health objectives
of section 503A(b)(3)(B) of the FD&C Act, FDA

considers that when a drug is picked up at the facility in which it was
compounded, dispensing, but not distribution, occurs for purposes of
503A(b)(3)(B).
    FDA believes that in-person dispensing, where the transaction
between the compounder and the patient is completed at the facility in
which the drug product was compounded, is appropriately overseen,
primarily, by the State outside the context of the MOU, regardless of
whether the compounded drug product subsequently leaves the State. Such
an intrastate, local transaction generally indicates a close connection
among the patient, compounder, and prescriber. By contrast,
transactions by mail often have a less direct nexus among the patient,
compounder, and prescriber than in-person pick-ups and would be
considered ``distribution.''
    Drugs dispensed in-person that are later taken out of State will
not contribute to reaching the threshold for inordinate amounts under
the final MOU. Nor will complaints associated with compounded drug
products dispensed this way and subsequently taken out of State be
subject to the complaint investigation provisions of the final MOU. FDA
expects that, in practice, the State in which the initial transaction
occurred would handle such complaints. The State may, in its
discretion, notify FDA of the complaint.
    FDA is not persuaded by comments urging the Agency to interpret
``distribution'' and ``dispensing'' to be entirely separate activities
for purposes of section 503A(b)(3)(B) of the FD&C Act. These comments
recommend using definitions for these terms used elsewhere in the FD&C
Act and FDA regulations, and generally conclude that distribution does
not include the transfer of a drug pursuant to a prescription.
    The conditions in section 503A, including section 503A(b)(3)(B),
must be interpreted consistent with the prescription requirement in
section 503A(a) of the FD&C Act. If we were to interpret the word
``distribution'' to apply only if a drug is provided without a
prescription, it would mean that drug products compounded under section
503A of the FD&C Act are excluded from regulation under the MOU and the
5 percent limit, because to qualify for the exemptions under section
503A, a compounder must obtain a valid prescription order for an
individually identified patient. For the reasons stated previously in
this document, we believe this would achieve the opposite of what
Congress intended. A compounded drug product may be eligible for the
exemptions under section 503A of the FD&C Act only if it is, among
other things, ``compounded for an identified individual patient based
on the receipt of a valid prescription order or a notation, approved by
the prescribing practitioner, on the prescription order that a
compounded product is necessary for the identified patient.''
    Nor is there anything to suggest that Congress understood
``distributed'' and ``dispensed'' to be mutually exclusive categories
rather than overlapping categories for purposes of section 503A.
Section 503A(b)(3)(B) of the FD&C Act does not define ``distribution''
to exclude dispensing, which Congress has done elsewhere when that was
its intention.\3\ The definition proposed by comments would write an
exclusion for dispensing, in its entirety, into the statute where
Congress did not. Indeed, with respect to comments suggesting that
drugs dispensed pursuant to prescriptions could not also be
``distributed,'' we note that, in section 503A(b)(3)(B), Congress
specifically contemplated that prescription orders could be
``distributed'' when it directed the Agency to count the number of
prescription orders that pharmacists and prescribers distributed.
---------------------------------------------------------------------------

    \3\ In other (non-compounding) contexts, where it would further
a regulatory purpose, Congress and the Agency have specifically
defined ``distribute'' to exclude dispensing. See, for example,
section 581(5) of the FD&C Act (21 U.S.C. 360eee(5)), which applies
to Title II of the DQSA, and 21 CFR 208.3, which applies to 21 CFR
part 208. Section 503A of the FD&C Act does not contain a similar
definition, or a similar specific direction to exclude dispensing
from the meaning of distribution. We also note that these
definitions were adopted for provisions that focus on conventionally
manufactured drug products, which assign different obligations to
dispensers than to wholesalers, packagers, or other intermediaries
in light of the different role that dispensers play with respect to
product labeling and the drug distribution chain. In contrast,
section 503A of the FD&C Act focuses on compounded drugs, and the
reasons for defining ``distribution'' to exclude dispensing in Title
II of the DQSA or part 208 do not apply.
---------------------------------------------------------------------------

IV. Other Issues

A. Authority of State Boards of Pharmacy or Other Appropriate State
Agencies

    The 2018 revised draft standard MOU proposed that ``States'' would
be the signatories of the MOU. In the final standard MOU, FDA clarifies
the State party to the agreement, which is described as the ``State
Board of Pharmacy or other appropriate State agency.'' FDA received
comments expressing concerns that the State entity signing the MOU
(e.g., the State Board of Pharmacy) may not have regulatory authority
over physician compounding and could not agree to the MOU provisions
regarding physicians as they appeared in the 2018 revised draft
standard MOU. With regard to physician compounding, FDA has revised
certain provisions from the 2018 revised draft standard MOU. Under the
final standard MOU, a State Board of Pharmacy or other appropriate
State agency would enter into the MOU on behalf of the State and agree
to (1) notify FDA and the appropriate regulator of physicians within
the State when it receives a complaint about adverse drug experiences
or product quality issues associated with a human drug product
compounded by a physician and distributed outside the State; and (2) if
it becomes aware of a physician distributing any amount of compounded
human drug products interstate, notify FDA and the appropriate
regulator of physicians within the State.

B. Physician Compounding

    It is FDA's understanding that physicians who compound drugs
generally do so for their own patients, within their own professional
practice, and provide them intrastate. FDA believes that, generally,
physicians are not engaged in compounding that results in routine
distribution of compounded drug products interstate.
    Additionally, several comments advised that State Boards of
Pharmacy do not oversee physician compounding and would not be able to
agree to the provisions under the 2018 revised draft standard MOU with
respect to oversight of physician compounding (collecting additional
information to identify whether a physician compounder is distributing
inordinate amounts of compounded drug products interstate, etc.).
Accordingly, under the final standard MOU, State Boards of Pharmacy or
other appropriate State agencies would agree to (1) notify FDA and the
appropriate regulator of physicians within the State when they receive
complaints about adverse drug experiences or product quality issues
associated with a human drug product compounded by a physician and
distributed outside the State; and (2) if they become aware of a
physician distributing any amount of compounded human drug products
interstate, notify FDA and the appropriate regulator of physicians
within the State. The information provided to FDA will help inform
Agency inspectional priorities with respect to physicians who compound
human drug products and provide information to State regulators of
physicians for appropriate action.

C. Development of a Standard MOU

    A number of comments on the 1999 draft standard MOU, the 2013 draft
503A guidance, the 2015 draft standard MOU, and the 2018 revised draft
MOU suggested that FDA negotiate MOUs with individual States, rather
than develop a standard MOU. Section 503A of the FD&C Act requires the
Agency to develop a standard MOU for use by the States. Furthermore, it
would be impractical to develop an individualized MOU with every State,
and creating individualized MOUs would create a patchwork of regulation
of distribution of compounded human drug products interstate by
compounders seeking for their drug products to qualify for the
exemptions under section 503A of the FD&C Act. This would be confusing
to the healthcare community, as well as regulators.

D. Exemptions From the Provisions Related to Distribution of Inordinate
Amounts of Compounded Human Drug Products Interstate

    Some comments on the 2013 draft 503A guidance, the 2015 draft
standard MOU, and the 2018 revised draft standard MOU requested that we
consider exempting certain drug products or types of compounding
entities from the threshold in the MOU and the 5 percent limit. For
example, some comments recommended that we exempt nonsterile products.
    American consumers rely on the FDA drug approval process to ensure
that medications have been evaluated for safety and effectiveness
before they are marketed in the United States. Drugs made by
compounders, including those made at outsourcing facilities, are not
FDA-approved. This means that they have not undergone premarket review
of safety, effectiveness, or manufacturing quality. Therefore, when an
FDA-approved drug is commercially available, FDA recommends that
practitioners prescribe the FDA-approved drug rather than a compounded
drug product unless the prescribing practitioner has determined that a
compounded product is necessary for the particular patient and would
provide a significant difference for the patient as compared to the
FDA-approved commercially available drug product.
    In section 503A of the FD&C Act, Congress enacted several
conditions to differentiate compounders from conventional manufacturers
and provided that only if the compounders meet those conditions can
they qualify for the exemptions from the drug approval requirements in
section 505 of the FD&C Act. One of those conditions relates to
limitations and other measures to address distribution of compounded
drug products interstate, and FDA intends to enforce those provisions
to differentiate compounding that qualifies for the exemptions from
conventional manufacturing in the guise of compounding that does not
and will apply the conditions to all types of drugs and all categories
of compounding.

E. Information Sharing Between the State Boards of Pharmacy or Other
Appropriate State Agencies and FDA

    The final standard MOU provides that State Boards of Pharmacy or
other appropriate State agencies will agree to notify FDA of a
complaint relating to a compounded human drug product distributed
outside the State involving a serious adverse drug experience or
serious product quality issue and provide information about those
experiences and issues. The final standard MOU also provides that State
Boards of Pharmacy or other appropriate State agencies will notify FDA
if they identify a pharmacy that has distributed inordinate amounts of
compounded human drug products interstate. In addition, State Boards of
Pharmacy or other appropriate State agencies will notify FDA and the
appropriate regulator of physicians within the State if the State
entity becomes aware of a physician who is distributing any amount of
compounded human drug products interstate, or if the State entity
receives a complaint involving an adverse experience or product quality
issue relating to a human drug product compounded by a physician and
distributed outside the State.
    FDA has entered into a cooperative agreement with NABP to establish
an information sharing network that is intended to, in part, facilitate
State information reporting to FDA by State Boards of Pharmacy or other
appropriate State agencies that enter into the MOU with FDA addressing
distribution of compounded drugs interstate.\4\ The goal of this
information-sharing and research initiative is to improve the
management and sharing of information available to State regulators and
FDA regarding State-licensed compounders and the distribution of
compounded human drug products interstate to support better and more
targeted regulation and oversight of compounding activities to help
reduce risk to patients. This information will be important to help
States to focus their limited resources on compounders for which they
have primary oversight responsibility that present the greatest risk.
It will also facilitate FDA's ability to determine when additional
Federal oversight is warranted, such as when a large-scale compounder
distributes drug products to multiple States, potentially causing
significant and widespread harm if its products are substandard. FDA
expects that the information sharing network will be designated by FDA
for purposes of the MOU to collect, assess, and allow review and
sharing of information pursuant to the MOU. FDA regularly posts, on its
compounding website, information about enforcement and other actions
related to compounders that violate the FD&C Act, and it is obligated
to share certain information with States under section 105 of the DQSA.
In addition to these measures, FDA is taking steps to proactively share
information with States about complaints that it receives regarding
compounded drug products, consistent with Federal laws governing
information disclosure.
---------------------------------------------------------------------------

    \4\ See RFA-FD-19-025, available at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-19-025.html.
---------------------------------------------------------------------------

F. Enforcement of the 5 Percent Limit on Distribution of Compounded
Human Drug Products Out of the State in Which They Are Compounded

    In the 2013 draft 503A guidance, FDA stated that it does not intend
to enforce the 5 percent limit on distribution of compounded human drug
products outside of the State in which they are compounded until 90
days after FDA has finalized a standard MOU and made it available to
the States for their consideration and signature. Most comments on the
2013 draft 503A guidance that raised this issue said this period was
too short but did not recommend a specific alternative. A few comments
recommended a different timeframe, one recommending 120 days and
another recommending 365 days. The 1997 Senate Committee Report for the
Food and Drug Administration Modernization Act suggests that a 180-day
period for States to decide whether to sign might be appropriate.\5\ In
the notice of availability for the 2018 revised draft standard MOU,
consistent with the 2015 draft standard MOU, the Agency proposed a 180-
day period after

the final standard MOU is made available for signature before FDA will
enforce the 5 percent limit in States that have not signed the MOU, and
invited public comment on whether this was an appropriate timeframe.
Some commenters on the 2018 revised draft standard MOU stated that more
time may be necessary because some States may be required to enact new
laws and promulgate new regulations before entering the MOU. Therefore,
in response to these comments, FDA is providing a 365-day period for
States to decide whether to sign the MOU before FDA intends to begin
enforcing the 5 percent limit in States that do not sign. It is FDA's
understanding that this extended timeframe corresponds to a full
legislative cycle for most States and should, therefore, afford
sufficient time for States to modify their laws and regulations, if
necessary.
---------------------------------------------------------------------------

    \5\ ``[U]ntil the State . . . enters into a memorandum of
understanding (MOU) with the Secretary or 180 days after the
development of the standard MOU, whichever comes first, the [section
503A] exemption shall not apply if inordinate quantities of
compounded products are distributed outside of the State in which
the compounding pharmacy or physician is located.'' (U.S. Senate
Committee Report)
---------------------------------------------------------------------------

V. Paperwork Reduction Act of 1995

    This MOU refers to previously approved collections of information.
These collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3521). The collections of information have been
approved under OMB control number 0910-0800.

VI. Electronic Access

    Persons with access to the internet may obtain the final standard
MOU at either https://www.fda.gov/drugs/human-drug-compounding/regulatory-policy-information, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.regulations.gov.

    Dated: October 21, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23687 Filed 10-26-20; 8:45 am]
BILLING CODE 4164-01-P