[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Rules and Regulations]
[Pages 30716-30721]
[FR Doc No: 2014-12458]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 16

[Docket No. FDA-2013-N-0365]

Administrative Detention of Drugs Intended for Human or Animal
Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
implementing administrative detention authority with respect to drugs
intended for human or animal use as authorized by amendments made to
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Food and
Drug Administration Safety and Innovation Act (FDASIA). FDA's
administrative detention authority with respect to drugs allows FDA to
better protect the integrity of the drug supply chain. Specifically,
FDA is able to administratively detain drugs encountered during an
inspection that an authorized FDA representative conducting an
inspection has reason to believe are adulterated or misbranded. This
authority is intended to protect the public by preventing distribution
or subsequent use of drugs encountered during inspections that are
believed to be adulterated or misbranded, until FDA has had time to
consider what action it should take concerning the drugs, and to
initiate legal action, if appropriate.

DATES: This rule is effective June 30, 2014.

FOR FURTHER INFORMATION CONTACT: Charlotte Hinkle, Office of Regulatory
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 4343, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Regulatory Action

    FDA's administrative detention authority with respect to drugs
intended for human or animal use allows FDA to better protect the
integrity of the drug supply chain. Specifically, administrative
detention is intended to protect the public by preventing distribution
or subsequent use of drugs encountered during inspections that may be
adulterated or misbranded, until FDA has had time to consider what
action it should take concerning the drugs, and to initiate legal
action, if appropriate. FDA already has the authority to
administratively detain devices, tobacco, and foods that FDA has reason
to believe are adulterated or misbranded.
    FDA is issuing this final rule under section 304(g) of the FD&C Act
(21 U.S.C. 334(g)), as amended by section 709 of FDASIA, and section
701 of the FD&C Act (21 U.S.C. 371). Section 304(g) of the FD&C Act
also authorizes FDA to administratively detain devices and tobacco
products.

Summary of the Major Provisions

    This final rule implements a regulation for the administrative
detention of drugs. FDA is amending parts 1 and 16 (21 CFR parts 1 and
16) to create an implementing rule for this authority. The changes set
forth the procedures for detention of drugs believed to be adulterated
or misbranded and amend the scope of FDA's part 16 regulatory hearing
procedures to include the administrative detention of drugs.

Costs and Benefits

    The primary public health benefits from adoption of the final rule
would be the value of the illnesses or deaths prevented because the
Agency administratively detained a drug it has reason to believe is
adulterated or misbranded; this benefit occurs only if the drug would
not have been prevented from entering the market using one of the
Agency's other enforcement tools. The estimated primary costs to FDA
include marking or labeling the detained product and costs associated
with appeals of detention orders. The Agency estimates the net annual
social costs to be between $0 and $602,602.

I. Background

    In the Federal Register of July 15, 2013 (78 FR 42381), FDA
proposed regulations to implement its new authority to administratively
detain drugs that an authorized FDA representative conducting an
inspection under section 704 of the FD&C Act (21 U.S.C. 374) has reason
to believe are adulterated or misbranded. As discussed in the preamble
to the proposed rule, on July 9, 2012, President Obama signed into law
FDASIA (Public Law 112-144). Title VII of FDASIA provides FDA with
important new authorities to help it better protect the integrity of
the drug supply chain. One of those new authorities is section 709,
which amends section 304(g) of the FD&C Act to provide FDA with
administrative detention authority with respect to drugs. Section
304(g) of the FD&C Act, as amended by FDASIA, provides FDA the same
authority to detain drugs that section 304(g) already provides FDA with
respect to devices and tobacco products. Once these implementing
regulations with respect to drugs take effect, the amendments to
section 304(g) of the FD&C Act will allow FDA to administratively
detain drugs that an authorized FDA representative conducting an
inspection under section 704 of the FD&C Act has reason to believe are
adulterated or misbranded, until FDA has had time to consider what
action it should take concerning the drugs, and to initiate legal
action, if appropriate.

II. Overview of the Final Rule Including Changes to the Proposed Rule

A. Revisions to Part 1

    FDA is amending title 21 of the Code of Federal Regulations, part 1
to create an implementing regulation for the administrative detention
of drugs. The amendment to part 1 consists of one section, Sec.  1.980,
under a new subpart, which is titled ``Subpart Q--Administrative
Detention of Drugs Intended for Human or Animal Use.'' Section 1.980
sets forth the procedures for the administrative detention of drugs
encountered during an inspection that are believed to be adulterated or
misbranded. The new regulation is closely modeled on the current
regulation for the administrative detention of devices (21 CFR 800.55).
There are minor differences from the device regulation, including
updates to statutory references to refer to drugs instead of devices
and changes to language to conform to current Federal Register
requirements. Since FDA issued the proposed rule on administrative
detention of drugs, FDA has issued other regulations in part 1,
requiring reassignment of the section number within part 1. No other
changes have been made to the substance of the proposed regulation.
Other than renumbering the section, FDA is finalizing the implementing
regulations as proposed.

B. Revisions to Part 16

    The amendment to part 16 is a technical change. This change amends
a statement in Sec.  16.1 so that the scope of part 16 regulatory
hearing procedures also will include administrative

detention authority with respect to drugs.

III. Comments on the Proposed Rule

    FDA received six comments in the docket for the July 15, 2013,
proposed rule on administrative detention of drugs, three of which were
responsive. However, after considering these comments, the Agency is
not making any changes to the regulatory language included in the
proposed rule. Relevant portions of the responsive comments are
summarized and responded to in this document. The Agency did not
consider nonresponsive comments in developing this final rule. To make
it easier to identify comments and our responses, the word ``Comment,''
in parentheses, appears before the comment's description, and the word
``Response,'' in parentheses, appears before our response. We have
numbered each comment and response to help distinguish between
different comments. Similar comments are grouped together under the
same number. The number assigned to each comment is purely for
organization purposes and does not signify the comment's value or
importance or the order in which it was received. Comments addressing
the proposed implementing regulation for the administrative detention
of drugs and FDA's responses follow.

A. Standard for Administrative Detention Order

    In the proposed rule, FDA proposed that an administrative detention
of drugs may be ordered when an authorized FDA representative, during
an inspection under section 704 of the FD&C Act, has reason to believe
that a drug is adulterated or misbranded. Two comments suggested the
Agency modify the proposed standard for issuing an administrative
detention order.
    (Comment 1) One commenter stated that the term ``adulteration'' is
very broad and suggested that, to ensure that patients continue to have
access to safe medications, the Agency should add an element of
potential risk of public harm to the detention standard.
    (Response 1) The Agency does not have the authority to change the
administrative detention standard, which is specified by statute.
Section 304(g) of the FD&C Act provides, in relevant part: ``If during
an inspection conducted under section 704 of a facility or vehicle, a
drug which the officer or employee making the inspection has reason to
believe is adulterated or misbranded is found in such facility or
vehicle, such officer may order the drug detained (in accordance with
regulations prescribed by the Secretary).'' Furthermore, we note that
the terms ``adulterated'' and ``misbranded'' are well characterized by
both the adulteration and misbranding provisions of the FD&C Act, its
implementing regulations, and a substantial body of case law. For
example, sections 501 and 502 of the FD&C Act (21 U.S.C. 351 and 352)
provide criteria for determining whether a drug will be considered to
be adulterated or misbranded, respectively. Because these terms are
already well characterized, we do not believe it necessary or
appropriate to further define or modify the meaning of these terms for
the purposes of this rule.
    (Comment 2) One commenter suggested that the Agency should
administratively detain shipments based on a pre-determined, justified
level of suspicion, with an example that the Agency may wish to
scrutinize more closely shipments that are not from a known shipper or
known consignor.
    (Response 2) The commenter's reference to ``shipper and
``consignor'' indicate that the commenter is confusing administrative
detention of a drug during an inspection under section 304(g) of the
FD&C Act with the process of reviewing imported products under section
801(a) of the FD&C Act (21 U.S.C. 381). Under Sec.  1.94, when it
appears to FDA that an imported article may be subject to refusal of
admission under section 801(a) of the FD&C Act, FDA provides a notice
of that fact to the owner or consignee and provides them with an
opportunity to introduce testimony. This notice is commonly called a
``Notice of Detention and Hearing'' (see, e.g., FDA Regulatory
Procedures Manual, chapter 9, pp. 9-29) (Ref. 1) and is not related to
administrative detention under section 304(g) of the FD&C Act.

B. Notification of Detention Order

    In the proposed rule, FDA proposed that the detention order be
issued in writing, in the form of a detention notice, signed by the
authorized FDA representative who has reason to believe that the drugs
are adulterated or misbranded, and issued to the owner, operator, or
agent in charge of the place where the drugs are located. If the owner
or the user of the drugs is different from the owner, operator, or
agent in charge of the place where the drugs are detained, a copy of
the detention order must be provided to the owner or user of the drugs
if the owner's or user's identity can be readily determined. If
detention of drugs in a vehicle or other carrier is ordered, a copy of
the detention order must be provided to the shipper of record and the
owner of the vehicle or other carrier, if their identities can be
readily determined. An FDA representative issuing a detention order
must label or mark the drugs with official FDA tags that include
certain information.
    (Comment 3) One commenter requested that FDA immediately notify the
party responsible (e.g., manufacturer or wholesaler) for the detained
drug to enable drug owners to inform customers that their orders may be
delayed as well as opened and checked by FDA.
    (Response 3) We believe that the notice requirements set forth in
the proposed rule, which we are adopting, together with the requirement
that FDA label or mark the drugs subject to the detention order,
address the commenter's concerns regarding FDA notification of
detention orders to the owner, operator, or agent in charge of the
place where the drugs are located. Furthermore, if the owner or the
user of the drugs is different from the owner, operator, or agent in
charge of the place where the drugs are located, FDA also will provide
a copy of the detention order to the owner or user of the drugs, if
their identity can be readily determined. FDA expects such notification
to be as timely as possible. The procedures FDA puts into place to
implement this rule will address the notice requirements and help
ensure that our investigators are appropriately educated and trained on
the procedural requirements.

C. Appeals of Detention Orders

    In the proposed rule, FDA proposed that the person who would be
entitled to claim the drugs, if seized, may appeal a detention order.
    (Comment 4) Two commenters suggested the Agency clarify that it is
not the intent of the Agency to limit the manufacturer's ability to
appeal a detention order.
    (Response 4) Who may appeal a detention order is determined by
Federal statute. Section 304(g) of the FD&C Act specifies who may
appeal a detention order: ``Any person who would be entitled to claim a
device, drug, or tobacco product if it were seized under [304(a)] may
appeal . . . a detention of such device, drug, or tobacco product. .
.''.
    (Comment 5) One commenter expressed concern that a drug product
subject to a detention order would be withheld from patients without
due process, potentially creating a drug shortage.
    (Response 5) We believe that the detailed notice and appeals
procedures set forth in the proposed rule, which

includes the opportunity for an informal hearing within 5 working days
after the appeal is filed, satisfy the elements of due process. We
appreciate the commenter's concern that an administrative detention
could lead to a drug shortage and note that the Agency has an active
drug shortages program. Preventing drug shortages has been, and
continues to be, a top priority for FDA, and we take great efforts to
address, prevent, and mitigate drug shortages. Yet in making regulatory
and enforcement decisions, FDA not only is concerned with the potential
for drug shortages, but also with the potential for harm to patients
caused by an adulterated or misbranded drug entering into commerce.

D. Movement of Detained Drugs

    In the proposed rule, FDA proposed that, except as provided, no
person may move a detained drug within or from the place where they
were ordered detained until FDA terminates the detention or the
detention period expires, whichever occurs first.
    (Comment 6) Two commenters noted that administrative detention
regulations should provide sufficient flexibility for movement in order
to preserve product integrity during the detention process.
    (Response 6) FDA believes that Sec.  1.980(h)(3)(i) provides the
flexibility sufficient to preserve product quality and integrity during
an administrative detention. Paragraph (h)(3) states that an authorized
FDA representative ``may approve, in writing, the movement of detained
drugs for any of the following purposes: (i) To prevent interference
with an establishment's operation or harm to the drugs.''

E. Notification of Detention Termination

    In the proposed rule, FDA proposed that, if FDA decides to
terminate a detention or when the determination period expires,
whichever occurs first, an FDA representative authorized to terminate a
detention will issue a detention termination notice releasing the drugs
to any person who received the original detention order or that
person's representative and will remove, or authorize in writing the
removal of, the required labels or tags.
    (Comment 7) One commenter suggested adding language that FDA will
notify, by telephone or other means of rapid communication, the person
who received the original detention order or that person's
representative of the detention notification.
    (Response 7) We understand the concern raised by the commenter but
do not believe that the notification of detention requirements should
be revised to require notification by telephone or other means of rapid
communication. As a general matter, current Agency practice with regard
to administrative detentions is to concurrently notify the person who
received the original detention order, or that person's representative,
of the detention termination when a detention termination notice is
sent by mail. We will consider incorporating such notification
processes into Agency procedures to implement administrative detentions
for drugs.

F. Enforcement Concerns

    (Comment 8) One commenter expressed concern regarding the potential
for variability of enforcement among FDA's investigators, particularly
regarding potential adulteration charges under section 501(j) of the
FD&C Act.
    (Response 8) The authorities granted to FDA in Title VII of FDASIA,
including the authority to enforce the prohibition against delaying,
denying, limiting, or refusing an inspection under section 707 of
FDASIA, are a comprehensive package, intended to enhance FDA's
oversight of the global drug supply chain. Implementation of these new
authorities will include measures to help ensure that our investigators
are appropriately educated and trained on the new legal authorities and
implementing procedures.

G. Foreign Inspections

    (Comment 9) One commenter suggested that FDA highlight the intent
and manner in which the Agency intends to collaborate with foreign
governments to apply administrative detention authority abroad.
    (Response 9) We appreciate this comment; however, the focus of this
rule is not on our enforcement implementation, but on the process by
which administrative detention of drugs occurs. If, in the future, we
determine that administrative detention authority with respect to drugs
has a unique application, we will evaluate what guidance or other
information we will need to issue to help ensure transparency.

H. Harmonization With European Union Legislation

    (Comment 10) One commenter suggested that to support global
harmonization, FDA harmonize the administrative detention of drugs to
the highest possible degree with the European Union Falsified Medicines
Directive (EU Directive 2011/62).
    (Response 10) FDA appreciates the comment. We do harmonize with
legislation of our foreign regulatory counterparts to the extent
possible and practicable. In 2011, the European Union (EU) Council
issued the Falsified Medicines Directive in an effort to strengthen the
EU's ability to detect falsified medicines and prevent their entry into
the legitimate supply chain by adding new requirements in four main
areas: Safety features, supply chain and good distribution practices,
active pharmaceutical ingredients, and Internet sales (Ref. 2). This EU
legislation, however, does not address administrative detention of
drugs.

IV. Legal Authority

    FDA is issuing this final rule under sections 304(g) and 701 of the
FD&C Act and section 709 of FDASIA. Section 709 of FDASIA provides FDA
authority to issue regulations regarding administrative detention
authority with respect to drugs. Section 304(g) of the FD&C Act
includes FDA's administrative detention authority with respect to
drugs. The final rule is necessary for efficient enforcement of the
FD&C Act.

V. Analysis of Impacts (Summary of the Regulatory Impact Analysis)

    FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public
Law 104-4). Executive Orders 12866 and 13563 direct Agencies to assess
all costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this final rule would not be an
economically significant regulatory action as defined by Executive
Order 12866.
    If a rule has a significant economic impact on a substantial number
of small businesses, the Regulatory Flexibility Act requires Agencies
to analyze regulatory alternatives that would minimize any significant
impact of a rule on small entities. FDA has determined that this final
rule would not have a significant economic impact on a substantial
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may

result in the expenditure by State, local, and tribal governments, in
the aggregate, or by the private sector, of $100,000,000 or more
(adjusted annually for inflation) in any one year.'' The current
threshold after adjustment for inflation is $141 million, using the
most current (2013) Implicit Price Deflator for the Gross Domestic
Product. FDA does not expect this final rule to result in any 1-year
expenditure that would meet or exceed this amount.
    The primary public health benefits from adoption of the final rule
would be the value of the illnesses or deaths prevented because the
Agency administratively detained a drug it has reason to believe is
adulterated or misbranded; this benefit occurs only if the drug would
not have been prevented from entering the market using one of the
Agency's other enforcement tools. There may also be benefits from
deterrence if administrative detention increases the likelihood that
misbranded or adulterated products will not be marketed in the future.
    The estimated primary costs to FDA include marking or labeling the
detained product and costs associated with appeals of detention orders.
However, other costs, such as loss in market value of a detained drug,
may be incurred if FDA revokes the detention order on appeal. Given the
history of administrative detention use with medical devices and foods,
the likelihood is low of FDA issuing a detention order that is later
revoked on appeal.
    We estimate the annual costs using a range of 0 to 20
administrative detentions performed each year. The Agency estimates the
net annual social costs to be between $0 and $602,602. The present
discounted value over 20 years would be in the range of $0 to
$8,965,196 at a 3 percent discount rate and in the range of $0 to
$6,383,974 at a 7 percent discount rate.
    FDA has examined the economic implications of the final rule as
required by the Regulatory Flexibility Act. If a rule will have a
significant economic impact on a substantial number of small entities,
the Regulatory Flexibility Act requires Agencies to analyze regulatory
options that would lessen the economic effect of the rule on small
entities. We find that this final rule would not have a significant
economic impact on a substantial number of small entities. This
analysis, together with other relevant sections of this document,
serves as the Final Regulatory Flexibility Analysis, as required under
the Regulatory Flexibility Act.
    The full discussion of economic impacts is available in docket FDA-
2013-N-0365 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 3).

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3518(c)(1)(B)(ii)).
Therefore, clearance by the Office of Management and Budget is not
required under the Paperwork Reduction Act of 1995.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects 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. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

VIII. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site address, but FDA is not responsible for any
subsequent changes to the Web site after this document publishes in the
Federal Register.)
    1. FDA Regulatory Procedures Manual, chapter 9, pp. 9-29.
    2. ``Directive 2011/62/EU of the European Parliament and of the
Council of 8 June 2011 amending Directive 2011/83/EC on the Community
code relating to medicinal products for human use, as regards the
prevention of the entry into the legal supply chain of falsified
medicinal products,'' Official Journal of the European Union, January
7, 2011, available at http://ec.europa.eu/health/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf.
    3. Final Regulatory Impact Analysis, Final Regulatory Flexibility
Analysis, and Unfunded Mandates Reform Act Analysis for Administrative
Detention of Drugs Intended for Human or Animal Use, available at
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 16

    Administrative practice and procedure.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR parts 1 and 16 are amended as
follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 is revised to read as
follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c,
350d, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374,
381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.

Subparts L-P--[Added and Reserved]

0
2. Add and reserve subparts L through P.
0
3. Add subpart Q, consisting of Sec.  1.980, to read as follows:

Subpart Q--Administrative Detention of Drugs Intended for Human or
Animal Use

Sec.  1.980  Administrative detention of drugs.

    (a) General. This section sets forth the procedures for detention
of drugs believed to be adulterated or misbranded. Administrative
detention is intended to protect the public by preventing distribution
or use of drugs encountered during inspections that may be adulterated
or misbranded, until the Food and Drug Administration (FDA) has had
time to consider what action it should take concerning the drugs, and
to initiate legal action, if appropriate. Drugs that FDA orders
detained may not be used, moved, altered, or tampered with in any
manner by any person during the detention period, except as authorized
under paragraph (h) of this section, until FDA

terminates the detention order under paragraph (j) of this section, or
the detention period expires, whichever occurs first.
    (b) Criteria for ordering detention. Administrative detention of
drugs may be ordered in accordance with this section when an authorized
FDA representative, during an inspection under section 704 of the
Federal Food, Drug, and Cosmetic Act, has reason to believe that a
drug, as defined in section 201(g) of the Federal Food, Drug, and
Cosmetic Act, is adulterated or misbranded.
    (c) Detention period. The detention is to be for a reasonable
period that may not exceed 20 calendar days after the detention order
is issued, unless the FDA District Director in whose district the drugs
are located determines that a greater period is required to seize the
drugs, to institute injunction proceedings, or to evaluate the need for
legal action, in which case the District Director may authorize
detention for 10 additional calendar days. The additional 10-calendar-
day detention period may be ordered at the time the detention order is
issued or at any time thereafter. The entire detention period may not
exceed 30 calendar days, except when the detention period is extended
under paragraph (g)(6) of this section. An authorized FDA
representative may, in accordance with paragraph (j) of this section,
terminate a detention before the expiration of the detention period.
    (d) Issuance of detention order. (1) The detention order must be
issued in writing, in the form of a detention notice, signed by the
authorized FDA representative who has reason to believe that the drugs
are adulterated or misbranded, and issued to the owner, operator, or
agent in charge of the place where the drugs are located. If the owner
or the user of the drugs is different from the owner, operator, or
agent in charge of the place where the drugs are detained, a copy of
the detention order must be provided to the owner or user of the drugs
if the owner's or user's identity can be readily determined.
    (2) If detention of drugs in a vehicle or other carrier is ordered,
a copy of the detention order must be provided to the shipper of record
and the owner of the vehicle or other carrier, if their identities can
be readily determined.
    (3) The detention order must include the following information:
    (i) A statement that the drugs identified in the order are detained
for the period shown;
    (ii) A brief, general statement of the reasons for the detention;
    (iii) The location of the drugs;
    (iv) A statement that these drugs are not to be used, moved,
altered, or tampered with in any manner during that period, except as
permitted under paragraph (h) of this section, without the written
permission of an authorized FDA representative;
    (v) Identification of the detained drugs;
    (vi) The detention order number;
    (vii) The date and hour of the detention order;
    (viii) The period of the detention;
    (ix) The text of section 304(g) of the Federal Food, Drug, and
Cosmetic Act and paragraphs (g)(1) and (g)(2) of this section;
    (x) A statement that any informal hearing on an appeal of a
detention order must be conducted as a regulatory hearing under part 16
of this chapter, with certain exceptions described in paragraph (g)(3)
of this section; and
    (xi) The location and telephone number of the FDA district office
and the name of the FDA District Director.
    (e) Approval of detention order. A detention order, before
issuance, must be approved by the FDA District Director in whose
district the drugs are located. If prior written approval is not
feasible, prior oral approval must be obtained and confirmed by written
memorandum within FDA as soon as possible.
    (f) Labeling or marking a detained drug. An FDA representative
issuing a detention order under paragraph (d) of this section must
label or mark the drugs with official FDA tags that include the
following information:
    (1) A statement that the drugs are detained by the U.S. Government
in accordance with section 304(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 334(g)).
    (2) A statement that the drugs must not be used, moved, altered, or
tampered with in any manner for the period shown, without the written
permission of an authorized FDA representative, except as authorized in
paragraph (h) of this section.
    (3) A statement that the violation of a detention order or the
removal or alteration of the tag is punishable by fine or imprisonment
or both (section 303 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 333)).
    (4) The detention order number, the date and hour of the detention
order, the detention period, and the name of the FDA representative who
issued the detention order.
    (g) Appeal of a detention order. (1) A person who would be entitled
to claim the drugs, if seized, may appeal a detention order. Any appeal
must be submitted in writing to the FDA District Director in whose
district the drugs are located within 5 working days of receipt of a
detention order. If the appeal includes a request for an informal
hearing, as defined in section 201(x) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(x)), the appellant must request either that
a hearing be held within 5 working days after the appeal is filed or
that the hearing be held at a later date, which must not be later than
20 calendar days after receipt of a detention order.
    (2) The appellant of a detention order must state the ownership or
proprietary interest the appellant has in the detained drugs. If the
detained drugs are located at a place other than an establishment owned
or operated by the appellant, the appellant must include documents
showing that the appellant would have legitimate authority to claim the
drugs if seized.
    (3) Any informal hearing on an appeal of a detention order must be
conducted as a regulatory hearing under regulation in accordance with
part 16 of this chapter, except that:
    (i) The detention order under paragraph (d) of this section, rather
than the notice under Sec.  16.22(a) of this chapter, provides notice
of opportunity for a hearing under this section and is part of the
administrative record of the regulatory hearing under Sec.  16.80(a) of
this chapter;
    (ii) A request for a hearing under this section should be addressed
to the FDA District Director;
    (iii) The last sentence of Sec.  16.24(e) of this chapter, stating
that a hearing may not be required to be held at a time less than 2
working days after receipt of the request for a hearing, does not apply
to a hearing under this section;
    (iv) Paragraph (g)(4) of this section, rather than Sec.  16.42(a)
of this chapter, describes the FDA employees, i.e., regional food and
drug directors, who preside at hearings under this section.
    (4) The presiding officer of a regulatory hearing on an appeal of a
detention order, who also must decide the appeal, must be a regional
food and drug director (i.e., a director of an FDA regional office
listed in part 5, subpart M of this chapter) who is permitted by Sec.
16.42(a) of this chapter to preside over the hearing.
    (5) If the appellant requests a regulatory hearing and requests
that the hearing be held within 5 working days after the appeal is
filed, the presiding officer must, within 5 working days, hold the
hearing and render a decision affirming or revoking the detention.
    (6) If the appellant requests a regulatory hearing and requests
that the hearing be held at a date later than

within 5 working days after the appeal is filed, but not later than 20
calendar days after receipt of a detention order, the presiding officer
must hold the hearing at a date agreed upon by FDA and the appellant.
The presiding officer must decide whether to affirm or revoke the
detention within 5 working days after the conclusion of the hearing.
The detention period extends to the date of the decision even if the 5-
working-day period for making the decision extends beyond the otherwise
applicable 20-calendar-day or 30-calendar-day detention period.
    (7) If the appellant appeals the detention order but does not
request a regulatory hearing, the presiding officer must render a
decision on the appeal, affirming or revoking the detention within 5
working days after the filing of the appeal.
    (8) If the presiding officer affirms a detention order, the drugs
continue to be detained until FDA terminates the detention under
paragraph (j) of this section or the detention period expires,
whichever occurs first.
    (9) If the presiding officer revokes a detention order, FDA must
terminate the detention under paragraph (j) of this section.
    (h) Movement of detained drugs. (1) Except as provided in this
paragraph, no person may move detained drugs within or from the place
where they have been ordered detained until FDA terminates the
detention under paragraph (j) of this section or the detention period
expires, whichever occurs first.
    (2) If detained drugs are not in final form for shipment, the
manufacturer may move them within the establishment where they are
detained to complete the work needed to put them in final form. As soon
as the drugs are moved for this purpose, the individual responsible for
their movement must orally notify the FDA representative who issued the
detention order, or another responsible district office official, of
the movement of the drugs. As soon as the drugs are put in final form,
they must be segregated from other drugs, and the individual
responsible for their movement must orally notify the FDA
representative who issued the detention order, or another responsible
district office official, of their new location. The drugs put in final
form must not be moved further without FDA approval.
    (3) The FDA representative who issued the detention order, or
another responsible district office official, may approve, in writing,
the movement of detained drugs for any of the following purposes:
    (i) To prevent interference with an establishment's operations or
harm to the drugs;
    (ii) To destroy the drugs;
    (iii) To bring the drugs into compliance;
    (iv) For any other purpose that the FDA representative who issued
the detention order, or other responsible district office official,
believes is appropriate in the case.
    (4) If an FDA representative approves the movement of detained
drugs under paragraph (h)(3) of this section, the detained drugs must
remain segregated from other drugs and the person responsible for their
movement must immediately orally notify the official who approved the
movement of the drugs, or another responsible FDA district office
official, of the new location of the detained drugs.
    (5) Unless otherwise permitted by the FDA representative who is
notified of, or who approves, the movement of drugs under this
paragraph, the required tags must accompany the drugs during and after
movement and must remain with the drugs until FDA terminates the
detention or the detention period expires, whichever occurs first.
    (i) Actions involving adulterated or misbranded drugs. If FDA
determines that the detained drugs, including any that have been put in
final form, are adulterated or misbranded, or both, it may initiate
legal action against the drugs or the responsible individuals, or both,
or request that the drugs be destroyed or otherwise brought into
compliance with the Federal Food, Drug, and Cosmetic Act under FDA's
supervision.
    (j) Detention termination. If FDA decides to terminate a detention
or when the detention period expires, whichever occurs first, an FDA
representative authorized to terminate a detention will issue a
detention termination notice releasing the drugs to any person who
received the original detention order or that person's representative
and will remove, or authorize in writing the removal of, the required
labels or tags.
    (k) Recordkeeping requirements. (1) After issuance of a detention
order under paragraph (d) of this section, the owner, operator, or
agent in charge of any factory, warehouse, other establishment, or
consulting laboratory where detained drugs are manufactured, processed,
packed, or held, must have, or establish, and maintain adequate records
relating to how the detained drugs may have become adulterated or
misbranded, records on any distribution of the drugs before and after
the detention period, records on the correlation of any in-process
detained drugs that are put in final form under paragraph (h) of this
section to the completed drugs, records of any changes in, or
processing of, the drugs permitted under the detention order, and
records of any other movement under paragraph (h) of this section.
Records required under this paragraph must be provided to FDA on
request for review and copying. Any FDA request for access to records
required under this paragraph must be made at a reasonable time, must
state the reason or purpose for the request, and must identify to the
fullest extent practicable the information or type of information
sought in the records to which access is requested.
    (2) Records required under this paragraph must be maintained for a
maximum period of 2 years after the issuance of the detention order or
for such other shorter period as FDA directs. When FDA terminates the
detention or when the detention period expires, whichever occurs first,
FDA will advise all persons required under this paragraph to keep
records concerning that detention whether further recordkeeping is
required for the remainder of the 2-year, or shorter, period. FDA
ordinarily will not require further recordkeeping if the Agency
determines that the drugs are not adulterated or misbranded or that
recordkeeping is not necessary to protect the public health, unless the
records are required under other regulations in this chapter (e.g., the
good manufacturing practice regulation in part 211 of this chapter).

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
4. The authority citation for 21 CFR part 16 is revised to read as
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467F, 679, 821, 1034; 42 U.S.C. 201-262, 263b, 364.

0
5. Revise the first sentence of Sec.  16.1 paragraph (b)(1) to read as
follows:

Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (1) Statutory provisions: Section 304(g) of the act relating to the
administrative detention of devices and drugs (see Sec. Sec.  800.55(g)
and 1.980(g) of this chapter).
* * * * *

    Dated: May 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12458 Filed 5-28-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 7 (Tuesday, January 11, 2022)]
[Rules and Regulations]
[Pages 1358-1360]
[FR Doc No: 2022-00030]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2021-0430; FRL-9060-02-R4]

Air Plan Approval; North Carolina; Minor Revisions to Cotton
Ginning Operations Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a
revision to the North Carolina State Implementation Plan (SIP)
submitted by the State of North Carolina Department of Environmental
Quality, Division of Air Quality, via a letter dated April 13, 2021,
and received by EPA on April 14, 2021. This revision contains minor
clarifying and typographical edits to North Carolina's cotton ginning
operations rule. EPA is finalizing approval of these changes pursuant
to the Clean Air Act (CAA or Act).

DATES: This rule is effective February 10, 2022.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2021-0430. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air and Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you contact the
person 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
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Pearlene Williams, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-9144. Ms. Williams can also be reached via electronic mail at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Overview

    On April 14, 2021, the State of North Carolina submitted changes to
the North Carolina SIP for EPA approval. EPA is approving these changes
to 15A North Carolina Administrative Code (NCAC) Subchapter 02D,\1\
Rule .0542--Control of Particulate Emissions from Cotton Ginning
Operations which establishes control requirements for particulate
emissions from cotton ginning operations.
---------------------------------------------------------------------------

    \1\ In the table of North Carolina regulations federally
approved into the SIP at 40 CFR 52.1770(c), 15A NCAC 02D is referred
to as ``Subchapter 2D Air Pollution Control Requirements.''
---------------------------------------------------------------------------

II. Analysis of North Carolina's SIP Revision

    North Carolina's SIP revision contains minor clarifying and
typographical edits to the text of Rule .0542.\2\ Details regarding the
background for these changes may be found in the notice of

proposed rulemaking that published September 24, 2021 (86 FR 53024).
The comment period for this rulemaking closed on October 25, 2021. No
comments were received. EPA has determined that these changes do not
interfere with attainment and maintenance of the national ambient air
quality standards or any other applicable requirement of the Act
because they are minor in nature. For these reasons, EPA is approving
the changes to this rule.
---------------------------------------------------------------------------

    \2\ See North Carolina's April 14, 2021, SIP revision at pp. 82-
86 (of the pdf file available in the docket for this rulemaking) to
review a redline version of the rule showing all changes.
---------------------------------------------------------------------------

III. Incorporation by Reference

    In this document, EPA is finalizing rule regulatory text that
includes incorporation by reference. In accordance with the
requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference 15A NCAC Subchapter 02D, Rule .0542--Control of Particulate
Emissions from Cotton Ginning Operations, with a state-effective date
of November 1, 2020. These changes are approved to make minor
clarifying and typographical edits to the rule. EPA has made, and will
continue to make, these materials generally available through
www.regulations.gov and at the EPA Region 4 office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).

IV. Final Action

    EPA is finalizing the aforementioned revisions to Rule .0542--
Control of Particulate Emissions from Cotton Ginning Operations. EPA is
approving these changes because they are consistent with the Clean Air
Act (CAA).

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by March 14, 2022. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Sulfur oxides, Volatile organic
compounds.

    Dated: December 29, 2021.
Daniel Blackman,
Regional Administrator, Region 4.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart II--North Carolina

0
2. In Sec.  52.1770, in paragraph (c), amend table 1, under ``Section
.0500 Emission Control Standards,'' by removing the entry for ``Section
.0542'' and adding an entry for ``Rule .0542'' in its place to read as
follows:

Sec.  52.1770   Identification of plan.

* * * * *
    (c) * * *

                                   (1) EPA Approved North Carolina Regulations
----------------------------------------------------------------------------------------------------------------
                                                               State
         State citation                Title/subject      effective date     EPA approval date      Explanation
----------------------------------------------------------------------------------------------------------------
                                Subchapter 2D Air Pollution Control Requirements
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                    Section .0500 Emission Control Standards
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Rule .0542......................  Control of Particulate       11/1/2020  1/11/2022, [Insert
                                   Emissions from Cotton                   citation of
                                   Ginning Operations.                     publication].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2022-00030 Filed 1-10-22; 8:45 am]
BILLING CODE 6560-50-P


                                 ATTACHMENT H

            Work Sheets used to Calculate Respondent Labor Costs
     This attachment is available as part of the electronic docket EPA-HQ-OPP-2021-0743
               and is part of the ICR's Supporting Statement.

Respondent Labor Costs (States, Tribes, Territories)

State Government (NAICS 999200)
 Item

                                    Formula

                                Labor Category

                                  Managerial
                                   Technical
                                   Clerical
Unloaded Hourly Rate[1]
 = W
                                    $46.69
                                    $31.60
                                    $21.63
Benefits Percentage[3]
Lb = B/W
                                    44.9%
                                    44.9%
                                    44.9%
Benefits per hour
B = W*Lb
                                    $20.97
                                    $14.19
                                    $9.72
Loaded Hourly Rate
Wb = W + B = W(1+Lb)
                                    $67.66
                                    $45.79
                                    $31.35
Overhead Percentage[4]
Lo = OH/Wb
                                      50%
                                      50%
                                      50%
Overhead per hour
OH = Wb*Lo
                                    $33.83
                                    $22.90
                                    $15.67
Fully Loaded Hourly Rate
Wf = Wb + OH
 = W + B + OH
                                   $101.49
                                    $68.69
                                    $47.02
 Source: Bureau of Labor Statistics, NAICS 999200  -  State Government, May 2020 data, http://www.bls.gov/oes/current/naics4_999200.htm, Last Modified Date: March 31, 2021
 Standard Occupational Codes:
   Management:  	11-0000, Management Occupations
   Technical:        	19-0000, Life Physical, and Social Science Occupations
   Administrative:          43-0000, Office, Clerical and Administrative Support Occupations
 Total benefits/wages based on June 2021Employer costs for employee compensation, All Civilian nonfarm workers, https://www.bls.gov/news.release/archives/ecec_09162021.pdf
 U.S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-452-02-001, January 2002, pp. 2-34.  The loading for indirect costs is within the range of 20-70% of the loaded labor rate (wage + benefits) suggested in EPA guidance.

     Work Sheets used to Calculate EPA and Federal Government Labor Costs
This attachment is available as part of the electronic docket EPA-HQ-OPP-2018-0418
                and is part of the ICR's Supporting Statement

EPA / Federal Government Labor Costs
Item
                                    Formula
                               Labor Category[2]

                                  Managerial
                                   Technical
                                Administrative
Unloaded Hourly Rate[1]
= W
                                    $63.67
                                    $42.00
                                    $23.24
Benefits Percentage[3]
Lb = B/W
                                    44.9%
                                    44.9%
                                    44.9%
Benefits per hour
B = W*Lb
                                    $28.60
                                    $18.86
                                    $10.44
Loaded Hourly Rate
Wb = W+B = W(1+Lb)
                                    $92.27
                                    $60.86
                                    $33.68
Overhead Percentage[4]
Lo = OH/Wb
                                      50%
                                      50%
                                      50%
Overhead per hour
OH = Wb*Lo
                                    $46.13
                                    $30.43
                                    $16.84
Fully Loaded Hourly Rate
Wf = Wb+OH = W+B+OH
                                   $138.40
                                    $91.30
                                    $50.52
 Data Source: Bureau of Labor Statistics, NAICS 999100  -  Federal Executive Branch, May 2020 data, http://www.bls.gov/oes/current/naics4_999100.htm, Last Modified Date: March 31, 2021
 Standard Occupational Codes:
   Management:  	11-0000, Management Occupations
   Technical:        	19-0000, Life Physical, and Social Science Occupations
   Administrative:          43-0000, Office, Clerical and Administrative Support Occupations
 Total benefits/wages based on June 2021Employer costs for employee compensation, All Civilian nonfarm workers, https://www.bls.gov/news.release/archives/ecec_09162021.pdf
 U.S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-452-02-001, January 2002, pp. 2-34.  The loading for indirect costs is within the range of 20-70% of the loaded labor rate (wage + benefits) suggested in EPA guidance.


[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Rules and Regulations]
[Pages 63674-63675]
[FR Doc No: 2015-26623]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 100, 117, 147, and 165

[USCG-2015-0242]

Quarterly Listings; Safety Zones, Security Zones, Special Local
Regulations, Drawbridge Operation Regulations and Regulated Navigation
Areas

AGENCY: Coast Guard, DHS.

ACTION: Notice of expired temporary rules issued.

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

SUMMARY: This document provides notice of substantive rules issued by
the Coast Guard that were made temporarily effective between January
2015 and March 2015 but expired before they could be published in the
Federal Register. This notice lists temporary safety zones, security
zones, special local regulations, drawbridge operation regulations and
regulated navigation areas, all of limited duration and for which
timely publication in the Federal Register was not possible.

DATES: This document lists temporary Coast Guard rules that became
effective between January 2015 and March 2015 and were terminated
before they could be published in the Federal Register.

ADDRESSES: Temporary rules listed in this document may be viewed
online, under their respective docket numbers, using the Federal
eRulemaking Portal at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For questions on this notice contact
Yeoman First Class Maria Fiorella Villanueva, Office of Regulations and
Administrative Law, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Coast Guard District Commanders and Captains
of the Port (COTP) must be immediately responsive to the safety and
security needs within their jurisdiction; therefore, District
Commanders and COTPs have been delegated the authority to issue certain
local regulations. Safety zones may be established for safety or
environmental purposes. A safety zone may be stationary and described
by fixed limits or it may be described as a zone around a vessel in
motion. Security zones limit access to prevent injury or damage to
vessels, ports, or waterfront facilities. Special local regulations are
issued to enhance the safety of participants and spectators at regattas
and other marine events. Drawbridge operation regulations authorize
changes to

drawbridge schedules to accommodate bridge repairs, seasonal vessel
traffic, and local public events. Regulated Navigation Areas are water
areas within a defined boundary for which regulations for vessels
navigating within the area have been established by the regional Coast
Guard District Commander.
    Timely publication of these rules in the Federal Register may be
precluded when a rule responds to an emergency, or when an event occurs
without sufficient advance notice. The affected public is, however,
often informed of these rules through Local Notices to Mariners, press
releases, and other means. Moreover, actual notification is provided by
Coast Guard patrol vessels enforcing the restrictions imposed by the
rule. Because Federal Register publication was not possible before the
end of the effective period, mariners were personally notified of the
contents of these safety zones, security zones, special local
regulations, regulated navigation areas or drawbridge operation
regulations by Coast Guard officials on-scene prior to any enforcement
action. However, the Coast Guard, by law, must publish in the Federal
Register notice of substantive rules adopted. To meet this obligation
without imposing undue expense on the public, the Coast Guard
periodically publishes a list of these temporary safety zones, security
zones, special local regulations, regulated navigation areas and
drawbridge operation regulations. Permanent rules are not included in
this list because they are published in their entirety in the Federal
Register. Temporary rules are also published in their entirety if
sufficient time is available to do so before they are placed in effect
or terminated.
    The following unpublished rules were placed in effect temporarily
during the period between January 2015 and March 2015 unless otherwise
indicated. To view copies of these rules, visit www.regulations.gov and
search by the docket number indicated in the list below.

----------------------------------------------------------------------------------------------------------------
                                                                                Effective
                Docket No.                           Location                       Type                 date
----------------------------------------------------------------------------------------------------------------
USCG-2014-1035...........................  Clearwater Beach, FL.......  Safety Zones (Parts 147 and   12/21/2014
                                                                         165).
USCG-2014-1033...........................  Wilmington, DE.............  Safety Zones (Parts 147 and    12/9/2014
                                                                         165).
USCG-2014-1046...........................  Miami, FL..................  Safety Zones (Parts 147 and   12/31/2014
                                                                         165).
USCG-2014-1010...........................  Oahu, HI...................  Security Zones (Part 165)..   12/18/2014
USCG-2014-0957...........................  Owensboro, KY..............  Security Zones (Part 165)..   10/21/2014
USCG-2014-1014...........................  St. Petersburg, FL.........  Safety Zones (Parts 147 and   12/25/2014
                                                                         165).
USCG-2014-1067...........................  Wilmington, NC.............  Safety Zones (Parts 147 and     1/8/2015
                                                                         165).
USCG-2014-0826...........................  Chicago, IL................  Safety Zones (Parts 147 and     9/5/2014
                                                                         165).
USCG-2014-0081...........................  Buffalo, NY................  Safety Zones (Parts 147 and     9/6/2014
                                                                         165).
USCG-2014-1058...........................  Tampa, FL..................  Safety Zones (Parts 147 and    1/11/2015
                                                                         165).
USCG-2014-0817...........................  Township, MI...............  Safety Zones (Parts 147 and     9/4/2014
                                                                         165).
USCG-2014-0810...........................  St. Clair Shores, MI.......  Safety Zones (Parts 147 and     9/6/2014
                                                                         165).
USCG-2014-0815...........................  Ecorse, MI.................  Safety Zones (Parts 147 and     9/2/2014
                                                                         165).
USCG-2014-0779...........................  Toledo, OH.................  Safety Zones (Parts 147 and    8/29/2014
                                                                         165).
USCG-2014-0682...........................  Cincinnati, OH.............  Safety Zones (Parts 147 and    8/31/2014
                                                                         165).
USCG-2014-0615...........................  Orange Beach, AL...........  Special Local Regulations      8/22/2014
                                                                         (Part 100).
USCG-2014-0595...........................  Cleveland, OH..............  Safety Zones (Parts 147 and    7/27/2014
                                                                         165).
USCG-2014-0346...........................  Ledbetter, KY..............  Safety Zones (Parts 147 and    4/27/2014
                                                                         165).
USCG-2014-1072...........................  Oak Island, NC.............  Safety Zones (Parts 147 and     1/4/2015
                                                                         165).
USCG-2015-0009...........................  Washington, DC.............  Security Zones (Part 165)..    1/20/2015
USCG-2015-0080...........................  Tracy, CA..................  Drawbridges (Part 117).....    2/11/2015
USCG-2015-0043...........................  Wilmington, NC.............  Safety Zones (Parts 147 and    1/23/2015
                                                                         165).
USCG-2015-0081...........................  Walnut Grove, CA...........  Drawbridges (Part 117).....    2/17/2015
USCG-2015-0091...........................  Queen Ann County, MD.......  Safety Zones (Parts 147 and    2/16/2015
                                                                         165).
USCG-2014-0989...........................  Mt. Vernon, IN.............  Safety Zones (Parts 147 and    12/1/2014
                                                                         165).
USCG-2014-1022...........................  Rockport, KY...............  Safety Zones (Parts 147 and    12/1/2014
                                                                         165).
USCG-2015-0124...........................  Fort Pierce, FL............  Safety Zones (Parts 147 and    2/26/2015
                                                                         165).
USCG-2015-0015...........................  Port NY Zone, NY...........  Safety Zones (Parts 147 and    2/17/2015
                                                                         165).
USCG-2015-0106...........................  Pacific Ocean, CA..........  Safety Zones (Parts 147 and    2/17/2015
                                                                         165).
USCG-2015-0147...........................  Wilmington, NC.............  Safety Zones (Parts 147 and     3/8/2015
                                                                         165).
USCG-2015-0026...........................  Los Angeles, CA............  Safety Zones (Parts 147 and    1/20/2015
                                                                         165).
USCG-2015-0089...........................  Naples, FL.................  Safety Zones (Parts 147 and     3/7/2015
                                                                         165).
USCG-2015-0033...........................  Alameda, CA................  Safety Zones (Parts 147 and     2/9/2015
                                                                         165).
USCG-2015-0032...........................  Tacoma, WA.................  Safety Zones (Parts 147 and    1/22/2015
                                                                         165).
USCG-2015-0077...........................  Miami, FL..................  Security Zones (Part 165)..    2/13/2015
USCG-2015-0047...........................  Fort Myers, FL.............  Security Zones (Part 165)..    1/30/2015
USCG-2014-0139...........................  Marcus Hook, PA............  Anchorages.................    3/20/2015
USCG-2015-0116...........................  San Francisco, CA..........  Safety Zones (Parts 147 and    3/21/2015
                                                                         165).
USCG-2015-0153...........................  Boston, MA.................  Security Zones (Part 165)..    3/29/2015
USCG-2015-0044...........................  Biloxi, MS.................  Safety Zones (Parts 147 and    3/27/2015
                                                                         165).
USCG-2015-0143...........................  New Orleans, LA............  Safety Zones (Parts 147 and    3/26/2015
                                                                         165).
USCG-2015-0160...........................  Pensacola, FL..............  Safety Zones (Parts 147 and    3/24/2015
                                                                         165).
USCG-2015-0173...........................  Fort Walton Beach, FL......  Safety Zones (Parts 147 and    3/11/2015
                                                                         165).
----------------------------------------------------------------------------------------------------------------

K. Kroutil,
Chief, Office of Regulations and Administrative Law.
[FR Doc. 2015-26623 Filed 10-20-15; 8:45 am]
 BILLING CODE P


CONSEQUENCES OF A RCRA DESIGNATION FOR BIOSLUDGE ° Biosludge management in tank trucks is subject to RCRA container standards, inspections and recordkeeping requirements ° Biosludge combustion is subject to extensive RCRA management requirements, recordkeeping and permitting. ° Uncertainty in RCRA requirements for 340 ton/ day waste stream   Biosludge dewatering processes are dependent on the wastewater treatment tank exclusion.

  Bevill Exclusion concerns affecting 31,000 tons of coal ash management   Limits flexibility in evaluating other waste management options ° Gasification ° Beneficial Use Opportunities ° Severe Testing limitations CONSEQUENCES OF A RCRA DESIGNATION FOR BIOSLUDGE Annual Operating Costs Associated with RCRA BIF Units 1. Additional equivalent personnel$ 500,000 a. 2 technical support personnel in powerhouse b. 2 environmental instrument analysts/ systems personnel c. 1 dedicated Environmental Affairs support person 2. Low metals coal premium$ 250,000  500,000 3. Low metals analyses$ 150,000 4. Bevill test cost for outside analyses$ 10,000 5. Systems materials maintenance$ 5,000 6. Continuous Emissions Monitors$ 60,000 maintenance materials 7. In house weekly & daily sludge$ 30,000 analyses 8. COC Testing$ 100,000 TOTAL ANNUAL COST$ 1,105,000  1,355,000 Annual Operating Costs Associated with RCRA BIF Units Remaining Costs for RCRA Permitting of BIF Units ° Risk Assessment data collection for 7 BIF units ( 3 sets of Risk Burns)

° Trial Burns for 7 BIF units ( 6 sets of Trial Burns)

° Risk and Trial Burn data evaluation and submittal,

risk analyses, establishing operation conditions and permit negotiation ° Permitting Fees ( proposed) °$ 500,000 °$ 700,000 °$ 500,000 °$ 150,000 Projected Compliance Cost for BIF MACT ° Installation of new APC equipment on 4 boilers ° Annual increased operating costs °$ 61,000,000 °$ 3,000,000 Aniline Bis(

2

ethylhexyl)

phthalate Di

butyl phthalate 1,2

dichlorobenzene Dimethyl phthalate Phenol PYRIDINE Benzene Chlorobenzene 1,1,2,2Tetrachlorethane Ethylbenzene 1,4

Dioxane Methanol TOLUENE Xylene % to Air % to Sludge % Treated0 10 20 30 40 50 60 70 80 90 100 Summary Chart  Removal Efficiency % to Air % to Sludge % Treated Percent Benzene Chlorobenzene 1,1,2,2Tetrachlorethane Sludge Without Grit TCLP Sludge w/ o Grit TOTAL Sludge TOTAL Influent 3,769 1,175 57 1.61 0.5 0.5 0 500 1000 1500 2000 2500 3000 3500 4000 Volatile Organics Chart 1 Sludge Without Grit TCLP Sludge w/ o Grit TOTAL Sludge TOTAL Influent Pounds per year Ethylbenzene 1,4

Dioxane Methanol TOLUENE Xylene Sludge w/ o Grit TCLP Sludge w/ o Grit TOTAL Sludge TOTAL Influent 41,000407,000 5,100,000 581,000 259,000 600 330625631,57732 312600.02 0.220.41 0 1000000 2000000 3000000 4000000 5000000 6000000 Volatile Organics Chart 2 Sludge w/ o Grit TCLP Sludge w/ o Grit TOTAL Sludge TOTAL Influent Pounds per year Aniline Bis(

2

ethylhexyl)

phthalate Di

butyl phthalate 1,2

dichlorobenzene Dimethyl phthalate Phenol PYRIDINE Sludge TCLP Sludge TOTAL Influent 10300 14500 11500 12000 43320 17100 2027 404 2500 1979 200 2.67 0.007 0.0150 5000 10000 15000 20000 25000 30000 35000 40000 45000 Semi Volatile Chart Sludge TCLP Sludge TOTAL Influent Pounds per year Antimony Arsenic Barium Chromium Lead Nickel Selenium Thallium Sludge TCLP Sludge TOTAL Influent 1,2041,528 11,600 13,000 4,350 8,200 1,107 855 734 7155,60011,800 2,0005,700 840 535 1.5 83170.2152 31 0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 Metals Chart 1 Sludge TCLP Sludge TOTAL Influent Pounds per year Beryllium Cadmium Mercury Silver Sludge TCLP Sludge TOTAL Influent 53 67 23 146 39 53 17 1100.033 0.165 0 1.8 0 20 40 60 80 100 120 140 160 Metals Chart 2 Sludge TCLP Sludge TOTAL Influent Pounds per Year