Document ID: FDA-2019-N-0011-0001
Agency: fda
Document Type: Rule
Title: Office of Regulatory Affairs Division Director; Technical Amendments
Posted Date: 2020-03-24T04:00Z

[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