Document ID: FDA-2015-N-0011-0002
Agency: fda
Document Type: Rule
Title: Banned Devices; General Provisions; Technical Amendments
Posted Date: 2015-06-02T04:00Z

[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Rules and Regulations]
[Pages 31299-31300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13329]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 895

[Docket No. FDA-2015-N-0011]

Banned Devices; General Provisions; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to clarify that the Agency will provide an opportunity for 
an informal hearing in connection with a proposed rule to ban a device 
with a special effective date. This action is being taken to align the 
regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act).

DATES: This rule is effective June 2, 2015.

FOR FURTHER INFORMATION CONTACT: Ian Ostermiller, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4432, Silver Spring, MD 20993-0002, 301-
796-5678.

SUPPLEMENTARY INFORMATION: FDA is correcting an error in the 
regulations that set forth the procedures for banning a medical device 
using a special effective date (Sec.  895.30 (21 CFR 895.30)). 
Specifically, the Agency is restoring a phrase that was incorrectly 
deleted from Sec.  895.30(c). The regulations are being amended to 
ensure clarity and consistency with the requirements of the FD&C Act 
(21 U.S.C. 321 et seq.).
    In this case, the regulations became inconsistent after the Safe 
Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629) amended the FD&C 
Act. Prior to the SMDA, 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 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)).
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    \1\ Specifically, the SMDA deleted the then-last sentence of 
section 516(a). See Pub. L. 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.'').
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    On December 10, 1992 (57 FR 58400), FDA published a final rule 
implementing the SMDA. The final rule of 1992 correctly amended 21 CFR 
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\ However, the final rule incorrectly removed the same phrase 
from Sec.  895.30,

[[Page 31300]]

which covers the procedures for issuing a ban with a special effective 
date. This rule corrects Sec.  895.30(c) by restoring the incorrectly 
removed phrase.
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    \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 starting in 1994. On 
March 5, 2015 (80 FR 11865), the Office of the Federal Register 
published a correction document fixing this publication error.
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    FDA finds good cause for issuing this amendment as a final rule 
without notice and comment because this amendment only corrects the 
implementing regulation 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). This amendment to Sec.  895.30(c) merely incorporates 
applicable requirements of the FD&C Act, 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.  895.30 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 895

    Administrative practice and procedure, Labeling, Medical devices.

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

PART 895--BANNED DEVICES

0
1. The authority citation for 21 CFR part 895 continues to read as 
follows:

    Authority:  21 U.S.C. 352, 360f, 360h, 360i, 371.

0
2. Amend Sec.  895.30 by revising paragraph (c) to read as follows:

Sec.  895.30  Special effective date.

* * * * *
    (c) If the Commissioner makes a proposed regulation effective in 
accordance with this section, the Commissioner will, as expeditiously 
as possible, give interested persons prompt notice of this action in 
the Federal Register and will provide an opportunity for an informal 
hearing in accordance with part 16 of this chapter.
* * * * *

    Dated: May 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13329 Filed 6-1-15; 8:45 am]
 BILLING CODE 4164-01-P