[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Proposed Rules]
[Pages 49501-49503]
[FR Doc No: 2021-15903]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R01-OAR-2021-0443; FRL-8778-01-R1]

Approval and Promulgation of State Plan for Designated Facilities
and Pollutants: New Hampshire; 111(d)/129 Revised State Plan for
Existing Large and Small Municipal Waste Combustors

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve the Clean Air Act (CAA) state plan revision for existing large
and small municipal waste combustors (MWCs) submitted by the New
Hampshire Department of Environmental Services (NHDES) on October 1,
2018. The revised state plan incorporates wood residue combustion fuel
quality standards and test methods at MWC facilities that process and
combust construction and demolition debris.

DATES: Written comments must be received on or before October 4, 2021.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R01-OAR-2021-0443 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets. Publicly
available docket materials are available at https://www.regulations.gov
or at the U.S. Environmental Protection Agency, EPA Region 1 Regional
Office, Air and Radiation Division, 5 Post Office Square--Suite 100,
Boston, MA. EPA requests that if at all possible, you contact the
contact listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding
legal holidays and facility closures due to COVID-19.

FOR FURTHER INFORMATION CONTACT: Jessica Kilpatrick, Air Permits,
Toxics, & Indoor Programs Branch, Air and Radiation Division, U.S.
Environmental Protection Agency, Region 1, 5 Post Office Square, Mail
Code: 05-2, Boston, MA 02109-0287. Telephone:<PHONE_NUMBER>. Fax: 617-
918-0652 Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. What is a state plan?
II. Why does EPA need to approve state plans?
III. Why does EPA regulate air emissions from MWCs?
IV. What history does NHDES have with MWC state plans?
V. Why did NHDES revise the MWC state plan?
VI. What revisions have been made to the state plan?
VII. Why is EPA proposing to approve NHDES's revised state plan?
VIII. Proposed Action
IX. Incorporation by Reference
X. Statutory and Executive Order Reviews

I. What is a state plan?

    Section 111(d) of the CAA requires pollutants controlled under new
source performance standards (NSPS) also be controlled at existing
sources in the same source category. Once an NSPS is issued, EPA then
publishes emission guidelines (EGs) applicable to the control of the
same pollutant for existing (designated) facilities. States with
designated facilities must develop state plans to adopt the EGs into
their body of regulations. States must also include in their state
plans other elements, such as legal authority, inventories, and public
participation documentation to demonstrate their ability to enforce the
state plans.

II. Why does EPA need to approve state plans?

    Section 129(b)(2) of the CAA requires states to submit state plans
to EPA for approval. Each state must show that its state plan will
carry out and enforce the EGs. State plans must be at least as
protective as the EGs and will become

federally enforceable upon EPA's approval. The procedures for adopting
and submitting state plans are in 40 CFR part 60, subpart B.

III. Why does EPA regulate air emissions from MWCs?

    EPA is required to regulate air emissions from MWCs under sections
111(d) and 129 of the Clean Air Act. Large municipal waste combustors
(LMWCs) are capable of combusting more than 250 tons per day of solid
waste, while small municipal waste combustors (SMWCs) are capable of
combusting at least 35 tons per day, but no more than 250 tons per day
of municipal solid waste or refuse-derived fuel. When burned, municipal
solid wastes emit various air pollutants, including particulate matter,
hydrogen chloride, dioxins/furans, heavy metals (lead, cadmium, and
mercury), sulfur dioxide, and nitrogen oxides. Exposure to particulate
matter can aggravate existing respiratory and cardiovascular disease as
well as increase risk of premature death. Chronic exposure to hydrogen
chloride has been reported to cause gastritis, chronic bronchitis,
dermatitis, and photosensitization. Acute exposure to high levels of
chlorine in humans may result in chest pain, vomiting, toxic
pneumonitis, pulmonary edema, and death. At lower levels, chlorine is a
potent irritant to the eyes, the upper respiratory tract, and lungs.
Exposure to dioxin and furan can cause skin disorders, cancer, and
reproductive effects such as endometriosis. These pollutants can also
affect the immune system.
    Mercury is highly hazardous and is of particular concern because it
persists in the environment and bioaccumulates through the food web.
Serious human health effects, primarily to the nervous system, have
been associated with exposures to mercury. Harmful physiological
impacts on wildlife have also been reported; these include nervous
system damage and behavioral and reproductive deficits. Human and
wildlife exposure to mercury occur mainly through ingestion of fish.
When inhaled, mercury vapor attacks the lung tissue and is a cumulative
poison. Short-term exposure to mercury in certain forms can cause
hallucinations and impair consciousness. Long-term exposure to mercury
in certain forms can affect the central nervous system and cause kidney
damage.

IV. What history does NHDES have with MWC state plans?

    EPA approved NHDES's sections 111(d)/129 state plan for existing
large and small MWCs on February 10, 2003, effective on April 11, 2003.
The state plan establishes the operating and performance standards for
MWCs with the capacity to combust greater than 35 tons per day of
municipal solid waste, to comply with CAA sections 111(d) and 129 as
well as State rules promulgated under the New Hampshire Code of
Administrative Rules Env-A 3300 Municipal Waste Combustion. Since its
approval, the state plan has been amended twice. On January 29, 2009,
NHDES submitted a revision to comply with EPA's revised regulations for
LMWCs via 40 CFR part 60, subpart Cb, Emissions Guidelines and
Compliances for Large Municipal Waste Combustors that are Constructed
on or Before September 20, 1994. EPA approved these revisions on
September 3, 2014. See 79 FR 52204. The second revision was submitted
by NHDES on July 28, 2016, to align standards for SMWCs with those of
LMWCs. EPA proposed these revisions on June 6, 2017. See 82 FR 25972.

V. Why did NHDES revise the MWC state plan?

    EPA's February 8, 2016 revision to 40 CFR part 241, subpart B,
Identification of Non-Hazardous Secondary Materials that are Solid
Wastes when Used as Fuels or Ingredients in Combustion Units, added
construction and demolition (C&D) wood processed from C&D debris
according to best management practices to its categorical list of non-
waste fuels. (See 81 FR 6743). Subsequently on August 11, 2018, NHDES
removed a ban on wood residue combustion via the state statute RSA 125-
C:10-c(II)(b) Combustion Ban. The change allows combustion of no more
than 10,000 tons per year of wood residue at any large municipal waste
combustor from November 15 through April 15 from facilities that
process construction and demolition debris in a manner no less
stringent than the requirements at 40 CFR 241.4(a)(5), Non-Waste
Determinations for Specific Non-Hazardous Secondary Materials When Used
as a Fuel. The change also requires NHDES to adopt rules regarding fuel
quality standards and test methods in accordance with RSA 125-C:6, XIV-
a before any such combustion shall occur, therefore this state plan
revision is a necessity. The change was initiated in 2016, and it was
introduced by the NHDES Air Resources Division and the Solid Waste
Division at multiple stakeholder meetings open to the public with
opportunities for comment. The proposed rule was presented to the NHDES
Air Resources Council on September 11, 2017, and the final rule was
posted for notice on May 14, 2018, with a public hearing on June 15,
2018, a comment period ending on June 29, 2018, and an effective date
of September 27, 2018.

VI. What revisions have been made to the state plan?

    On October 1, 2018, NHDES submitted the sections 111(d)/129 revised
state plan for existing large and small municipal waste combustors to
EPA. The revision incorporates fuel quality standards and test methods
for wood residue at MWC facilities that process C&D wood debris. The
revised state plan includes changes to Env-A 3300, defining processed
wood residue (PWR) as construction and demolition wood that has
undergone positive or negative sorting in accordance with the best
management practices as described in 40 CFR 241.4(a)(5). The state plan
revision also includes new part Env-A 3308 Additional Requirements for
Combusting PWR with sections outlining applicability, operating
practices, PWR fuel quality, fuel supplier requirements, independent
third-party inspections, analysis of compositive samples, reporting and
recordkeeping for LMWCs combusting PWR, and cessation and resumption of
receipt of PWR from a supplier.

VII. Why is EPA proposing to approve NHDES's revised state plan?

    EPA has evaluated NHDES's sections 111(d)/129 revised state plan
for existing large and small MWCs for consistency with the CAA, EPA
guidelines, and policy. C&D wood is a non-hazardous secondary material
that is not classified as a solid waste when used as a fuel in a
combustion unit and is regulated by Env-A 3300, which EPA finds to be
no less stringent than 40 CFR 241.4(a)(5).
    Furthermore, the quantity of PWR New Hampshire's existing large
MWCs are allowed to combust ensures that the units do not meet the
definition of a cofired combustor and thus become exempt from Federal
regulations for large MWCs. Cofired combustors, defined as MWC units
combusting municipal solid waste with nonmunicipal solid waste fuel,
that have a federally enforceable permit limiting municipal solid waste
combustion to 30 percent of the total fuel input by weight, are exempt
from large MWC emission guidelines and Federal Plan. See 40 CFR
60.32b(i), 60.50a(d), 60.50b(j), 60.1020(g), 60.1555(g), 62.14102(j),
and 62.15020(g). By limiting the combustion of no more than 10,000 tons
per year of PWR at any MWC from November 15 through April 15, and
further restricting combustion of

the material from November 15 through April 15, it is impossible for a
large MWC (with a daily capacity rating of no less than 250 tons per
day) to meet the definition of a cofired combustor. Therefore, EPA has
concluded that the state plan revision meets all requirements,
including compliance with Federal regulations.
    EPA is proposing to approve NHDES's state plan revision based on
our analysis above and our findings that NHDES provided adequate public
notice of public hearings for the proposed rulemaking that allows NHDES
to carry out and enforce provisions that are at least as protective as
the Federal emission guidelines for large and small MWCs. Furthermore,
NHDES demonstrates legal authority to adopt emission standards and
compliance schedules applicable to the designated facilities; enforce
applicable laws, regulations, standards and compliance schedules; seek
injunctive relief; obtain information necessary to determine
compliance; require record keeping; conduct inspections and tests;
require the use of monitors; require emission reports of owners and
operators; and make emission data publicly available.

VIII. Proposed Action

    EPA is proposing to approve NHDES's sections 111(d)/129 revised
State plan for existing large and small MWCs. EPA is soliciting public
comments on the issues discussed in this notice or on other relevant
matters. These comments will be considered before taking final action.
Interested parties may participate in the Federal rulemaking procedure
by submitting written comments to this proposed rule by following the
instructions listed in the ADDRESSES section of this Federal Register
document.

IX. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the State of New Hampshire Amendments to the sections 111(d)/
129 State Plan for Municipal Waste Combustion, dated October 1, 2018.
NHDES amends New Hampshire's Code of Administrative Rules Env-A 3300,
Municipal Waste Combustion, effective September 27, 2018, regarding MWC
units as discussed in Section VI of this preamble. The EPA has made,
and will continue to make, these documents generally available through
https://www.regulations.gov and at the EPA Region 1 Office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information).

X. Statutory and Executive Order Reviews

    Under section 129 of the Clean Air Act, the Administrator is
required to approve a state plan submission that complies with the
provisions of the Act and applicable Federal regulations. 42 U.S.C.
7429(b); 40 CFR 60.27. Thus, in reviewing state plan submissions, EPA's
role is to approve state choices, provided that they meet the criteria
of the Clean Air Act. Accordingly, this proposed action merely approves
state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the revised state plan is not approved to apply on any
Indian reservation land or in any other area where EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

List of Subjects in 40 CFR Part 62

    Environmental protection, Air pollution control, Administrative
practice and procedure, Incorporation by reference, Industrial
facilities, Intergovernmental relations, Reporting and recordkeeping
requirements, Sulfur oxides, Waste treatment and disposal.

    Dated: July 20, 2021.
Deborah Szaro,
Acting Regional Administrator, EPA Region 1.
[FR Doc. 2021-15903 Filed 9-2-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 150 (Monday, August 9, 2021)]
[Notices]
[Page 43572]
[FR Doc No: 2021-16906]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-61, OMB Control No. 3235-0073]

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

Extension:
    Form S-3

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget request for extension of the previously approved collection
of information discussed below.
    Form S-3 (17 CFR 239.13) is used by issuers to register securities
pursuant to the Securities Act of 1933 (15 U.S.C. 77a et seq.). Form S-
3 provides investors with material information to make investment
decisions regarding securities offered to the public. Form S-3 takes
approximately 467.4195 hours per response and is filed by approximately
1,647 issuers annually. We estimate that 25% of the 647.4195 hours per
response (116.8548 hours) is prepared by the issuer for a total annual
reporting burden of 192,460 hours (116.8548 hours per response x 1,647
responses).
    An agency may conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or by
sending an email to<EMAIL_ADDRESS>
    Dated: August 4, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-16906 Filed 8-6-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 61 (Monday, March 30, 2020)]
[Notices]
[Pages 17611-17613]
[FR Doc No: 2020-06518]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-33824/March 25, 2020]

Order Under Section 6(C) and Section 38(A) of the Investment
Company Act of 1940 Granting Exemptions From Specified Provisions of
the Investment Company Act and Certain Rules Thereunder; Commission
Statement Regarding Prospectus Delivery

    On March 13, 2020, in response to the potential effects of
coronavirus disease 2019 (COVID-19), the Securities and Exchange
Commission (the ``Commission'') issued an order \1\ (the ``Original
Order'') pursuant to its authority under Sections 6(c) and 38(a) of the
Investment Company Act of 1940 (the ``Investment Company Act'' or
``Act'') granting exemptions from certain provisions of that Act and
the rules thereunder. The Commission has been monitoring the effects of
COVID-19 and is now extending the exemptions with certain modifications
in light of its current understanding of the circumstances. The health
and safety of all participants in the securities markets is of
paramount importance, and the Commission recognizes that investment
companies and other market participants continue to face challenges in
meeting the requirements of the federal securities laws addressed in
the Original Order in a timely manner. For this reason and the reasons
stated in the Original Order, the Commission finds that extending the
exemptions, pursuant to its authority under Sections 6(c) and 38(a) of
the Investment Company Act, is necessary and appropriate in the public
interest and consistent with the protection of investors and the
purposes fairly intended by the policy and provisions of the Investment
Company Act, and necessary and appropriate to the exercise of the
powers conferred on it by the Investment Company Act. The necessity for
prompt action of the Commission does not permit prior notice of the
Commission's action. This Order supersedes the Original Order.
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    \1\ Investment Company Act Release No. 33817 (Mar. 13, 2020),
available at https://www.sec.gov/rules/other/2020/ic-33817.pdf.
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    As explained in the Original Order, the Commission has heard from
industry representatives that COVID-19 is presenting challenges for
boards of directors of registered management investment companies and
business development companies (``BDCs'') to travel in order to meet
the in-person voting requirements under the Investment Company Act and
rules thereunder. In addition, we recognize that registered management
investment companies and unit investment trusts (together, ``registered
funds'') may face challenges if, as a result of COVID-19, personnel of
registered fund managers or other third-party service providers that
are necessary to prepare these reports become unavailable, or only
available on a limited basis, in: (i) Preparing or transmitting annual
and semi-annual shareholder reports; and/or (ii) timely filing Forms N-
CEN and N-PORT. We also understand that due to recent market movements
certain registered closed-end funds (``closed-end funds'') and BDCs may
seek to call or redeem securities and may face challenges in providing
the advance notice required under Rule 23c-2. Finally, we appreciate
that there may be difficulties in the timely delivery of registered
fund prospectuses. In light of the current situation, we are issuing
this Order, which provides the same exemptions from requirements of the
Investment Company Act and reiterates our statement regarding
prospectus delivery obligations of registered funds but extends the
period for which this position is available and updates the associated
notice requirements.

I. Time Period for the Exemptive Relief

    The time period for the relief specified in this Order is as
follows:
     For the relief in Sections II and V of this Order, the
relief is limited to the period from (and including) the date of the
Original Order to (and including) August 15, 2020.
     For the relief in Sections III and IV of this Order, the
relief is limited to filing or transmittal obligations, as applicable,
for which the original due

date is on or after the date of the Original Order but on or prior to
June 30, 2020.
    The Commission intends to continue to monitor the current
situation. The time period for any or all of the relief may, if
necessary, be extended with any additional conditions that are deemed
appropriate, and the Commission may issue other relief as necessary or
appropriate.

II. In-Person Board Meeting Requirements for Registered Management
Investment Companies and BDCs

    It is ordered, pursuant to Sections 6(c) and 38(a) of the Act:
    That for the period specified in Section I, a registered management
investment company or BDC and any investment adviser of or principal
underwriter for such registered management investment company or BDC is
exempt from the requirements imposed under sections 15(c) and 32(a) of
the Investment Company Act and Rules 12b-1(b)(2) and 15a-4(b)(2)(ii)
under the Investment Company Act that votes of the board of directors
of either the registered management investment company or BDC be cast
in person, provided that:
    (i) Reliance on this Order is necessary or appropriate due to
circumstances related to current or potential effects of COVID-19;
    (ii) the votes required to be cast at an in-person meeting are
instead cast at a meeting in which directors may participate by any
means of communication that allows all directors participating to hear
each other simultaneously during the meeting; and
    (iii) the board of directors, including a majority of the directors
who are not interested persons of the registered management investment
company or BDC, ratifies the action taken pursuant to this exemption by
vote cast at the next in-person meeting.

III. Forms N-CEN and N-Port Filing Requirements

    In light of our current understanding of the nationwide scope of
COVID-19's disruptions to businesses and everyday activities, and the
uncertainty as to the duration of these disruptions, we are removing
the Original Order's conditions that a registered fund that intends to
rely upon the relief must (i) include, in its email correspondence to
Commission staff and on its website, a brief description of the reasons
why it is unable to file Form N-CEN or Form N-PORT and (ii) provide
Commission staff with an estimated date by which it expects to file
such report.
    Accordingly, it is ordered, pursuant to Section 6(c) and 38(a) of
the Investment Company Act:
    That for the period specified in Section I, a registered fund that
is required to file Form N-CEN pursuant to Rule 30a-1 under the
Investment Company Act, or Form N-PORT pursuant to Rule 30b1-9 under
the Investment Company Act, is temporarily exempt from such form filing
requirements where the conditions below are satisfied.

Conditions

    (a) The registered fund is unable to meet a filing deadline due to
circumstances related to current or potential effects of COVID-19;
    (b) Any registered fund relying on this Order promptly notifies the
Commission staff via email at<EMAIL_ADDRESS>stating that
it is relying on this Order;
    (c) Any registered fund relying on this Order includes a statement
on the applicable registered fund's public website briefly stating that
it is relying on this Order;
    (d) The registered fund required to file such Form N-CEN or Form N-
PORT files such report as soon as practicable, but not later than 45
days after the original due date; and
    (e) Any Form N-CEN or Form N-PORT filed pursuant to this Order must
include a statement of the filer that it relied on this Order and the
reasons why it was unable to file such report on a timely basis.

IV. Transmittal of Annual and Semi-Annual Reports to Investors Required
by the Investment Company Act and the Rules Thereunder

    In light of our current understanding of the nationwide scope of
COVID-19's disruptions to businesses and everyday activities, and the
uncertainty as to the duration of these disruptions, we are removing
the Original Order's conditions that a registered fund that intends to
rely upon the relief must (i) include, in its email correspondence to
Commission staff and on its website, a brief description of the reasons
why it is unable to file its report on a timely basis, and (ii) provide
the Commission staff with an estimated date by which it expects to file
such report.
    Accordingly, it is ordered, pursuant to Sections 6(c) and 38(a) of
the Investment Company Act:
    That for the period specified in Section I, a registered management
investment company is temporarily exempt from the requirements of
Section 30(e) of the Investment Company Act and Rule 30e-1 thereunder
to transmit annual and semi-annual reports to investors where the
conditions below are satisfied; and
    For the period specified in Section I, a registered unit investment
trust is temporarily exempt from the requirements of Section 30(e) of
the Investment Company Act and Rule 30e-2 thereunder to transmit annual
and semi-annual reports to unitholders where the conditions below are
satisfied.

Conditions

    (a) The registered fund is unable to prepare or transmit the report
due to circumstances related to current or potential effects of COVID-
19;
    (b) Any registered fund relying on this Order promptly notifies
Commission staff via email at<EMAIL_ADDRESS>stating that
it is relying on this Order;
    (c) Any registered fund relying on this Order includes a statement
on the applicable registered fund's public website briefly stating that
it is relying on this Order; and
    (d) The registered fund transmits the reports to shareholders as
soon as practicable, but not later than 45 days after the original due
date and files the report within 10 days of its transmission to
shareholders.

V. Timing of Filing Form N-23C-2 With the Commission Required by the
Investment Company Act and the Rules Thereunder

    In light of our current understanding of the nationwide scope of
COVID-19's disruptions to businesses and everyday activities, and the
uncertainty as to the duration of these disruptions, we are removing
the Original Order's conditions that a closed-end fund or BDC that
intends to rely upon the relief must include, in its email
correspondence to Commission staff, a brief description of the reasons
why it needs to file a Notice fewer than 30 days in advance of the date
set by the closed-end fund or BDC, as applicable, for calling or
redeeming the securities of which it is the issuer.
    Accordingly, it is ordered, pursuant to Section 6(c) and 38(a) of
the Investment Company Act:
    That for the period specified in Section I, closed-end funds and
BDCs are temporarily exempt from the requirement to file with the
Commission notices of their intention to call or redeem securities at
least 30 days in advance under Sections 23(c) and 63, as applicable, of
the
    Investment Company Act and Rule 23c-2 thereunder if such company
files a Form N-23C-2 (``Notice'') with the

Commission fewer than 30 days prior to, including the same business day
as, the company's call or redemption of securities of which it is the
issuer where the conditions below are satisfied:

Conditions

    (a) The closed-end fund or BDC (``Company'') relying on this Order:
    (1) Promptly notifies Commission staff via email at<EMAIL_ADDRESS>stating that it is relying on this Order;
    (2) ensures that the filing of the Notice on an abbreviated time
frame is permitted under relevant state law and the Company's governing
documents; and
    (3) files a Notice that contains all the information required by
Rule 23c-2 prior to:
    a. Any call or redemption of existing securities;
    b. the commencement of any offering of replacement securities; and
    c. providing notification to the existing shareholders whose
securities are being called or redeemed.

VI. Commission Statement Regarding Prospectus Delivery

    The Commission takes the position that it would not provide a basis
for a Commission enforcement action if a registered fund does not
deliver to investors the current prospectus of the registered fund
where the prospectus is not able to be timely delivered because of
circumstances related to COVID-19 and delivery was due during the
limited period specified below, provided that the sale of shares to the
investor was not an initial purchase by the investor of shares of the
registered fund and:
    (1) The registered fund:
    (a) Notifies Commission staff via email at<EMAIL_ADDRESS>stating that it is relying on this Commission
position;
    (b) Publishes on its public website that it intends to rely on the
Commission position; and
    (c) Publishes its current prospectus on its public website; and
    (2) Delivery was originally required on or after the date of this
Order but on or prior to June 30, 2020, and the prospectus is delivered
to investors as soon as practicable, but not later than 45 days after
the date originally required.
    In light of our current understanding of the nationwide scope of
COVID-19's disruptions to businesses and everyday activities, and the
uncertainty as to the duration of these disruptions, we are modifying
our previous position that a registered fund that intends to rely upon
this relief must (i) include, in its email correspondence to Commission
staff and on its website, a brief description of the reasons why it or
any other person required could not deliver the prospectus to investors
on a timely basis, and (ii) provide the Commission staff with an
estimated date by which it expects the prospectus to be delivered.

    By the Commission.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-06518 Filed 3-27-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2792-2794]
[FR Doc No: 2018-00917]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1309]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Compounded Drug Products That Are Essentially Copies of a
Commercially Available Drug Product Under Section 503A of the Federal
Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
February 20, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910--NEW and
title ``Guidance for Industry on Compounded Drug Products that are
Essentially Copies of a Commercially Available Drug Product Under
Section 503A of the Federal Food, Drug, and Cosmetic Act.'' Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry on Compounded Drug Products That Are Essentially
Copies of a Commercially Available Drug Product Under Section 503A of
the Federal Food, Drug, and Cosmetic Act

OMB Control Number 0910--NEW

    This information collection supports the above captioned Agency
guidance document. In the Federal Register of July 11, 2016 (81 FR
44881), FDA announced the availability of a draft guidance for industry
entitled ``Guidance for Industry on Compounded Drug Products That Are
Essentially Copies of a Commercially Available Drug Product Under
Section 503A of the Federal Food, Drug, and Cosmetic Act,'' and
included an analysis of the associated information collection.
    Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 353a) describes conditions that must be met in order for
compounded drugs to receive exemptions from certain sections of the
FD&C Act, including section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B))
(concerning current good manufacturing practice for drugs); section
502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with

adequate directions for use) and section 505 (21 U.S.C. 355)
(concerning the approval of human drug products under new drug
applications or abbreviated new drug applications).
    One condition of section 503A is that a compounder ``does not
compound regularly or in inordinate amounts (as defined by the
Secretary) any drug products that are essentially copies of a
commercially available drug product'' (section 503A(b)(1)(D)). However,
for the purposes of this section, ``essentially a copy of a
commercially available drug product'' does not include a drug product
``in which there is a change, made for an identified individual
patient, which produces for that patient a significant difference, as
determined by the prescribing practitioner, between the compounded drug
and the comparable commercially available drug product'' (section
503A(b)(2)).
    The draft guidance states that if a compounder intends to rely on
such a determination to establish that a compounded drug is not
essentially a copy of a commercially available drug product, the
compounder should ensure that the determination is documented on a
prescription. If a prescription does not make clear that the prescriber
made the determination required by section 503A(b)(2), or a compounded
drug is substituted for the commercially available product at the
pharmacy, the compounder may contact the prescriber and if the
prescriber confirms it, make a notation on the prescription that the
compounded product contains a change that makes a significant
difference for the patient. The notations should be as specific as
those described in this document, and the date of the conversation with
the prescriber should be included on the prescription.
    In addition, if the drug was compounded because the approved
product was not commercially available because it was on the FDA drug
shortage list, the prescription or a notation on the prescription
should note that it was on the drug shortage list and the date the list
was checked.
    Finally, compounders under section 503A should maintain records of
the frequency in which they have compounded drug products that are
essentially copies of commercially available drug products and the
number of prescriptions that they have filled for compounded drug
products that are essentially copies of commercially available drug
products to document that such compounding has not been done
``regularly'' or in ``inordinate amounts.''
    FDA received 88 comments on the draft guidance, several of which
raised issues pertaining to the information collection provisions in
the draft guidance. The issues raised are addressed below.
    Issue One: One commenter proposed that any compounded drug with the
same Active Pharmaceutical Ingredient (API) as a commercially available
drug product should be considered to be ``essentially a copy'' of the
commercially available drug product.
    FDA Response to Issue One: FDA has not made this proposed change. A
compounded drug with the same API as a commercially available drug
product may be very different from that commercially available drug
product. For example, it may have a different route of administration
and a substantially different strength. In such cases, a prescriber
determination is not needed because the compounded drug would not be
considered to be ``essentially a copy'' of the commercially available
drug product, even if it had the same API.
    Issue Two: Several individuals submitted comments requesting the
collection of additional information than what was proposed in the
draft guidance.
     One commenter requested that the medical record maintained
by the prescriber should include additional scientific rationale for
prescribing the compounded product.
     Another commenter requested documentation to justify the
use of a bulk drug substance to compound a product that could have been
made starting with FDA-approved products.
    FDA Response to Issue Two: Regarding the first comment, this
recommendation regarding what information a prescriber should maintain
is outside the scope of this guidance. Regarding the second comment,
the proposal is beyond the scope of the current guidance and we express
no opinion on the proposed analysis and documentation.
    Issue Three: Several individuals submitted comments regarding
collection of the prescriber determination in the hospital setting.
     Some commenters noted the prescriber determination is not
necessary in the hospital setting because pharmacists often determine
when a compounded drug is needed for a patient and not the prescriber.
For example, one commenter noted that hospitals may have standing
policies that specify use of compounded drugs in certain scenarios.
     Other commenters suggested use of a template or
``blanket'' prescriber determination statement when certain drugs are
needed for a patient population on a consistent basis.
     Another commenter noted that State scope of practice acts
or hospital policy may prohibit pharmacists from writing in the patient
chart or altering the electronic health record.
    FDA Response to Issue Three: FDA is considering the applicability
of the policies described in this guidance to hospitals and health
systems and intends to address these issues in separate guidance.
    Issue Four: Several individuals commented that it would be
burdensome to document the prescriber determination, as well as to call
a prescriber to document a prescriber determination when such
determination is not evident on the original prescription. Individuals
felt a prescriber determination should not be necessary in certain
cases, such as when a prescription indicates a compounded drug.
    FDA Response to Issue Four: Section 503A(b)(2) provides that a
compounded drug is not essentially a copy of a commercially available
drug product if there is a change, made for an identified individual
patient, which produces for that patient a significant difference, as
determined by the prescribing practitioner, between the compounded drug
and the comparable commercially available drug. If a prescription
already documents the prescriber's determination of significant
difference, there is no additional documentation burden for the
compounder. However, if a prescription does not make clear that the
prescriber made the determination required by section 503A(d)(2), or a
compounded drug is substituted for the commercially available product
at the pharmacy, the compounder may contact the prescriber, and if the
prescriber confirms it, make a notation on the prescription that the
compounded product contains a change that makes a significant
difference for the patient. FDA estimates this contact will take 3
minutes and should not present significant burden. Maintaining
prescription records that may include such notations should not present
any additional burden, as FDA understands that maintaining records of
prescriptions for compounded drug products is part of the usual course
of the practice of compounding and selling drugs and is required by
States' pharmacy laws and other State laws governing recordkeeping by
health care professionals and health care facilities. Finally, FDA
notes that calling a prescriber to document a prescriber determination
of significant difference is not a requirement. For example, the

compounder has the option of not filling a prescription with a
compounded drug if a prescriber determination is not provided.
    Issue Five: One commenter stated that requiring a notation on the
prescription that a compounded drug was on the drug shortage list when
compounded, and the date the list was checked, would be overly
burdensome.
    FDA Response to Issue Five: FDA does not believe this presents a
significant burden, as a compounder that wants to rely on a drug
shortage to establish that a compounded drug is not essentially a copy
of a commercially available drug would need to check FDA's shortage
website. Noting the date the list was checked is not onerous, and is
necessary for FDA to verify compliance during inspections. FDA
estimates this activity would take 2 minutes.
    Issue Six: One commenter requested clarity on how long records
should be maintained; what specific information should be maintained;
and when such records should be presented to FDA.
    FDA Response to Issue Six: FDA has revised the guidance to include
a recommended duration of 3 years for maintaining records. The guidance
describes the records that can be retained to demonstrate compliance.
FDA may request to review such records during establishment
inspections.
    FDA estimates the burden of this collection of information as
follows:
    We estimate that annually a total of approximately 6,888
compounders (``number of respondents'' in table 1, line 1) will consult
a prescriber to determine whether he or she has made a determination
that the compounded drug has a change that produces a significant
difference for a patient as compared to the comparable commercially
available drug, and that the compounders will document this
determination on approximately 172,200 prescription orders for
compounded drugs (``total annual disclosures'' in table 1, line 1). We
estimate that the consultation between the compounder and the
prescriber and adding a notation to each prescription that does not
already document this determination will take approximately 3 minutes
per prescription order.
    In addition, we estimate that a total of approximately 6,888
compounders (``number of respondents'' in table 1, line 2) will
document this information on approximately 344,400 prescription orders
for compounded drugs (``total annual disclosures'' in table 1, line 2).
We estimate that checking FDA's drug shortage list and documenting this
information will take approximately 2 minutes per prescription order.
    We estimate that a total of approximately 3,444 compounders
(``number of recordkeepers'' in table 2) will keep approximately
165,312 records (``total annual records''). We estimate that
maintaining the records will take approximately 2 minutes per record.

                                               Table 1--Estimated Annual Third Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
              Type of reporting                  Number of      disclosures    Total annual          Average burden per disclosure          Total hours
                                                respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consultation between the compounder and                6,888              50         344,400  0.05 (3 minutes)..........................          17,220
 prescriber and the notation on the
 prescription documenting the prescriber's
 determination of significant difference.
Checking FDA's drug shortage list and                  6,888              50         344,400  0.03 (2 minutes)..........................          10,332
 documenting on the prescription that the
 drug is in shortage.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          27,552
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
            Type of recordkeeping                Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records of frequency and number of                     3,444              48         165,312  0.03 (2 minutes)..........................           4,959
 prescriptions filled for compounded drugs
 that are essentially a copy.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: January 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00917 Filed 1-18-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Pages 61404-61405]
[FR Doc No: 2015-25914]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC15-169-000.
    Applicants: MDU Resources Group, Inc., Thunder Spirit Wind, LLC,
Ace Wind LLC.
    Description: Supplement to July 14, 2015 Application of MDU
Resources Group, Inc., et al. for Authorization Under Section 203 of
the Federal Power Act for Disposition of Jurisdiction Facilities.
    Filed Date: 10/6/15.
    Accession Number: 20151006-5160.
    Comments Due: 5 p.m. ET 10/16/15.

    Docket Numbers: EC16-1-000.
    Applicants: Emera Incorporated, TECO Energy, Inc.
    Description: Application under FPA Section 203 of Emera
Incorporated and TECO Energy, Inc.
    Filed Date: 10/5/15.
    Accession Number: 20151005-5344.
    Comments Due: 5 p.m. ET 10/26/15.

    Docket Numbers: EC16-2-000.
    Applicants: AltaGas Power Holdings (U.S.) Inc., GWF Energy LLC.
    Description: Joint Application for Authorization under Section 203
of the Federal Power Act, Request for Expedited Consideration and
Confidential Treatment of GWF Energy LLC and AltaGas Power Holdings
(U.S.) Inc.
    Filed Date: 10/5/15.
    Accession Number: 20151005-5350.
    Comments Due: 5 p.m. ET 10/26/15.

    Docket Numbers: EC16-3-000.
    Applicants: Goodwell Wind Project, LLC.
    Description: Application for Authorization under Section 203 of the
Federal Power Act, Request for Expedited Consideration and Confidential
Treatment of Goodwell Wind Project, LLC.
    Filed Date: 10/6/15.
    Accession Number: 20151006-5235.
    Comments Due: 5 p.m. ET 10/27/15.

    Docket Numbers: EC16-4-000.
    Applicants: Eden Solar LLC, Land of the Sky MT, LLC.
    Description: Application for Authorization under Section 203 of the
Federal Power Act, Request for Expedited Consideration and Confidential
Treatment of Eden Solar, LLC and Land of the Sky MT, LLC.
    Filed Date: 10/6/15.
    Accession Number: 20151006-5280.
    Comments Due: 5 p.m. ET 10/27/15.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG16-4-000.
    Applicants: Greenidge Generation LLC.
    Description: Self-Certification of EG or FC of Greenidge Generation
LLC.
    Filed Date: 10/6/15.
    Accession Number: 20151006-5290.
    Comments Due: 5 p.m. ET 10/27/15.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2074-005; ER10-2097-007.
    Applicants: Kansas City Power & Light Company, KCP&L Greater
Missouri Operations Company.
    Description: Supplement to June 30, 2015 Updated Market Power
Analysis for Southwest Power Pool, Inc. Balancing Area Authority of
Kansas City Power & Light Company, et al.
    Filed Date: 10/6/15.
    Accession Number: 20151006-5217.
    Comments Due: 5 p.m. ET 10/27/15.

    Docket Numbers: ER15-2114-001.
    Applicants: PJM Interconnection, L.L.C., Transource West Virginia,
LLC.
    Description: Compliance filing: Transource submits a compliance
filing on Attachment H-26 & 26A per 9/4/15 Order to be effective 9/5/
2015.
    Filed Date: 10/5/15.
    Accession Number: 20151005-5295.
    Comments Due: 5 p.m. ET 10/26/15.

    Docket Numbers: ER16-26-000.
    Applicants: Tucson Electric Power Company.
    Description: Section 205(d) Rate Filing: Rate Schedule
Cancellations to be effective 12/7/2015.
    Filed Date: 10/6/15.
    Accession Number: 20151006-5211.
    Comments Due: 5 p.m. ET 10/27/15.

    Docket Numbers: ER16-27-000.
    Applicants: Northern States Power Company, a Minnesota corporation.
    Description: Section 205(d) Rate Filing: 2015-10-6 NSP-GFLS-TSA-
436-0.0.0-Filing to be effective 1/1/2015.
    Filed Date: 10/6/15.
    Accession Number: 20151006-5220.
    Comments Due: 5 p.m. ET 10/27/15.

    Docket Numbers: ER16-28-000.
    Applicants: PacifiCorp.
    Description: Notice of Termination of Los Angeles Department of
Water and Power Power Purchase Agreement Rate Schedule 301 of
PacifiCorp.
    Filed Date: 10/6/15.
    Accession Number: 20151006-5272.
    Comments Due: 5 p.m. ET 10/27/15.

    Docket Numbers: ER16-29-000.
    Applicants: Greenidge Generation LLC.
    Description: Baseline eTariff Filing: Application for MBR to be
effective 12/7/2015.
    Filed Date: 10/6/15.
    Accession Number: 20151006-5275.
    Comments Due: 5 p.m. ET 10/27/15.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES15-68-000.
    Applicants: Kentucky Utilities Company.
    Description: Revised Exhibits C, D, and E to September 4, 2015
Application under Section 204 of the Federal Power Act of Kentucky
Utilities Company.
    Filed Date: 10/6/15.
    Accession Number: 20151006-5238.

    Comments Due: 5 p.m. ET 10/27/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 6, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-25914 Filed 10-9-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53275-53276]
[FR Doc No: 2018-22959]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4308]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance for
Industry: Labeling of Red Blood Cell Units With Historical Antigen
Typing Results

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, or Agency) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
November 21, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-NEW and
title ``Draft Guidance for Industry: Labeling of Red Blood Cell Units
with Historical Antigen Typing Results.'' Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Labeling of Red Blood Cell Units With Historical Antigen Typing
Results, OMB Control Number 0910-NEW

    The draft guidance document provides establishments that collect
blood and blood components for transfusion with recommendations for
labeling RBC units with non-ABO/Rh(D) antigen typing results obtained
from previous donations (historical antigen typing results). The draft
guidance provides recommendations to transfusion services for managing
RBC units labeled with historical antigen typing results. The guidance
also provides licensed blood collection establishments that choose to
implement labeling of RBC units with historical antigen typing results
instructions regarding how to report the manufacturing and labeling
changes under 21 CFR 601.12.
    Description of Respondents: Establishments that collect blood and
blood components intended for transfusion.
    Burden Estimate: We believe that the information collection
provisions in the draft guidance do not create a new burden for
respondents and are part of usual and customary business practices.
According to the 30th edition of the AABB Standards for Blood Banks and
Transfusion Services, RBC units may be labeled as RBC antigen negative
without testing the current donation if two previous separate donations
were tested by the collection facility and results of RBC typing were
found to be concordant. The standards indicate that facilities have the
option to put the non-ABO/Rh(D) historical antigen typing results on a
tie-tag or directly on the container label.
    The guidance also recommends establishments that collect blood and
blood components for transfusion should convey to transfusion services
the practices for repeating historical RBC typing results on current
donations and for labeling RBC units with historical RBC antigen typing
results.
    We believe that collection establishments have already developed
standard operating procedures for including the non-ABO/Rh(D)
historical antigen typing results on a tie-tag or directly on the
container label, and for conveying any change in their antigen typing
or labeling practices to their consignees, including practices for
repeating historical RBC typing results on current donations and for
labeling RBC units with historical RBC antigen typing results.
    In the Federal Register of January 3, 2017 (82 FR 130), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received six comments on the guidance;
however, no comments were related to the collection of information.
    The draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR 601.12 have been approved under OMB control number 0910-0338;
and the collections of information in 21 CFR

part 606 have been approved under OMB control number 0910-116.

    Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22959 Filed 10-19-18; 8:45 am]
 BILLING CODE 4164-01-P