[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Rules and Regulations]
[Pages 14143-14147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05350]


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

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-2017-N-0011]


Presiding Officer for an Appeal and Informal Hearing; Technical 
Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
making revisions to Chapter I of its regulations. These revisions are 
necessary to reflect changes to the Agency's organizational structure, 
including the dissolution of the Regional Food and Drug Director 
position. The revisions replace references to the Regional Food and 
Drug Director, who is designated to preside over administrative appeals 
and at informal hearings on appeal, with references to Office of 
Regulatory Affairs Program Directors. 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 17, 2017.

FOR FURTHER INFORMATION CONTACT: Peter Fox, Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, 
MD 20852, 240-402-1857.

SUPPLEMENTARY INFORMATION: 

[[Page 14144]]

I. Background

    The FDA Office of Regulatory Affairs has dissolved the Regional 
Food and Drug Director position. Certain duties related to 
administrative appeals and informal hearings formerly held by Regional 
Food and Drug Directors will transfer to Office of Regulatory Affairs 
Program Directors. The revisions made by this rule pertain solely to 
the designation of FDA officials and do not alter any substantive 
standards.

II. Description of the Technical Amendments

    The regulations specified in this rule have been revised to replace 
all references to the ``Regional Food and Drug Director'' with ``Office 
of Regulatory Affairs Program Director,'' to reflect the change in 
designation. In addition, the regulations have been revised to 
authorize other FDA officials senior to an FDA District Director to 
perform duties related to administrative appeals and informal hearings. 
Finally, we have made minor conforming amendments and grammatical 
changes as necessary to accommodate the new language.
    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. The rule does not impose any new 
regulatory requirements on affected parties. The amendments are 
editorial in nature and should not be construed as modifying any 
substantive standards or requirements.

III. Notice and Public Comment

    Publication of this document constitutes final action of these 
changes under the Administrative Procedure Act (5 U.S.C. 553). Section 
553 of the Administrative Procedure Act (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 make technical or 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 
any new regulatory 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, 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.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
1, 101, 112, 115, 117, 118, 507, and 800 are amended as follows:

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.  1.403 by revising paragraph (f) to read as follows:


Sec.  1.403  What requirements apply to an informal hearing?

* * * * *
    (f) Section 1.404, rather than Sec.  16.42(a) of this chapter, 
describes the FDA employees, i.e., Office of Regulatory Affairs Program 
Directors or other officials senior to a District Director, who preside 
at hearings under this subpart;
* * * * *

0
3. 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 District Director.

0
4. Amend Sec.  1.980 by revising paragraphs (g)(3)(iv) and (g)(4) to 
read as follows:


Sec.  1.980  Administrative detention of drugs.

* * * * *
    (g) * * *
    (3) * * *
    (iv) Paragraph (g)(4) of this section, rather than Sec.  16.42(a) 
of this chapter, describes the FDA employees, i.e., Office of 
Regulatory Affairs Program Directors or other FDA officials senior to 
an FDA District Director, 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 District Director who is permitted by Sec.  16.42(a) of this 
chapter to preside over the hearing.
* * * * *

PART 101--FOOD LABELING

0
5. 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
6. Amend Sec.  101.17 by revising paragraphs (h)(7)(ii) introductory 
text, (h)(7)(ii)(B), (h)(7)(ii)(C) introductory text, (h)(7)(ii)(C)(1), 
(h)(7)(ii)(C)(4), (h)(7)(ii)(C)(5), (h)(7)(ii)(C)(6), (h)(7)(ii)(D), 
(h)(7)(ii)(E), and (h)(7)(ii)(F) to read as follows:

[[Page 14145]]

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

* * * * *
    (h) * * *
    (7) * * *
    (ii) The person on whom the order for relabeling, diversion, or 
destruction is served may either comply with the order or appeal the 
order to an Office of Regulatory Affairs Program Director.
* * * * *
    (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 District 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 District Director, 
and a written summary of the proceedings shall be prepared by the 
presiding FDA official.
    (1) The presiding FDA official may direct that the hearing be 
conducted in any suitable manner permitted by law and this section. The 
presiding FDA official has the power to take such actions and make such 
rulings as are necessary or appropriate to maintain order and to 
conduct an informal, fair, expeditious, and impartial hearing, and to 
enforce the requirements concerning the conduct of hearings.
* * * * *
    (4) The party requesting the hearing may have the hearing 
transcribed, at the party's expense, in which case a copy of the 
transcript is to be furnished to FDA. Any transcript of the hearing 
will be included with the presiding FDA official's report of the 
hearing.
    (5) The presiding FDA official shall prepare a written report of 
the hearing. All written material presented at the hearing will be 
attached to the report. Whenever time permits, the presiding FDA 
official may give the parties the opportunity to review and comment on 
the report of the hearing.
    (6) The presiding FDA official shall include as part of the report 
of the hearing a finding on the credibility of witnesses (other than 
expert witnesses) whenever credibility is a material issue, and shall 
include a recommended decision, with a statement of reasons.
    (D) Written appeal. If the appellant appeals the detention order 
but does not request a hearing, the presiding FDA official shall render 
a decision on the appeal affirming or revoking the detention within 5-
working days after the receipt of the appeal.
    (E) Presiding FDA official's decision. If, based on the evidence 
presented at the hearing or by the appellant in a written appeal, the 
presiding FDA official finds that the shell eggs were held in violation 
of this section, he shall affirm the order that they be relabeled, 
diverted under the supervision of an officer or employee of FDA for 
processing under the EPIA, or destroyed by or under the supervision of 
an officer or employee of FDA; otherwise, the presiding FDA official 
shall issue a written notice that the prior order is withdrawn. If the 
presiding FDA official affirms the order, he shall order that the 
relabeling, diversion, or destruction be accomplished within 10-working 
days from the date of the issuance of his decision. The presiding FDA 
official's decision shall be accompanied by a statement of the reasons 
for the decision. The decision of the presiding FDA official shall 
constitute final agency action, reviewable in the courts.
    (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 district 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
7. 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
8. 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 District Director.

PART 115--SHELL EGGS

0
9. 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
10. Amend Sec.  115.50 by revising paragraphs (e)(2) introductory text, 
(e)(2)(ii), (e)(2)(iii) introductory text, (e)(2)(iii)(A), 
(e)(2)(iii)(D), (e)(2)(iii)(E), (e)(2)(iii)(F), (e)(2)(iv), (e)(2)(v), 
and (e)(2)(vi) to read as follows:


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

* * * * *
    (e) * * *
    (2) The person on whom the order for diversion or destruction is 
served may either comply with the order or appeal the order to an 
Office of Regulatory Affairs Program Director in accordance with the 
following procedures:
* * * * *
    (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 District 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 District Director, 
and a written summary of the proceedings shall be prepared by the 
presiding FDA official.
    (A) The presiding FDA official may direct that the hearing be 
conducted in any suitable manner permitted by law and this section. The 
presiding FDA official has the power to take such actions and make such 
rulings as are necessary or appropriate to maintain order and to 
conduct an informal, fair, expeditious, and impartial hearing, and to 
enforce the requirements concerning the conduct of hearings.
* * * * *
    (D) The party requesting the hearing may have the hearing 
transcribed, at the party's expense, in which case a copy of

[[Page 14146]]

the transcript is to be furnished to FDA. Any transcript of the hearing 
will be included with the presiding FDA official's report of the 
hearing.
    (E) The presiding FDA official shall prepare a written report of 
the hearing. All written material presented at the hearing will be 
attached to the report. Whenever time permits, the presiding FDA 
official may give the parties the opportunity to review and comment on 
the report of the hearing.
    (F) The presiding FDA official shall include as part of the report 
of the hearing a finding on the credibility of witnesses (other than 
expert witnesses) whenever credibility is a material issue, and shall 
include a recommended decision, with a statement of reasons.
    (iv) Written appeal. If the appellant appeals the detention order 
but does not request a hearing, the presiding FDA official shall render 
a decision on the appeal affirming or revoking the detention within 5-
working days after the receipt of the appeal.
    (v) Presiding FDA official's decision. If, based on the evidence 
presented at the hearing or by the appellant in a written appeal, the 
presiding FDA official finds that the shell eggs were held in violation 
of this section, he shall affirm the order that they be diverted, under 
the supervision of an officer or employee of FDA for processing under 
the EPIA or destroyed by or under the supervision of an officer or 
employee of FDA; otherwise, the presiding FDA official shall issue a 
written notice that the prior order is withdrawn. If the presiding FDA 
official affirms the order, he shall order that the diversion or 
destruction be accomplished within 10-working days from the date of the 
issuance of his decision. The presiding FDA official's decision shall 
be accompanied by a statement of the reasons for the decision. The 
decision of the presiding FDA official shall constitute final agency 
action, reviewable in the courts.
    (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 district 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
11. 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
12. 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 District Director.

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

    13. 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
14. Amend Sec.  118.12 by revising paragraphs (a)(1)(i) introductory 
text, (a)(2) introductory text, (a)(2)(ii), (a)(2)(iii) introductory 
text, (a)(2)(iii)(A), (a)(2)(iii)(D), (a)(2)(iii)(E), (a)(2)(iii)(F), 
(a)(2)(v), and (a)(2)(vi) to read as follows:


Sec.  118.12  Enforcement and compliance.

* * * * *
    (a) * * *
    (1) * * *
    (i) Order for diversion or destruction under the PHS Act. Any 
district 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 regulation, 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-long 
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 District Director under 
paragraph (a)(2)(v) of this section. The order must include the 
following information:
* * * * *
    (2) The person on whom the order for diversion or destruction is 
served may either comply with the order or appeal the order to an 
Office of Regulatory Affairs Program Director in accordance with the 
following procedures:
* * * * *
    (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 District 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 District Director, 
and a written summary of the proceedings must be prepared by the 
presiding FDA official.
    (A) The presiding FDA official may direct that the hearing be 
conducted in any suitable manner permitted by law and by this section. 
The presiding FDA official has the power to take such actions and make 
such rulings as are necessary or appropriate to maintain order and to 
conduct an informal, fair, expeditious, and impartial hearing, and to 
enforce the requirements concerning the conduct of hearings.
* * * * *
    (D) The party requesting the hearing may have the hearing 
transcribed, at the party's expense, in which case a copy of the 
transcript is to be furnished to FDA. Any transcript of the hearing 
will be included with the presiding FDA official's report of the 
hearing.
    (E) The presiding FDA official must prepare a written report of the 
hearing. All written material presented at the hearing will be attached 
to the report. Whenever time permits, the presiding FDA official may 
give the parties the opportunity to review and comment on the report of 
the hearing.
    (F) The presiding FDA official must include as part of the report 
of the hearing a finding on the credibility of witnesses (other than 
expert witnesses) whenever credibility is a material issue,

[[Page 14147]]

and must include a recommended decision, with a statement of reasons.
    (iv) Written appeal. If the appellant appeals the detention order 
but does not request a hearing, the presiding FDA official must render 
a decision on the appeal affirming or revoking the detention order 
within 5-working days after the receipt of the appeal.
    (v) Presiding FDA official's decision. If, based on the evidence 
presented at the hearing or by the appellant in a written appeal, the 
presiding FDA official finds that the shell eggs were produced or held 
in violation of this section, he must affirm the order that they be 
diverted, under the supervision of an officer or employee of FDA for 
processing under the EPIA or by a treatment that achieves at least a 5-
log destruction of SE or destroyed by or under the supervision of an 
officer or employee of FDA; otherwise, the presiding FDA official must 
issue a written notice that the prior order is withdrawn. If the 
presiding FDA official affirms the order, he must order that the 
diversion or destruction be accomplished within 10-working days from 
the date of the issuance of his decision. The presiding FDA official's 
decision must be accompanied by a statement of the reasons for the 
decision. The decision of the presiding FDA official constitutes final 
agency action, subject to judicial review.
    (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 district 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
15. 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
16. Revise Sec.  507.75 to read as follows:


Sec.  507.75  Residing 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 District Director.

PART 800--GENERAL

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

    Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k, 
361, 362, 371.

0
18. Amend Sec.  800.55 by revising paragraphs (g)(3)(iv) and (g)(4) to 
read as follows:


Sec.  800.55  Administrative detention.

* * * * *
    (g) * * *
    (3) * * *
    (iv) Paragraph (g)(4) of this section, rather than Sec.  16.42(a) 
of this chapter, describes the FDA employees, i.e., Office of 
Regulatory Affairs Program Directors or other FDA officials senior to 
an FDA District Director, 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 District Director who is permitted by Sec.  16.42(a) of this 
chapter to preside over the hearing.
* * * * *

    Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05350 Filed 3-16-17; 8:45 am]
 BILLING CODE 4164-01-P