[Federal Register Volume 85, Number 57 (Tuesday, March 24, 2020)]
[Rules and Regulations]
[Pages 16549-16555]
[FR Doc No: 2020-05213]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 101, 112, 115, 117, 118, 507, and 800

[Docket No. FDA-2019-N-0011]

Office of Regulatory Affairs Division Director; Technical
Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
revising chapter I of its regulations. These revisions are necessary to
reflect changes to the Agency's organizational structure, including the
reorganization of the Office of Regulatory Affairs. The revisions
replace references to the District Director with references to the
Division Director and make other related changes. The rule does not
impose any new regulatory requirements on affected parties. This action
is editorial in nature and is intended to improve the accuracy of the
Agency's regulations.

DATES: This rule is effective March 24, 2020.

FOR FURTHER INFORMATION CONTACT: Holli Kubicki, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville,
MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Office of Regulatory Affairs (ORA) has reorganized to align
field activities by FDA-regulated commodity (e.g., food, drugs, medical
devices) or program area (e.g., imports). As a result, ORA division
officials now perform certain duties such as those related to
administrative appeals and informal hearings previously performed by
district officials. FDA regulations included numerous references to
district officials. The revisions made by this rule update these
references to division officials, but do not alter any substantive
standards.

II. Description of the Technical Amendments

    The regulations specified in this rule have been revised to replace
references to the ORA district official, including ``District
Director'', with references to the ORA division official, including
``Division Director'', to reflect the ORA program alignment. In
addition, we have made grammatical changes and minor conforming
amendments as necessary to accommodate the new terminology.
    We are making these technical amendments to revise descriptions of
the FDA officials designated to preside over administrative appeals and
at informal hearings on appeal, among other things. The amendments are
technical and editorial in nature and should not be construed as
modifying any substantive standards.

III. Notice and Public Comment

    Publication of this document constitutes final action of these
changes under the Administrative Procedure Act (APA) (5 U.S.C. 553).
Section 553 of the APA exempts ``rules of agency organization,
procedure, or practice'' from proposed rulemaking (i.e., notice and
comment rulemaking). 5 U.S.C. 553(b)(3)(A). Rules are also exempt when
an Agency finds ``good cause'' that notice and comment rulemaking
procedures would be ``impracticable, unnecessary, or contrary to the
public interest.'' 5 U.S.C. 553(b)(3)(B).
    FDA has determined that this rulemaking meets the notice and
comment exemption requirements in 5 U.S.C. 553(b)(3)(A) and (b)(3)(B).
FDA's revisions relate solely to FDA's change in organizational
structure and make only minor technical non-substantive changes that
pertain solely to the designation of FDA officials, and do not alter
any substantive standard. FDA does not believe public comment is
necessary for these minor revisions.
    The APA allows an effective date less than 30 days after
publication as ``provided by the agency for good cause found and
published with the rule'' (5 U.S.C. 553(d)(3)). A delayed effective
date is unnecessary in this case because the amendments do not impose
or alter any substantive requirements on affected parties. As a result,
affected parties do not need time to prepare before the rule takes
effect. Therefore, FDA finds good cause for the amendments to become
effective on the date of publication of this action.

List of Subjects

21 CFR Part 1

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

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

21 CFR Part 112

    Dietary foods, Food grades and standards, Foods, Fruits,
Incorporation by reference, Packaging and containers, Reporting and
recordkeeping requirements, Safety, Vegetables.

21 CFR Part 115

    Eggs and egg products, Foods.

21 CFR Part 117

    Food packaging, Foods.

21 CFR Part 118

    Eggs and egg products, Food grades and standards, Reporting and
recordkeeping requirements.

21 CFR Part 507

    Animal foods, Labeling, Packaging and containers, Reporting and
recordkeeping requirements.

21 CFR Part 800

    Administrative practice and procedure, Medical devices, Ophthalmic
goods and services, Packaging and containers, Reporting and
recordkeeping requirements.

    For the reasons stated in the preamble, the Food and Drug
Administration amends 21 CFR chapter I as set forth below:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 continues 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, 342, 343, 350c,
350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2,
362, 371, 373, 374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a,
387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188,
116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.

0
2. Amend Sec.  1.377 by revising the definition of ``Authorized FDA
representative'' to read as follows:

Sec.  1.377  What definitions apply to this subpart?

* * * * *
    Authorized FDA representative means an FDA Division Director in
whose division the article of food involved is located or an FDA
official senior to such director.
* * * * *

0
3. In Sec.  1.391, revise the first sentence to read as follows:

Sec.  1.391  Who approves a detention order?

    An authorized FDA representative must approve a detention order. *
* *

0
4. Amend Sec.  1.393 by revising paragraph (b)(12) to read as follows:

Sec.  1.393  What information must FDA include in the detention order?

* * * * *
    (b) * * *
    (12) The mailing address, telephone number, email address, fax
number, and the name of the FDA Division Director in whose division the
detained article of food is located;
* * * * *

0
5. Amend Sec.  1.402 by revising paragraph (a) introductory text to
read as follows:

Sec.  1.402  What are the requirements for submitting an appeal?

    (a) If you want to appeal a detention order, you must submit your
appeal in writing to the FDA Division Director in whose division the
detained article of food is located, at the mailing address, email
address, or fax number identified in the detention order according to
the following applicable timeframes:
* * * * *

0
6. Amend Sec.  1.403 by revising paragraphs (b) and (f) to read as
follows:

Sec.  1.403  What requirements apply to an informal hearing?

* * * * *
    (b) A request for a hearing under this section must be addressed to
the FDA Division Director in whose division the article of food
involved is located;
* * * * *
    (f) Section 1.404, rather than Sec.  16.42(a) of this chapter,
describes the FDA employees who preside at hearings under this subpart;
* * * * *

0
7. Revise Sec.  1.404 to read as follows:

Sec.  1.404  Who serves as the presiding officer for an appeal and for
an informal hearing?

    The presiding officer for an appeal, and for an informal hearing,
must be an Office of Regulatory Affairs Program Director or another FDA
official senior to an FDA Division Director.

0
8. Amend Sec.  1.980 by revising:
0
a. The first sentence of paragraph (c);
0
b. Paragraph (d)(3)(xi);
0
c. The first sentence of paragraph (e);
0
d. The second sentence of paragraph (g)(1);
0
e. Paragraphs (g)(3)(ii) and (iv) and (g)(4); and
0
f. Paragraphs (h)(2), (h)(3) introductory text, (h)(3)(iv), and (h)(4).
    The revisions read as follows:

Sec.  1.980  Administrative detention of drugs.

* * * * *
    (c) * * * 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 Division Director in whose division 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 Division Director may authorize detention for
10 additional calendar days. * * *
    (d) * * *
    (3) * * *
    (xi) The mailing address, telephone number, and name of the FDA
Division Director.
    (e) * * * A detention order, before issuance, must be approved by
the FDA Division Director in whose division the drugs are located. * *
*
    (g) * * *
    (1) * * * Any appeal must be submitted in writing to the FDA
Division Director in whose division the drugs are located within 5
working days of receipt of a detention order. * * *
    (3) * * *
    (ii) A request for a hearing under this section should be addressed
to the FDA Division Director;
* * * * *
    (iv) Paragraph (g)(4) of this section, rather than Sec.  16.42(a)
of this chapter, describes the FDA employees 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 an Office of
Regulatory Affairs Program Director or another FDA official senior to
an FDA Division Director who is permitted by Sec.  16.42(a) of this
chapter to preside over the hearing.
* * * * *
    (h) * * *
    (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 the purpose in the preceding sentence, the
individual responsible for their movement must orally notify the FDA
representative who issued the detention order, or another responsible
division 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 division 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 division office official, may approve, in writing,
the movement of detained drugs for any of the following purposes:
* * * * *
    (iv) For any other purpose that the FDA representative who issued
the detention order, or other responsible division 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 division office
official, of the new location of the detained drugs.
* * * * *

PART 101--FOOD LABELING

0
9. The authority citation for part 101 continues to read as follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
10. Amend Sec.  101.17 by revising paragraphs (h)(7)(i)(A) and (E)
introductory text, (h)(7)(ii)(A) through (C) introductory text, and
(h)(7)(ii)(F) to read as follows:

Sec.  101.17  Food labeling warning, notice, and safe handling
statements.

* * * * *
    (h) * * *
    (7) * * *
    (i) * * *
    (A) Order for relabeling, diversion, or destruction under the PHS
Act. Any division office of FDA or any State or locality acting under
paragraph (h)(6) of this section, upon finding shell eggs held in
violation of this section, may serve upon the person in whose
possession such eggs are found a written order that such eggs be
relabeled with the required statement in paragraph (h)(1) of this
section before further distribution. If the person chooses not to
relabel, the division office of FDA or, if applicable, the appropriate
State or local agency may serve upon the person a written order that
such eggs be diverted (from direct consumer sale, e.g., to food
service) under the supervision of an officer or employee of the issuing
entity, for processing in accordance with the EPIA (21 U.S.C. 1031 et
seq.) or destroyed by or under the supervision of the issuing entity,
within 10 working days from the date of receipt of the order.
* * * * *
    (E) Sale or other disposition of shell eggs under order. After
service of the order, the person in possession of the shell eggs that
are the subject of the order shall not sell, distribute, or otherwise
dispose of or move any eggs subject to the order unless and until the
notice is withdrawn after an appeal except, after notifying FDA's
division office or, if applicable, the State or local agency in
writing, to:
* * * * *
    (ii) * * *
    (A) Appeal of a detention order. Any appeal shall be submitted in
writing to the FDA Division Director in whose division the shell eggs
are located within 5 working days of the issuance of the order. If the
appeal includes a request for an informal hearing, the hearing shall be
held within 5 working days after the appeal is filed or, if requested
by the appellant, at a later date, which shall not be later than 20
calendar days after the issuance of the order. The order may also be
appealed within the same period of 5 working days by any other person
having an ownership or proprietary interest in such shell eggs. The
appellant of an order shall state the ownership or proprietary interest
the appellant has in the shell eggs.
    (B) Summary decision. A request for a hearing may be denied, in
whole or in part and at any time after a request for a hearing has been
submitted, if the Office of Regulatory Affairs Program Director or
another FDA official senior to an FDA Division Director determines that
no genuine and substantial issue of fact has been raised by the
material

submitted in connection with the hearing or from matters officially
noticed. If the presiding FDA official determines that a hearing is not
justified, written notice of the determination will be given to the
parties explaining the reason for denial.
    (C) Informal hearing. Appearance by any appellant at the hearing
may be by mail or in person, with or without counsel. The informal
hearing shall be conducted by an Office of Regulatory Affairs Program
Director or another FDA official senior to an FDA Division Director,
and a written summary of the proceedings shall be prepared by the
presiding FDA official.
* * * * *
    (F) No appeal. If there is no appeal of the order and the person in
possession of the shell eggs that are subject to the order fails to
relabel, divert, or destroy them within 10 working days, or if the
demand is affirmed by the presiding FDA official after an appeal and
the person in possession of such eggs fails to relabel, divert, or
destroy them within 10 working days, the FDA division office, or, if
applicable, the State or local agency may designate an officer or
employee to divert or destroy such eggs. It shall be unlawful to
prevent or to attempt to prevent such diversion or destruction of the
shell eggs by the designated officer or employee.
* * * * *

PART 112--STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND
HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

0
11. The authority citation for part 112 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243,
264, 271.

0
12. Amend Sec.  112.202 by revising paragraph (a) to read as follows:

Sec.  112.202  What procedure will FDA use to withdraw an exemption?

    (a) An FDA Division Director in whose division the farm is located
(or, in the case of a foreign farm, the Director of the Office of
Compliance in the Center for Food Safety and Applied Nutrition), or an
FDA official senior to either such Director, must approve an order to
withdraw the exemption before the order is issued.
* * * * *

0
13. Amend Sec.  112.203 by revising paragraph (h) to read as follows:

Sec.  112.203  What information must FDA include in an order to
withdraw a qualified exemption?

* * * * *
    (h) The mailing address, telephone number, email address, fax
number, and name of the FDA Division Director in whose division the
farm is located (or for foreign farms, the same information for the
Director of the Office of Compliance in the Center for Food Safety and
Applied Nutrition); and
* * * * *

0
14. Amend Sec.  112.206 by revising paragraph (a)(1) to read as
follows:

Sec.  112.206  What is the procedure for submitting an appeal?

    (a) * * *
    (1) Submit the appeal in writing to the FDA Division Director in
whose division the farm is located (or in the case of a foreign farm,
the Director of the Office of Compliance in the Center for Food Safety
and Applied Nutrition), at the mailing address, email address, or fax
number identified in the order within 15 calendar days of the date of
receipt of the order; and
* * * * *

0
15. Amend Sec.  112.208 by revising paragraph (c)(2) to read as
follows:

Sec.  112.208  What requirements are applicable to an informal hearing?

* * * * *
    (c) * * *
    (2) A request for a hearing under this subpart must be addressed to
the FDA Division Director (or, in the case of a foreign farm, the
Director of the Office of Compliance in the Center for Food Safety and
Applied Nutrition) as provided in the order withdrawing an exemption.
* * * * *

0
16. Revise Sec.  112.209 to read as follows:

Sec.  112.209  Who is the presiding officer for an appeal and for an
informal hearing?

    The presiding officer for an appeal, and for an informal hearing,
must be an Office of Regulatory Affairs Program Director or another FDA
official senior to an FDA Division Director.

0
17. Amend Sec.  112.213 by revising paragraphs (a) and (b)(1) to read
as follows:

Sec.  112.213  If my qualified exemption is withdrawn, under what
circumstances would FDA reinstate my qualified exemption?

    (a) If the FDA Division Director in whose division your farm is
located (or, in the case of a foreign farm, the Director of the Office
of Compliance in the Center for Food Safety and Applied Nutrition)
determines that the farm has adequately resolved any problems with the
conduct and conditions that are material to the safety of the food
produced or harvested at such farm, and that continued withdrawal of
the exemption is not necessary to protect the public health or prevent
or mitigate a foodborne illness outbreak, the FDA Division Director in
whose division your farm is located (or, in the case of a foreign farm,
the Director of the Office of Compliance in the Center for Food Safety
and Applied Nutrition) will, on his or her own initiative or at the
request of a farm, reinstate the qualified exemption.
    (b) * * *
    (1) Submit a request, in writing, to the FDA Division Director in
whose division your farm is located (or, in the case of a foreign farm,
the Director of the Office of Compliance in the Center for Food Safety
and Applied Nutrition); and
* * * * *

PART 115--SHELL EGGS

0
18. The authority citation for part 115 continues to read as follows:

    Authority: 21 U.S.C. 342, 371; 42 U.S.C. 243, 264, 271.

0
19. Amend Sec.  115.50 by revising paragraphs (e)(1)(i) and (iii),
(e)(1)(v) introductory text, (e)(2)(i) through (iii) introductory text,
and (e)(2)(vi) to read as follows:

Sec.  115.50  Refrigeration of shell eggs held for retail distribution.

* * * * *
    (e) * * *
    (1) * * *
    (i) Order for diversion or destruction. Any division office of FDA
or any State or local agency acting under paragraph (d) of this
section, upon finding shell eggs held in violation of this section, may
serve upon the person in whose possession such eggs are found a written
order that such eggs be diverted, under the supervision of an officer
or employee of the issuing entity, for processing in accordance with
the EPIA (21 U.S.C. 1031 et seq.) or destroyed by or under the
supervision of said division office, within 10 working days from the
date of receipt of the order.
* * * * *
    (iii) Approval of Division Director. An order, before issuance,
shall be approved by the FDA Division Director in whose division the
shell eggs are located. If prior written approval is not feasible,
prior oral approval shall be obtained and confirmed by written
memorandum as soon as possible.
* * * * *
    (v) Sale or other disposition of shell eggs under order. After
service of the order, the person in possession of the

shell eggs that are the subject of the order shall not sell,
distribute, or otherwise dispose of or move any eggs subject to the
order unless and until the notice is withdrawn after an appeal except,
after notifying FDA's division office or, if applicable, the State or
local agency in writing, to:
* * * * *
    (2) * * *
    (i) Appeal of a detention order. Any appeal shall be submitted in
writing to FDA's Division Director in whose division the shell eggs are
located within 5 working days of the issuance of the order. If the
appeal includes a request for an informal hearing, the hearing shall be
held within 5 working days after the appeal is filed or, if requested
by the appellant, at a later date, which shall not be later than 20
calendar days after the issuance of the order. The order may also be
appealed within the same period of 5 working days by any other person
having an ownership or proprietary interest in such shell eggs. The
appellant of an order shall state the ownership or proprietary interest
the appellant has in the shell eggs.
    (ii) Summary decision. A request for a hearing may be denied, in
whole or in part and at any time after a request for a hearing has been
submitted, if the Office of Regulatory Affairs Program Director or
another FDA official senior to an FDA Division Director determines that
no genuine and substantial issue of fact has been raised by the
material submitted in connection with the hearing or from matters
officially noticed. If the presiding FDA official determines that a
hearing is not justified, written notice of the determination will be
given to the parties explaining the reason for denial.
    (iii) Informal hearing. Appearance by any appellant at the hearing
may be by mail or in person, with or without counsel. The informal
hearing shall be conducted by the Office of Regulatory Affairs Program
Director or another FDA official senior to an FDA Division Director,
and a written summary of the proceedings shall be prepared by the
presiding FDA official.
* * * * *
    (vi) No appeal. If there is no appeal of the order and the person
in possession of the shell eggs that are subject to the order fails to
divert or destroy them within 10 working days, or if the demand is
affirmed by the presiding FDA official after an appeal and the person
in possession of such eggs fails to divert or destroy them within 10
working days, FDA's division office or appropriate State or local
agency may designate an officer or employee to divert or destroy such
eggs. It shall be unlawful to prevent or to attempt to prevent such
diversion or destruction of the shell eggs by the designated officer or
employee.
* * * * *

PART 117--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND
RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

0
20. The authority citation for part 117 continues to read as follows:

    Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note,
371, 374; 42 U.S.C. 243, 264, 271.

0
21. Amend Sec.  117.254 by revising paragraph (a) to read as follows:

Sec.  117.254  Issuance of an order to withdraw a qualified facility
exemption.

    (a) An FDA Division Director in whose division the qualified
facility is located (or, in the case of a foreign facility, the
Director of the Office of Compliance in the Center for Food Safety and
Applied Nutrition), or an FDA official senior to either such Director,
must approve an order to withdraw the exemption before the order is
issued.
* * * * *

0
22. Amend Sec.  117.257 by revising paragraph (h) to read as follows:

Sec.  117.257  Contents of an order to withdraw a qualified facility
exemption.

* * * * *
    (h) The mailing address, telephone number, email address, fax
number, and name of the FDA Division Director in whose division the
facility is located (or, in the case of a foreign facility, the same
information for the Director of the Office of Compliance in the Center
for Food Safety and Applied Nutrition); and
* * * * *

0
23. Amend Sec.  117.264 by revising paragraph (a)(1) to read as
follows:

Sec.  117.264  Procedure for submitting an appeal.

    (a) * * *
    (1) Submit the appeal in writing to the FDA Division Director in
whose division the facility is located (or, in the case of a foreign
facility, the Director of the Office of Compliance in the Center for
Food Safety and Applied Nutrition), at the mailing address, email
address, or fax number identified in the order within 15 calendar days
of the date of receipt of confirmation of the order; and
* * * * *

0
24. Amend Sec.  117.270 by revising paragraph (c)(2) to read as
follows:

Sec.  117.270  Requirements applicable to an informal hearing.

* * * * *
    (c) * * *
    (2) A request for a hearing under this subpart must be addressed to
the FDA Division Director (or, in the case of a foreign facility, the
Director of the Office of Compliance in the Center for Food Safety and
Applied Nutrition) as provided in the order withdrawing an exemption.
* * * * *

0
25. Revise Sec.  117.274 to read as follows:

Sec.  117.274  Presiding officer for an appeal and for an informal
hearing.

    The presiding officer for an appeal, and for an informal hearing,
must be an Office of Regulatory Affairs Program Director or another FDA
official senior to an FDA Division Director.

0
26. Amend Sec.  117.287 by revising paragraphs (a) and (b)(1) to read
as follows:

Sec.  117.287  Reinstatement of a qualified facility exemption that was
withdrawn.

    (a) If the FDA Division Director in whose division your facility is
located (or, in the case of a foreign facility, the Director of the
Office of Compliance in the Center for Food Safety and Applied
Nutrition) determines that a facility has adequately resolved any
problems with the conditions and conduct that are material to the
safety of the food manufactured, processed, packed, or held at the
facility and that continued withdrawal of the exemption is not
necessary to protect public health and prevent or mitigate a foodborne
illness outbreak, the FDA Division Director in whose division your
facility is located (or, in the case of a foreign facility, the
Director of the Office of Compliance in the Center for Food Safety and
Applied Nutrition) will, on his or her own initiative or on the request
of a facility, reinstate the exemption.
    (b) * * *
    (1) Submit a request, in writing, to the FDA Division Director in
whose division your facility is located (or, in the case of a foreign
facility, the Director of the Office of Compliance in the Center for
Food Safety and Applied Nutrition); and
* * * * *

PART 118--PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS

0
27. The authority citation for part 118 continues to read as follows:

    Authority: 21 U.S.C. 321, 331-334, 342, 371, 381, 393; 42 U.S.C.
243, 264, 271.

0
28. Amend Sec.  118.12 by revising:
0
a. Paragraph (a)(1)(i) introductory text;
0
b. Paragraphs (a)(1)(ii) and (iv) introductory text; and
0
c. Paragraphs (a)(2)(i) through (iii) introductory text and (vi).
    The revisions read as follows:

Sec.  118.12  Enforcement and compliance.

    (a) * * *
    (1) * * *
    (i) Order for diversion or destruction under the PHS Act. Any
division office of FDA or any State or locality acting under paragraph
(c) of this section, upon finding shell eggs that have been produced or
held in violation of this part, may serve a written order upon the
person in whose possession the eggs are found requiring that the eggs
be diverted, under the supervision of an officer or employee of the
issuing entity, for processing in accordance with the EPIA (21 U.S.C.
1031 et seq.) or by a treatment that achieves at least a 5-log
destruction of SE or destroyed by or under the supervision of the
issuing entity, within 10 working days from the date of receipt of the
order, unless, under paragraph (a)(2)(iii) of this section, a hearing
is held, in which case the eggs must be diverted or destroyed
consistent with the decision of the Office of Regulatory Affairs
Program Director or another FDA official senior to an FDA Division
Director under paragraph (a)(2)(v) of this section. The order must
include the following information:
* * * * *
    (ii) Approval of Division Director. An order, before issuance, must
be approved by FDA's Division Director. If prior written approval is
not feasible, prior oral approval must be obtained and confirmed by
written memorandum as soon as possible.
* * * * *
    (iv) Sale or other disposition of shell eggs under order. After
service of the order, the person in possession of the shell eggs that
are the subject of the order must not sell, distribute, or otherwise
dispose of or move any eggs subject to the order unless and until
receiving a notice that the order is withdrawn after an appeal except,
after notifying FDA's division office or, if applicable, the State or
local representative, in writing, to:
* * * * *
    (2) * * *
    (i) Appeal of a detention order. Any appeal must be submitted in
writing to FDA's Division Director in whose division the shell eggs are
located within 5 working days of the issuance of the order. If the
appeal includes a request for an informal hearing, the hearing must be
held within 5 working days after the appeal is filed or, if requested
by the appellant, at a later date, which must not be later than 20
calendar days after the issuance of the order. The order may also be
appealed within the same period of 5 working days by any other person
having an ownership or proprietary interest in such shell eggs. The
appellant of an order must state the ownership or proprietary interest
the appellant has in the shell eggs.
    (ii) Summary decision. A request for a hearing may be denied, in
whole or in part and at any time after a request for a hearing has been
submitted, if the Office of Regulatory Affairs Program Director or
another FDA official senior to an FDA Division Director determines that
no genuine and substantial issue of fact has been raised by the
material submitted in connection with the hearing or from matters
officially noticed. If the presiding FDA official determines that a
hearing is not justified, written notice of the determination will be
given to the parties explaining the reason for denial.
    (iii) Informal hearing. Appearance by any appellant at the hearing
may be by mail or in person, with or without counsel. The informal
hearing must be conducted by the Office of Regulatory Affairs Program
Director or another FDA official senior to an FDA Division Director,
and a written summary of the proceedings must be prepared by the
presiding FDA official.
* * * * *
    (vi) No appeal. If there is no appeal of the order and the person
in possession of the shell eggs that are subject to the order fails to
divert or destroy them within 10 working days, or if the demand is
affirmed by the presiding FDA official after an appeal and the person
in possession of such eggs fails to divert or destroy them within 10
working days, FDA's division office or, if applicable, the State or
local representative may designate an officer or employee to divert or
destroy such eggs. It shall be unlawful to prevent or to attempt to
prevent such diversion or destruction of the shell eggs by the
designated officer or employee.
* * * * *

PART 507--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND
RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS

0
29. The authority citation for part 507 continues to read as follows:

    Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note,
371, 374; 42 U.S.C. 243, 264, 271.

0
30. Amend Sec.  507.62 by revising paragraph (a) to read as follows:

Sec.  507.62  Issuance of an order to withdraw a qualified facility
exemption.

    (a) An FDA Division Director in whose division the qualified
facility is located (or, in the case of a foreign facility, the
Director of the Division of Compliance in the Center for Veterinary
Medicine), or an FDA official senior to either such Director, must
approve an order to withdraw the exemption before the order is issued.
* * * * *

0
31. Amend Sec.  507.65 by revising paragraph (h) to read as follows:

Sec.  507.65  Contents of an order to withdraw a qualified facility
exemption.

* * * * *
    (h) The mailing address, telephone number, email address, fax
number, and name of the FDA Division Director in whose division the
facility is located (or, in the case of a foreign facility, the same
information for the Director of the Division of Compliance in the
Center for Veterinary Medicine); and
* * * * *

0
32. Amend Sec.  507.69 by revising paragraph (a)(1) to read as follows:

Sec.  507.69  Procedure for submitting an appeal.

    (a) * * *
    (1) Submit the appeal in writing to the FDA Division Director in
whose division the facility is located (or, in the case of a foreign
facility, the Director of the Division of Compliance in the Center for
Veterinary Medicine), at the mailing address, email address, or fax
number identified in the order within 15 calendar days of the date of
receipt of confirmation of the order; and
* * * * *

0
33. Amend Sec.  507.73 by revising paragraph (c)(2) to read as follows:

Sec.  507.73  Requirements applicable to an informal hearing.

* * * * *

    (c) * * *
    (2) A request for a hearing under this subpart must be addressed to
the FDA Division Director (or, in the case of a foreign facility, the
Director of the Division of Compliance in the Center for Veterinary
Medicine) as provided in the order withdrawing an exemption.
* * * * *

0
34. Revise Sec.  507.75 to read as follows:

Sec.  507.75  Presiding officer for an appeal and for an informal
hearing.

    The presiding officer for an appeal, and for an informal hearing,
must be an Office of Regulatory Affairs Program Director or another FDA
official senior to an FDA Division Director.

0
35. Amend Sec.  507.85 by revising paragraphs (a) and (b)(1) to read as
follows:

Sec.  507.85  Reinstatement of a qualified facility exemption that was
withdrawn.

    (a) If the FDA Division Director in whose division your facility is
located (or, in the case of a foreign facility, the Director of the
Division of Compliance in the Center for Veterinary Medicine)
determines that a facility has adequately resolved any problems with
the conditions and conduct that are material to the safety of the
animal food manufactured, processed, packed, or held at the facility
and that continued withdrawal of the exemption is not necessary to
protect public (human and animal) health and prevent or mitigate a
foodborne illness outbreak, the FDA Division Director in whose division
your facility is located (or, in the case of a foreign facility, the
Director of the Division of Compliance in the Center for Veterinary
Medicine) will, on his or her own initiative or on the request of a
facility, reinstate the exemption.
    (b) * * *
    (1) Submit a request, in writing, to the FDA Division Director in
whose division your facility is located (or, in the case of a foreign
facility, the Director of the Division of Compliance in the Center for
Veterinary Medicine); and
* * * * *

PART 800--GENERAL

0
36. The authority citation for part 800 continues to read as follows:

    Authority: 5 U.S.C. 551-559; 21 U.S.C. 301-399f.

0
37. Amend Sec.  800.55 by:
0
a. Revising the first sentence of paragraph (c), paragraph (d)(3)(xi),
the first sentence of paragraph (e), the second sentence of paragraph
(g)(1), and paragraphs (g)(3)(ii) and (iv) and (g)(4);
0
b. Adding a heading for paragraph (h); and
0
c. Revising paragraphs (h)(1), (2), and (3) introductory text,
(h)(3)(iv), and (h)(4).
    The revisions and addition read as follows:

Sec.  800.55  Administrative detention.

* * * * *
    (c) * * * 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 Division Director in whose division the devices are located
determines that a greater period is required to seize the devices, to
institute injunction proceedings, or to evaluate the need for legal
action, in which case the Division Director may authorize detention for
10 additional calendar days. * * *
    (d) * * *
    (3) * * *
    (xi) The mailing address, telephone number, and name of the FDA
Division Director.
    (e) * * * A detention order, before issuance, shall be approved by
the FDA Division Director in whose division the devices are located. *
* *
    (g) * * *
    (1) * * * Any appeal shall be submitted in writing to the FDA
Division Director in whose division the devices are located within 5
working days of receipt of a detention order.
    (3) * * *
    (ii) A request for a hearing under this section should be addressed
to the FDA Division Director.
* * * * *
    (iv) Paragraph (g)(4) of this section, rather than Sec.  16.42(a)
of this chapter, describes the FDA employees who preside at hearings
under this section.
    (4) The presiding officer of a regulatory hearing on an appeal of a
detention order, who also shall decide the appeal, shall be an Office
of Regulatory Affairs Program Director or another FDA official senior
to an FDA Division Director who is permitted by Sec.  16.42(a) of this
chapter to preside over the hearing.
* * * * *
    (h) Movement of detained devices. (1) Except as provided in this
paragraph (h), no person shall move detained devices 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 devices 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 devices are moved for the purpose of the preceding sentence, the
individual responsible for their movement shall orally notify the FDA
representative who issued the detention order, or another responsible
division office official, of the movement of the devices. As soon as
the devices are put in final form, they shall be segregated from other
devices, and the individual responsible for their movement shall orally
notify the FDA representative who issued the detention order, or
another responsible division office official, of their new location.
The devices put in final form shall not be moved further without FDA
approval.
    (3) The FDA representative who issued the detention order, or
another responsible division office official, may approve, in writing,
the movement of detained devices for any of the following purposes:
* * * * *
    (iv) For any other purpose that the FDA representative who issued
the detention order, or other responsible division office official,
believes is appropriate in the case.
    (4) If an FDA representative approves the movement of detained
devices under paragraph (h)(3) of this section, the detained devices
shall remain segregated from other devices and the person responsible
for their movement shall immediately orally notify the official who
approved the movement of the devices, or another responsible FDA
division office official, of the new location of the detained devices.
* * * * *

    Dated: March 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05213 Filed 3-23-20; 8:45 am]
BILLING CODE 4164-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

REGION III

1650 Arch Street

Philadelphia, Pennsylvania 19103-2029

DATE:

	February 6, 2009

SUBJECT:

	Technical Support Document for the District of Columbia, Reasonably
Available Control Technology Under the 8-hour Ozone National Ambient Air
Quality Standard

 FROM:

	Patrick J. Egan, Environmental Protection Specialist

Air Quality Planning Branch (3AP21)

TO:

REVIEWED BY:	SIP Docket File

            /s/

Cristina Fernandez, Branch Chief

Air Quality Planning Branch (3AP21)

I.	Affected Regulation

The revision to the District of Columbia State Implementation Plan
(SIP), received by EPA on September 22, 2008, applies to the
demonstration that the District of Columbia has implemented all the
necessary requirements of Reasonably Available Control Technology (RACT)
set forth by the federal Clean Air Act (CAA).  This determination is
necessary because section 184 of the CAA requires that areas within the
Ozone Transport Region (OTR) perform certain moderate nonattainment
requirements, regardless of the ozone designation or classification of
the particular area.

II.	 Background

Ozone is formed in the atmosphere by photochemical reactions between
volatile organic compounds (VOC), oxides of nitrogen (NOx) and carbon
monoxide (CO) in the presence of sunlight.  In order to reduce ozone
concentrations in the ambient air, the CAA requires all nonattainment
areas to apply control on VOC/NOx emission sources to achieve emission
reductions.  Among effective control measures, RACT controls are a major
group for reducing VOC and NOx emissions from stationary sources.

The District of Columbia is part of the OTR.  The OTR is established by
section 184 of the CAA.  Areas under the OTR are subject to OTR-specific
RACT requirements. Under the 1-hour ozone NAAQS, the District of
Columbia was originally classified as part of the Metropolitan
Washington serious 1-hour ozone nonattainment area located in OTR (56 FR
56694 at 56844, November 6, 1991).  As part of the planning process,
section 182(b)(2) of the CAA required the District of Columbia to
implement RACT on all sources and source categories covered by a CTG
issued by EPA.  Point sources with the potential to emit 50 tons per
year or more of VOCs or 100 tons per year or more of NOx that were not
covered by a CTG were also required to implement RACT.  As a result of
failure to meet the attainment date of November 15, 1999, the
Metropolitan Washington area was reclassified as a severe nonattainment
area for the 1-hour standard (68 FR 3410 at 3425, January 24, 2003).  As
a result of the reclassification, the District of Columbia was required
to perform RACT evaluations on point sources with the potential to emit
25 tons per year for either VOC (62 FR 11334, March 12, 1997) or NOx (69
FR 48150, August 9, 2004).

On July 18, 1997, EPA promulgated the new 8-hour NAAQS for ozone (62 FR
38856, July 18, 1997).  Under the 8-hour ozone NAAQS, the Metropolitan
Washington Area was designated nonattainment for the 8-hour ozone
standard and classified as a moderate nonattainment area.

On March 7, 2007, the District of Columbia Department of Environment
(DDOE) submitted a SIP revision for the District of Columbia in order to
recertify RACT as part of the 8-hour ozone NAAQS planning process for
the Metropolitan Washington Area and the requirements of section 184 of
the CAA must be satisfied.

At that time DDOE was requesting EPA approval of the SIP revision.
However the SIP Revision submitted on March 7, 2007, contained the word
“proposal” on the first page and thus could not be approved by EPA.
Therefore, on August 11, 2008, DDOE requested a withdrawal of the March
7, 2007 submittal.  DDOE also requested return of the SIP submittal
package at that time.  On August 28, 2008, DDOE received the SIP
revision package.  The word “proposal” was replaced with the word
“final” and the SIP package was received on September 22, 2008.

The first requirement, contained in section 184(b)(1)(B), requires the
implementation of RACT with respect to all sources of VOC covered by a
CTG.  The second requirement, set forth in section 184(b)(2), requires
the implementation of major stationary source requirements as if the
area were a moderate nonattainment area on any stationary source with a
potential to emit of at least 25 tons per year of VOC or 100 tons per
year of NOx.

Since the District of Columbia is part of the OTR, DDOE submitted this
SIP revision to demonstrate that all requirements for RACT are met,
either through certification that previously required RACT controls
represent RACT for 8-hour implementation purposes, through new or
amended RACT determinations, or by demonstrating that no facilities
exist in the District of Columbia that are applicable to CTG categories.

Since the 1970's, EPA has consistently interpreted RACT to mean the
lowest emission limit that a particular source is capable of meeting by
the application of the control technology that is reasonably available
considering technological and economic feasibility.  See, e.g., 72 FR
20586 at 20610 (April 25, 2007).  Section 182 of the CAA sets forth two
separate RACT requirements for ozone nonattainment area.  The first
requirement, contained in section 182(a)(2)(A) of the CAA, and referred
to as RACT fix-up, requires the correction of RACT rules for which the
EPA identified deficiencies before the CAA was amended in 1990.  The
second requirement, set forth in section 182(b)(2) of the CAA, requires
that moderate (or worse) ozone nonattainment areas, as well as marginal
and attainment areas the OTR established pursuant to section 184 of the
CAA, implement RACT controls on all major VOC and NOx emission sources
and on all sources and source categories covered by a CTG issued by EPA.

NOx RACT Controls

District of Columbia Municipal Regulations (DCMR) Chapter 8 Section 805
contains District of Columbia’s NOx RACT controls that were
implemented and approved into the District of Columbia’s SIP under the
1-hour ozone SIP.  Table 1 lists District of Columbia’s NOx RACT
controls:

Table 1	District of Columbia’s NOx RACT Controls

Regulation 20 DCMR - 	Title of Regulation	State Effective Date	Federal
Effective Date	Federal Register Notice

805.1	Fuel-burning equipment with an input capacity of 100 MM Btu/hr or
greater	4/16/04	12/28/04	69 FR 77645

805.5 & 805.8	Fuel-burning equipment with an input capacity equal to or
greater than 20MM/Btu/hr, but less than 50 MM Btu/hr	4/16/04	12/29/04	69
FR 77645

805.1 & 805.8	Fuel-burning equipment with an input capacity equal to or
greater than 50 MM/Btu/hr, but less than 100 MM Btu	4/16/04	12/28/04	69
FR 77645

805.4	Combustion turbine with an input capacity equal to or greater than
100 MM	4/16/04	12/28/04	69 FR 77645

805.1 & 709.1	Asphalt concrete plant with a pPTE 25 tons per year or
greater	4/16/04	12/28/04	69 FR 77645

805.1	All other fuel burning equipment with a PTE of 25 tons per year of
NOx or greater	4/16/04	12/28/04	69 FR 77645

805.1	Stationary Internal Combustion Engines	4/16/04	12/28/04	69 FR
77645

VOC RACT Controls

The District of Columbia’s Regulations and Statues, under 20 DCMR
Chapter 7, contain the District’s VOC RACT controls that were
implemented and approved in the District SIP under the 1-hour ozone
NAAQS.  Table 2 lists District of Columbia’s VOC RACT controls.

Table 2	District of Columbia’s VOC RACT Controls

Regulation

20-DCMR-	Existing Stationary Sources

	Title of Regulation	State Effective Date	Federal Register Date	Citation

715 and 716	Offset Lithography	10/2/98	10/27/99	64 FR 57777

704	Stage I Vapor Recovery	3/15/85	10/27/99 	64 FR 57777

708 and 742 	Solvent Cleaning Degreasing	3/15/85 	10/27/99

	64 FR 57777

718	Paint – Spray Booth	11/26/04	12/23/04	69 FR 76855

706	Petroleum Dry Cleaners	3/15/85	10/27/99	64 FR 57777

709.1	Cutback Asphalt	3/15/85	10/27/99	64 FR 57777

704.4	Leaks from Gasoline Tank Trucks and Vapor Collection Systems
3/15/85	10/27/99	64 FR 5777

710	Engraving and Plate Printing	3/15/85	8/4/92	57 FR 34249

705.4 – 705.14	Stage II Gasoline Vapor Recovery 	3/15/85	10/27/99	64
FR 57777

Although Alternate Control Techniques (ACTs) are not regulatory
documents and have no legal effect on state regulations, EPA requires
that states verify that ACTs have been considered in the RACT program
development process.  Therefore, DDOE included ACTs in their review of
applicable RACT requirements in this submittal.

 DDOE also submitted a negative declaration that the following VOC CTG
major sources do not exist in the District of Columbia.  The
determination was made after review of the existing registration
database for the counties comprising the 8-hour ozone nonattainment area
in the Metropolitan Washington, D.C. area.  Table 3 lists the District
of Columbia’s negative declaration for VOC CTG major sources.

Table 3 – Documents for which no Applicable Sources Exist in the
District of Columbia

Document Title

Automobile and light-duty truck manufacturing

Coating of cans, coils, paper, fabric and vinyl, metal furniture, large
applicances, magnet wire, miscellaneous metal parts and products and
flatwood paneling

Storage of petroleum liquids in fixed-roof tanks

Bulk gasoline plants

Petroleum refinery sources

Manufacture of synthesized pharmaceutical products, pneumatic rubber
tires, vegetable oil, synthetic organic chemicals (fugitive VOCs and air
oxidation) and high density polyethylene, polypropylene and polystyrene
resins

Graphic Arts Systems

Storage, transportation and marketing of VOCs (fugitive VOCs from oil
and gas production and natural gas and gasoline processing)

Aerospace

Shipbuilding and repair

Distillation or reactor or batch processees in the synthetic organic
chemical manufacturing industry

Wood furniture coatings

Storage of petroleum liquids in external floating-roof tanks

Bulk gasoline terminals

Petroleum refinery equipment leaks

III.       Evaluation

The District of Columbia’s SIP revision contains the requirements of
RACT set forth by the CAA under the 8-hour ozone NAAQS.  This SIP
revision for the District of Columbia satisfies the 8-hour RACT
requirements through (1) certification that previously adopted RACT
controls in the District of Columbia’s SIP that were approved by EPA
under the 1-hour ozone NAAQS are based on the currently available
technically and economically feasible controls, and that they continue
to represent RACT for the 8-hour implementation purposes; (2) the
negative declaration that there are no CTG or non-CTG major sources of
VOC and NOx emissions within the District of Columbia; and (3) no
revised or new, more stringent regulations that represent RACT control
levels, were adopted.  Therefore, approval of the District of
Columbia’s 8-hour RACT SIP is recommended.

IV.       Conclusion

This SIP revision request satisfies all requirements for an acceptable
SIP revision.

V.    Recommended Agency Action

The SIP revision request should be approved.

 PAGE

 PAGE   7


[Federal Register: February 9, 2006 (Volume 71, Number 27)]
[Notices]
[Page 6811]
[DOCID:fr09fe06-96]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53221; File No. SR-PCX-2005-102]

Self-Regulatory Organizations; Pacific Exchange, Inc.; Order
Granting Approval of Proposed Rule Change and Amendment No. 1 Thereto
Relating to the Elimination of Obsolete Rules Related to the Pacific
Options Exchange Trading System and Order Book Officials

February 3, 2006.
    On November 10, 2005, the Pacific Exchange, Inc. (``PCX'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to eliminate obsolete rules related to the Pacific
Options Exchange Trading System (``POETS'') and Order Book Officials
(``OBOs''). On November 22, 2005, PCX filed Amendment No. 1 to the
proposed rule change.\3\ The proposed rule change was published for
comment in the Federal Register on December 21, 2005.\4\ The Commission
received no comments on the proposal. This order approves the proposed
rule change, as amended.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Partial Amendment, submitted by Glenn H. Gsell, Director
of Regulation, PCX (``Amendment No. 1''). In Amendment No. 1, PCX
corrected a typographical error in the rule text.
    \4\ See Securities Exchange Act Release No. 52955 (December 14,
2005), 70 FR 75851 (December 21, 2005) (``Notice'').
---------------------------------------------------------------------------

    The proposed rule change, as amended, would modify the PCX Rules to
eliminate obsolete rules with respect to POETS and OBOs and make
corresponding changes to related rules. As of March 2005, the Exchange
completed its rollout of the PCX Plus System.\5\ As such, options
issues no longer trade on the POETS platform at the Exchange.
Therefore, the Exchange proposes to eliminate rules related to POETS,
including rules regarding OBOs, and to generally modify the rules as
applicable in the current PCX Plus market structure.\6\ In connection
with the proposed elimination of OBOs, the Exchange proposes to revise
the definition of ``Trading Official'' to no longer permit OTP Holders
to serve in this capacity and to clarify the responsibilities of
Trading Officials.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 47838 (May 13,
2003), 68 FR 27129 (May 19, 2003) (Order Approving Proposal for PCX
Plus).
    \6\ A full description of the rules that are being deleted or
modified pursuant to this proposal can be found in the Notice, supra
note 4.
---------------------------------------------------------------------------

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act \7\ and the rules and regulations
thereunder applicable to a national securities exchange,\8\
particularly Section 6(b)(5) of the Act,\9\ which requires, among other
things, that the Exchange's rules be designed to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system and to protect investors and the
public interest. The Commission believes that the proposed rule change
clarifies the Exchange's rules by eliminating provisions that no longer
are necessary in light of the obsolescence of POETS and the elimination
of the position of OBO. In addition, by requiring a Trading Official to
be an Exchange employee or officer, the proposed rule change is
designed to minimize potential conflicts of interest that otherwise may
arise when an OTP Holder is called upon to act in the capacity of a
Trading Official and to make a decision on a regulatory matter.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. 15 U.S.C. 78c(f).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\10\ that the proposed rule change (SR-PCX-2005-102), as amended,
is approved.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
 [FR Doc. E6-1778 Filed 2-8-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: December 12, 2006 (Volume 71, Number 238)]
[Notices]
[Page 74507]
[DOCID:fr12de06-73]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-93-000]

Texas Gas Transmission, LLC; Notice of Proposed Changes in FERC
Gas Tariff

December 5, 2006.
    Take notice that on November 30, 2006, Texas Gas Transmission, LLC
(Texas Gas) tendered for filing as part of its FERC Gas Tariff, Second
Revised Volume No. 1, Second Revised Sheet No. 36A, to become effective
January 1, 2007.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-21086 Filed 12-11-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 161 (Tuesday, August 20, 2013)]
[Notices]
[Pages 51201-51202]
[FR Doc No: 2013-20270]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4141-DR; Docket ID FEMA-2013-0001]

Wisconsin; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Wisconsin (FEMA-4141-DR), dated August 8,
2013, and related determinations.

DATES: Effective Date: August 8, 2013.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 8, 2013, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Wisconsin resulting from severe storms, flooding, and mudslides
during the period of June 20-28, 2013, is of sufficient severity and
magnitude to warrant a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (the ``Stafford Act''). Therefore, I declare that such
a major disaster exists in the State of Wisconsin.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to Section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Warren J. Riley, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Wisconsin have been designated
as adversely affected by this major disaster:

    Ashland, Bayfield, Crawford, Grant, Iowa, Richland, St. Croix,
and Vernon Counties and the Red Cliff Band of Lake Superior Chippewa
in Bayfield County for Public Assistance.
    All counties and Indian Tribes within the State of Wisconsin are
eligible to apply for assistance under the Hazard Mitigation Grant
Program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-20270 Filed 8-19-13; 8:45 am]
BILLING CODE 9111-23-P