[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