Document ID: FDA-2016-N-0011-0003
Agency: fda
Document Type: Rule
Title: Regulatory Hearing Before the Food and Drug Administration; General Provisions; Technical Amendment
Posted Date: 2016-08-11T04:00Z

[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)]
[Rules and Regulations]
[Pages 52994-52995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18787]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 16

[Docket No. FDA-2016-N-0011]

Regulatory Hearing Before the Food and Drug Administration; 
General Provisions; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to correct an error in the lists of statutory and 
regulatory provisions that provide an opportunity for an informal 
hearing so that the lists correctly reference the statutory and 
regulatory provisions that provide such an opportunity in connection 
with a ban of a device. This action is being taken to align the 
regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) and avoid any potential confusion the erroneous lists may cause.

DATES: This rule is effective August 11, 2016.

FOR FURTHER INFORMATION CONTACT: Ian Ostermiller, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5515, Silver Spring, MD 20993-0002, 301-
796-5678.

SUPPLEMENTARY INFORMATION: FDA is correcting an error in the 
regulations that identify the statutory and regulatory provisions that 
provide an opportunity for a regulatory hearing, also known as an 
informal hearing (Sec.  16.1 (21 CFR 16.1)). In the list of statutory 
provisions at Sec.  16.1(b)(1), the Agency is adding a reference to 
subsection (b) of section 516 of the FD&C Act (21 U.S.C. 360f), which 
provides for a reasonable opportunity for an informal hearing when FDA 
proposes a medical device ban with a special effective date (21 U.S.C. 
360f(b)(2)). The list of statutory provisions does not currently 
specify subsection (b) of section 516 of the FD&C Act, and it 
incorrectly refers to 21 CFR 895.21(d). An opportunity for a hearing is 
not required under section 516 of the FD&C Act or part 895 (21 CFR part 
895) for bans that do not have a special effective date.
    Further, the list of regulatory provisions at Sec.  16.1(b)(2) does 
not include any reference to part 895. We are correcting this by adding 
a reference to Sec.  895.30(c), which provides for an opportunity for 
an informal hearing under 21 CFR part 16 when FDA proposes a medical 
device ban with a special effective date. These corrections will align 
Sec.  16.1(b) with section 516 of the FD&C Act and part 895 to avoid 
confusion regarding when an opportunity for hearing is required for a 
device ban.
    Prior to the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-
629), the FD&C Act required the Secretary of Health and Human Services 
to afford an opportunity for informal hearings about any proposed rule 
to ban a medical device, regardless of effective date. One of the 
SMDA's provisions removed the requirement that FDA provide an 
opportunity for an informal hearing when FDA does not establish a 
special

[[Page 52995]]

effective date for a proposed ban.\1\ However, the SMDA did not 
eliminate the informal hearing provision for a proposed ban issued with 
a special effective date. Thus, section 516(b) of the FD&C Act 
continues to require that FDA ``provide reasonable opportunity for an 
informal hearing'' on a proposed ban with a special effective date (21 
U.S.C. 360f(b)) while subsection (a), the general rule for medical 
device bans, does not (see 21 U.S.C. 360f(a)).
---------------------------------------------------------------------------

    \1\ Specifically, the SMDA deleted the then-last sentence of 
section 516(a). See Public Law 101-629, section 18(d)(2) (``Section 
516(a) (21 U.S.C. 360f(a)) is amended . . . by striking out the last 
sentence.''); 21 U.S.C. 360f(a) (1989) (stating, in the last 
sentence, ``The Secretary shall afford all interested persons 
opportunity for an informal hearing on a regulation proposed under 
this subsection.'').
---------------------------------------------------------------------------

    On December 10, 1992 (57 FR 58400), FDA published a final rule 
implementing the SMDA. The final rule of 1992 amended Sec.  895.21(d), 
which covers the procedures for issuing a ban without a special 
effective date, by removing the requirement that FDA provide an 
opportunity for an informal hearing when there is no special effective 
date.\2\ FDA incorrectly removed the same language from Sec.  895.30, 
which covers the procedures for issuing bans with special effective 
dates; the Agency issued a technical amendment restoring this language 
in the Federal Register of June 2, 2015 (80 FR 31299). However, FDA did 
not correct the language in Sec.  16.1 to list section 516(b) of the 
FD&C Act and Sec.  895.30(c) as the provisions that provide for 
regulatory (informal) hearings, nor did the Agency remove the reference 
to Sec.  895.21(d). FDA does so now.
---------------------------------------------------------------------------

    \2\ Although the hearing provision was validly removed from 
Sec.  895.21(d)(8) in 1992, the removed language erroneously 
reappeared in the Code of Federal Regulations beginning in 1994. On 
March 5, 2015 (80 FR 11865), the Office of the Federal Register 
published a correction document fixing this publication error.
---------------------------------------------------------------------------

    FDA finds good cause for issuing this amendment to Sec.  16.1(b)(1) 
as a final rule without notice and comment because this amendment 
corrects the regulations to restate the statute (5 U.S.C. 553(b)(B)). 
``[W]hen regulations merely restate the statute they implement, notice-
and-comment procedures are unnecessary.'' Gray Panthers Advocacy 
Committee v. Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. 1991); see also 
Komjathy v. Nat. Trans. Safety Bd., 832 F.2d 1294, 1296 (D.C. Cir. 
1987) (when a rule ``does no more than repeat, virtually verbatim, the 
statutory grant of authority,'' notice-and-comment procedures are not 
required). Further, the change to remove the erroneous cross-reference 
to Sec.  895.21(d) and add the correct cross-reference toSec.  
895.30(c) is merely technical, insignificant in nature and impact, and 
inconsequential to industry and the public. See Mack Trucks, Inc. v. 
EPA, 682 F.3d 87, 94 (D.C. Cir. 2012). This is because this correction 
in no way changes when FDA is required to provide an opportunity for a 
hearing, which is determined by section 516 of the FD&C Act and part 
895, nor does it impact the availability of such a hearing to any 
entity impacted by the proposed ban. It merely corrects a citation 
error to avoid confusion. This amendment to Sec.  16.1(b) thus merely 
corrects the references to the applicable requirements of the FD&C Act 
and its implementing regulations, making notice-and-comment procedures 
unnecessary in this case. Therefore, publication of this document 
constitutes final action on this change under the Administrative 
Procedure Act (APA) (5 U.S.C. 553).
    In addition, FDA finds good cause for this amendment to become 
effective on the date of publication of this action. 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 amendment to Sec.  16.1 does 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 this correction to become effective on the date of 
publication of this action.

List of Subjects in 21 CFR Part 16

    Administrative practice and procedure.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
16 is amended as follows:

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

0
1. The authority citation for part 16 continues to read as follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
2. Amend Sec.  16.1 as follows:
0
a. In paragraph (b)(1), remove from the list the entry ``Section 516 of 
the act relating to a proposed banned device regulations (see Sec.  
895.21(d) of this chapter).'' and add in its place ``Section 516(b) of 
the act regarding a proposed regulation to ban a medical device with a 
special effective date.''
0
b. In paragraph (b)(2), add an entry in numerical sequence for ``Sec.  
895.30(c), regarding a proposed regulation to ban a medical device with 
a special effective date.''

    Dated: August 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18787 Filed 8-10-16; 8:45 am]
 BILLING CODE 4164-01-P