81 FR 52994 - Regulatory Hearing Before the Food and Drug Administration; General Provisions; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 155 (August 11, 2016)

Page Range		52994-52995
FR Document		2016-18787

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.

Federal Register, Volume 81 Issue 155 (Thursday, August 11, 2016)

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


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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.

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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)).
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    \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.'').
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    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.
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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 beginning 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 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

52994 Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Rules and Regulations

Lists of Subjects in 14 CFR Part 71 (Lat. 46° 00′34″ N., long. 83° 44′38″ W.) regulations to correct an error in the
Airspace, Incorporation by reference, That airspace extending upward from 700 lists of statutory and regulatory
feet above the surface within a 6.5-mile provisions that provide an opportunity
Navigation (air).
radius of Drummond Island Airport, and for an informal hearing so that the lists
Adoption of the Amendment within 4 miles each side of the 072° bearing correctly reference the statutory and
from the airport extending from the 6.5-mile regulatory provisions that provide such
In consideration of the foregoing, the radius to 8.5 miles east of the airport; that
Federal Aviation Administration an opportunity in connection with a ban
airspace extending upward from 1,200 feet
amends 14 CFR part 71 as follows: above the surface bounded by long. 83° of a device. This action is being taken
57’00’’ W., on the west; long. 83° 26’00’’ W., to align the regulations with the Federal
PART 71—DESIGNATION OF CLASS A, on the east; lat. 46° 05’00’’ N., on the north; Food, Drug, and Cosmetic Act (the
B, C, D, AND E AIRSPACE AREAS; AIR and lat. 45° 45’00’’ N., on the south, FD&C Act) and avoid any potential
TRAFFIC SERVICE ROUTES; AND excluding that airspace within Canada. confusion the erroneous lists may cause.
REPORTING POINTS * * * * * DATES: This rule is effective August 11,
2016.
■ 1. The authority citation for part 71 AGL MI E5 Gladwin, MI [Amended]
FOR FURTHER INFORMATION CONTACT: Ian
continues to read as follows: Charles C. Zettel Memorial Airport, MI
Ostermiller, Center for Devices and
Authority: 49 U.S.C. 106(f), 106(g); 40103, (Lat. 43°58′14″ N., long. 84°28′30″ W.)
Radiological Health, Food and Drug
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, That airspace extending upward from 700 Administration, 10903 New Hampshire
1959–1963 Comp., p. 389. feet above the surface within a 6.5-mile
radius of the Charles C. Zettel Memorial
Ave., Bldg. 66, Rm. 5515, Silver Spring,
§ 71.1 [Amended] Airport. MD 20993–0002, 301–796–5678.
■ 2. The incorporation by reference in * * * * * SUPPLEMENTARY INFORMATION: FDA is
14 CFR 71.1 of FAA Order 7400.9Z, correcting an error in the regulations
AGL MI E5 Holland, MI [Amended] that identify the statutory and regulatory
Airspace Designations and Reporting
West Michigan Regional Airport, MI provisions that provide an opportunity
Points, dated August 6, 2015, and
(Lat. 42°44′34″ N., long. 86°06′28″ W.) for a regulatory hearing, also known as
effective September 15, 2015, is
That airspace extending upward from 700 an informal hearing (§ 16.1 (21 CFR
amended as follows:
feet above the surface within a 6.5-mile 16.1)). In the list of statutory provisions
radius of the West Michigan Regional at § 16.1(b)(1), the Agency is adding a
Paragraph 6005 Class E Airspace Areas
Airport.
Extending Upward From 700 Feet or More reference to subsection (b) of section
Above the Surface of the Earth. * * * * * 516 of the FD&C Act (21 U.S.C. 360f),
* * * * * AGL MI E5 Three Rivers, MI [Amended] which provides for a reasonable
AGL MI E5 Alma, MI [Amended] Three Rivers Municipal Dr Haines Airport, opportunity for an informal hearing
MI when FDA proposes a medical device
Alma, Gratiot Community Airport, MI ban with a special effective date (21
(Lat. 43°19′20″ N., long. 84°41′17″ W.) (Lat. 41°57′35″ N., long. 85°35′35″ W.)
Mount Pleasant VOR/DME That airspace extending upward from 700 U.S.C. 360f(b)(2)). The list of statutory
(Lat. 43°37′22″ N., long. 84°44′14″ W.) feet above the surface within a 6.4-mile provisions does not currently specify
That airspace extending upward from 700 radius of Three Rivers Municipal Dr Haines subsection (b) of section 516 of the
feet above the surface within a 6.5-mile Airport, excluding that airspace within the FD&C Act, and it incorrectly refers to 21
radius of Gratiot Community Airport, and Sturgis, Kirsch Municipal Airport, MI, Class CFR 895.21(d). An opportunity for a
within 2.0 miles either side of a 270° bearing E airspace area. hearing is not required under section
from the airport extending from the 6.5-mile Issued in Fort Worth, Texas, on July 29, 516 of the FD&C Act or part 895 (21 CFR
radius to 10.1 miles west of the airport, and 2016. part 895) for bans that do not have a
within 1.5 miles either side of the Mount Walter Tweedy, special effective date.
Pleasant VOR/DME 178° radial extending Further, the list of regulatory
from the 6.5-mile radius to 10.3 miles north Acting Manager, Operations Support Group,
ATO Central Service Center. provisions at § 16.1(b)(2) does not
of the airport.
[FR Doc. 2016–18777 Filed 8–10–16; 8:45 am] include any reference to part 895. We
* * * * * are correcting this by adding a reference
BILLING CODE 4910–13–P
AGL MI E5 Bellaire, MI [Amended] to § 895.30(c), which provides for an
Bellaire, Antrim County Airport, MI opportunity for an informal hearing
(Lat. 44°59′19″ N., long. 85°11′54″ W.) DEPARTMENT OF HEALTH AND under 21 CFR part 16 when FDA
That airspace extending upward from 700 HUMAN SERVICES proposes a medical device ban with a
feet above the surface within a 6.5-mile special effective date. These corrections
radius of Antrim County Airport, and within Food and Drug Administration will align § 16.1(b) with section 516 of
1.9 miles each side of the 197° bearing from the FD&C Act and part 895 to avoid
the airport extending from the 6.5-mile confusion regarding when an
21 CFR Part 16
radius to 6.9 miles south of the airport. opportunity for hearing is required for a
* * * * * [Docket No. FDA–2016–N–0011] device ban.
AGL MI E5 Cadillac, MI [Amended] Prior to the Safe Medical Devices Act
Regulatory Hearing Before the Food
of 1990 (SMDA) (Pub. L. 101–629), the
Cadillac, Wexford County Airport, MI and Drug Administration; General
(Lat. 44°16′31″ N., long. 85°25′08″ W.)
FD&C Act required the Secretary of
Provisions; Technical Amendment
Health and Human Services to afford an
That airspace extending upward from 700
sradovich on DSK3GMQ082PROD with RULES

feet above the surface within a 6.7-mile AGENCY: Food and Drug Administration, opportunity for informal hearings about
radius of the Wexford County Airport. HHS. any proposed rule to ban a medical
Final rule; technical
ACTION: device, regardless of effective date. One
* * * * *
amendment. of the SMDA’s provisions removed the
AGL MI E5 Drummond Island, MI requirement that FDA provide an
[Amended] SUMMARY: The Food and Drug opportunity for an informal hearing
Drummond Island Airport, MI Administration (FDA) is amending its when FDA does not establish a special

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Document Created: 2018-02-09 11:27:36
Document Modified: 2018-02-09 11:27:36

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule; technical amendment.
Dates		This rule is effective August 11, 2016.
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.
FR Citation		81 FR 52994

81 FR 52994 - Regulatory Hearing Before the Food and Drug Administration; General Provisions; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 155 (August 11, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration