Office of Regulatory Affairs Division Director; Technical Amendments
| Published date | 24 March 2020 |
| Citation | 85 FR 16549 |
| Record Number | 2020-05213 |
| Section | Rules and Regulations |
| Court | Food And Drug Administration |
Federal Register, Volume 85 Issue 57 (Tuesday, March 24, 2020)
[Federal Register Volume 85, Number 57 (Tuesday, March 24, 2020)]
[Rules and Regulations]
[Pages 16549-16555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, 240-402-4557.
SUPPLEMENTARY INFORMATION:
[[Page 16550]]
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:
[[Page 16551]]
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
[[Page 16552]]
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
[[Page 16553]]
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
* * * * *
[[Page 16554]]
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.
* * * * *
[[Page 16555]]
(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
