81 FR 11428 - Unique Device Identification System; Editorial Provisions; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 43 (March 4, 2016)

Page Range		11428-11429
FR Document		2016-04707

The Food and Drug Administration (FDA or Agency) is amending the Unique Device Identification (UDI) System regulation to make editorial changes. This technical amendment updates the email address associated with FDA's UDI system, which allows FDA to obtain information and offer support and assistance on medical devices through their distribution and use, ensuring consistency with the requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This change is necessary to ensure that the UDI team continues to maintain regular email communications with device labelers.

Federal Register, Volume 81 Issue 43 (Friday, March 4, 2016)

[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Rules and Regulations]
[Pages 11428-11429]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04707]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 801 and 830

[Docket No. FDA-2011-N-0090]


Unique Device Identification System; Editorial Provisions; 
Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is amending 
the Unique Device Identification (UDI) System regulation to make 
editorial changes. This technical amendment updates the email address 
associated with FDA's UDI system, which allows FDA to obtain 
information and offer support and assistance on medical devices through 
their distribution and use, ensuring consistency with the requirements 
in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This change 
is necessary to ensure that the UDI team continues to maintain regular 
email communications with device labelers.

DATES: This rule is effective March 4, 2016.

FOR FURTHER INFORMATION CONTACT: Adaeze Teme, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5574, Silver Spring, MD 20993-0002, 240-402-0768.

SUPPLEMENTARY INFORMATION: FDA is updating the UDI email address in the 
following regulations that set forth the procedures for notifying the 
Agency when: (1) Requesting an exception from or alternative to a 
unique device identifier requirement (Sec.  801.55 (21 CFR 801.55)); 
(2) requesting continued use of legacy FDA identification numbers 
assigned to devices (Sec.  801.57 (21 CFR 801.57)); and (3) applying 
for accreditation as an issuing Agency (Sec.  830.110 (21 CFR 
830.110)).
    Specifically, the Agency is removing an old email address and 
replacing it with a new one, thereby maintaining consistency with the 
requirements of the FD&C Act (21 U.S.C. 321 et seq.).
    In the Federal Register of September 24, 2013 (78 FR 58786), FDA 
issued a final rule to establish a system to adequately identify 
devices through distribution and use. The rule required the label of 
medical devices to include a UDI, except where an exception or 
alternative applies. The labeler must submit product information 
concerning devices to FDA's Global Unique Device Identification 
Database (GUDID). The final rule incorporated a direct avenue for the 
labeler to communicate with FDA's GUDID via a UDI email address. This 
rule updates Sec. Sec.  801.55(b)(2), 801.57(c)(2), and 830.110(a) by 
replacing the old email address with a new one.

List of Subjects

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping 
requirements.

21 CFR Part 830

    Administrative practice and procedure, Incorporation by reference, 
Labeling, Medical devices, 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 
801and 830 are amended as follows:

PART 801--LABELING

0
1. The authority citation for 21 CFR part 801 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.


0
2. In Sec.  801.55, revise paragraph (b)(2) to read as follows:


Sec.  801.55  Request for an exception from or alternative to a unique 
device identifier requirement.

* * * * *
    (b) * * *
    (2) In all other cases, by email to: [email protected], or 
by correspondence to: UDI Regulatory Policy Support, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002.
* * * * *

0
3. In Sec.  801.57, revise the second sentence of paragraph (c)(2) to 
read as follows:


Sec.  801.57  Discontinuation of legacy FDA identification numbers 
assigned to devices.

* * * * *
    (c) * * *
    (2) * * * * A request for continued use of an assigned labeler code 
must be submitted by email to: [email protected], or by 
correspondence to: UDI Regulatory Policy Support, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002.
* * * * *

[[Page 11429]]

PART 830--UNIQUE DEVICE IDENTIFICATION

0
4. The authority citation for 21 CFR part 830 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 
371.

0
5. In Sec.  830.110, revise paragraph (a)(1) to read as follows:


Sec.  830.110  Application for accreditation as an issuing agency.

    (a) * * * (1) An applicant seeking initial FDA accreditation as an 
issuing agency shall notify FDA of its desire to be accredited by 
sending a notification by email to: [email protected], or by 
correspondence to: UDI Regulatory Policy Support, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002.
* * * * *

    Dated: February 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04707 Filed 3-3-16; 8:45 am]
 BILLING CODE 4164-01-P

11428 Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Rules and Regulations

occur between points in the United DEPARTMENT OF HEALTH AND submit product information concerning
States, and between the United States HUMAN SERVICES devices to FDA’s Global Unique Device
and any foreign point, in the following Identification Database (GUDID). The
types of operations: Food and Drug Administration final rule incorporated a direct avenue
(i) Scheduled passenger foreign air for the labeler to communicate with
21 CFR Parts 801 and 830 FDA’s GUDID via a UDI email address.
transportation.
[Docket No. FDA–2011–N–0090] This rule updates §§ 801.55(b)(2),
(ii) Nonscheduled passenger foreign 801.57(c)(2), and 830.110(a) by
air transportation, if a flight attendant is Unique Device Identification System; replacing the old email address with a
a required crewmember on the aircraft Editorial Provisions; Technical new one.
as determined by the Administrator of Amendment List of Subjects
the Federal Aviation Administration or
a foreign carrier’s government. AGENCY: Food and Drug Administration, 21 CFR Part 801
HHS.
(2) Nothing in this section shall be Labeling, Medical devices, Reporting
Final rule; technical
ACTION:
deemed to require foreign air carriers to and recordkeeping requirements.
amendment.
permit smoking aboard aircraft. 21 CFR Part 830
(b) A foreign government objecting to SUMMARY: The Food and Drug
Administration (FDA or Agency) is Administrative practice and
the application of paragraph (a) of this procedure, Incorporation by reference,
section on the basis that paragraph (a) amending the Unique Device
Identification (UDI) System regulation Labeling, Medical devices, Reporting
provides for extraterritorial application and recordkeeping requirements.
of the laws of the United States may to make editorial changes. This
technical amendment updates the email Therefore, under the Federal Food,
request and obtain a waiver of Drug, and Cosmetic Act and under
paragraph (a) from the Assistant address associated with FDA’s UDI
system, which allows FDA to obtain authority delegated to the Commissioner
Secretary for Aviation and International of Food and Drugs, 21 CFR parts 801and
information and offer support and
Affairs, provided that an alternative 830 are amended as follows:
assistance on medical devices through
smoking prohibition resulting from
their distribution and use, ensuring
bilateral negotiations is in effect. consistency with the requirements in PART 801—LABELING
§ 252.7 [Removed] the Federal Food, Drug, and Cosmetic ■ 1. The authority citation for 21 CFR
Act (the FD&C Act). This change is part 801 continues to read as follows:
■ 7. Section 252.7 is removed. necessary to ensure that the UDI team
continues to maintain regular email Authority: 21 U.S.C. 321, 331, 351, 352,
■ 8. Section 252.8 is revised to read as 360i, 360j, 371, 374.
communications with device labelers.
follows:
DATES: This rule is effective March 4, ■ 2. In § 801.55, revise paragraph (b)(2)
§ 252.8 Extent of smoking restrictions. 2016. to read as follows:
The restrictions on smoking described FOR FURTHER INFORMATION CONTACT: § 801.55 Request for an exception from or
in §§ 252.4 and 252.5 shall apply to all Adaeze Teme, Center for Devices and alternative to a unique device identifier
locations within the aircraft. Radiological Health, Food and Drug requirement.
Administration, 10903 New Hampshire * * * * *
§§ 252.13 and 253.15 [Removed] Ave., Bldg. 66, Rm. 5574, Silver Spring, (b) * * *
MD 20993–0002, 240–402–0768. (2) In all other cases, by email to:
■ 9. Sections 252.13 and 253.15 are GUDIDSupport@fda.hhs.gov, or by
SUPPLEMENTARY INFORMATION: FDA is
removed. correspondence to: UDI Regulatory
updating the UDI email address in the
■ 10. Section 252.17 is revised to read following regulations that set forth the Policy Support, Center for Devices and
as follows: procedures for notifying the Agency Radiological Health, Food and Drug
when: (1) Requesting an exception from Administration, 10903 New Hampshire
§ 252.17 Enforcement. or alternative to a unique device Ave., Bldg. 66, Rm. 3303, Silver Spring,
identifier requirement (§ 801.55 (21 CFR MD 20993–0002.
Air carriers and foreign air carriers
shall take such action as is necessary to 801.55)); (2) requesting continued use of * * * * *
ensure that smoking by passengers or legacy FDA identification numbers ■ 3. In § 801.57, revise the second
crew is not permitted where smoking is assigned to devices (§ 801.57 (21 CFR sentence of paragraph (c)(2) to read as
801.57)); and (3) applying for follows:
prohibited by this part, including but
accreditation as an issuing Agency
not limited to aircraft lavatories. § 801.57 Discontinuation of legacy FDA
(§ 830.110 (21 CFR 830.110)).
Specifically, the Agency is removing identification numbers assigned to devices.
§ 252.19 [Removed]
an old email address and replacing it * * * * *
■ 11. Section 252.19 is removed. with a new one, thereby maintaining (c) * * *
[FR Doc. 2016–04799 Filed 3–3–16; 8:45 am] consistency with the requirements of (2) * * * * A request for continued
the FD&C Act (21 U.S.C. 321 et seq.). use of an assigned labeler code must be
BILLING CODE 4910–9X–P
In the Federal Register of September submitted by email to: GUDIDSupport@
jstallworth on DSK7TPTVN1PROD with RULES

24, 2013 (78 FR 58786), FDA issued a fda.hhs.gov, or by correspondence to:
final rule to establish a system to UDI Regulatory Policy Support, Center
adequately identify devices through for Devices and Radiological Health,
distribution and use. The rule required Food and Drug Administration, 10903
the label of medical devices to include New Hampshire Ave., Bldg. 66, Rm.
a UDI, except where an exception or 3303, Silver Spring, MD 20993–0002.
alternative applies. The labeler must * * * * *

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Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Rules and Regulations 11429

PART 830—UNIQUE DEVICE pyrrolidinobutiophenone (a-PBP) current list of all scheduled substances
IDENTIFICATION [hereinafter 4–MEC, 4-MePPP, a-PVP, is published at 21 CFR part 1308.
butylone, pentedrone, pentylone, 4– Section 201 of the CSA (21 U.S.C.
■ 4. The authority citation for 21 CFR FMC, 3–FMC, naphyrone, and a-PBP, 811) provides the Attorney General with
part 830 continues to read as follows: respectively], including their optical, the authority to temporarily place a
Authority: 21 U.S.C. 321, 331, 352, 353, positional, and geometric isomers, salts, substance into schedule I of the CSA for
360, 360d, 360i, 360j, 371. and salts of isomers. The current final two years without regard to the
■ 5. In § 830.110, revise paragraph (a)(1) order temporarily placing 4–MEC, 4- requirements of 21 U.S.C. 811(b) if she
to read as follows: MePPP, a-PVP, butylone, pentedrone, finds that such action is necessary to
pentylone, 4–FMC, 3–FMC, naphyrone, avoid an imminent hazard to the public
§ 830.110 Application for accreditation as and a-PBP into schedule I is in effect safety. 21 U.S.C. 811(h)(1). In addition,
an issuing agency. through March 6, 2016. This final order if proceedings to control a substance are
(a) * * * (1) An applicant seeking will extend the temporary scheduling of initiated under 21 U.S.C. 811(a)(1), the
initial FDA accreditation as an issuing 4–MEC, 4-MePPP, a-PVP, butylone, Attorney General may extend the
agency shall notify FDA of its desire to pentedrone, pentylone, 4–FMC, 3–FMC, temporary scheduling for up to one
be accredited by sending a notification naphyrone, and a-PBP for one year, or year. 21 U.S.C. 811(h)(2).
by email to: GUDIDSupport@ until the permanent scheduling action Where the necessary findings are
fda.hhs.gov, or by correspondence to: for these 10 substances is completed, made, a substance may be temporarily
UDI Regulatory Policy Support, Center whichever occurs first. scheduled if it is not listed in any other
for Devices and Radiological Health, schedule under section 202 of the CSA
DATES: This final order is effective
Food and Drug Administration, 10903 (21 U.S.C. 812) or if there is no
March 4, 2016.
New Hampshire Ave., Bldg. 66, Rm. exemption or approval in effect for the
FOR FURTHER INFORMATION CONTACT: substance under section 505 of the
3303, Silver Spring, MD 20993–0002.
Barbara J. Boockholdt, Office of Federal Food, Drug, and Cosmetic Act
* * * * * Diversion Control, Drug Enforcement (FDCA), 21 U.S.C. 355. 21 U.S.C.
Dated: February 29, 2016. Administration; Mailing Address: 8701 811(h)(1). The Attorney General has
Leslie Kux, Morrissette Drive, Springfield, Virginia delegated her scheduling authority
Associate Commissioner for Policy. 22152; Telephone: (202) 598–6812. under 21 U.S.C. 811 to the
[FR Doc. 2016–04707 Filed 3–3–16; 8:45 am] SUPPLEMENTARY INFORMATION: Administrator of the DEA. 28 CFR
BILLING CODE 4164–01–P Legal Authority 0.100.
The Drug Enforcement Background
Administration (DEA) implements and On March 7, 2014, the DEA published
DEPARTMENT OF JUSTICE
enforces titles II and III of the a final order in the Federal Register
Drug Enforcement Administration Comprehensive Drug Abuse Prevention amending 21 CFR 1308.11(h) to
and Control Act of 1970, as amended. temporarily place the 10 synthetic
21 CFR Part 1308 Titles II and III are referred to as the cathinones 4-methyl-N-ethylcathinone
‘‘Controlled Substances Act’’ and the (4–MEC); 4-methyl-alpha-
[Docket No. DEA–386] ‘‘Controlled Substances Import and pyrrolidinopropiophenone (4-MePPP);
Export Act,’’ respectively, and are alpha-pyrrolidinopentiophenone (a-
Schedules of Controlled Substances: collectively referred to as the PVP); 1-(1,3-benzodioxol-5-yl)-2-
Extension of Temporary Placement of ‘‘Controlled Substances Act’’ or the (methylamino)butan-1-one (butylone);
10 Synthetic Cathinones in Schedule I ‘‘CSA’’ for purpose of this action. 21 2-(methylamino)-1-phenylpentan-1-one
of the Controlled Substances Act U.S.C. 801–971. The DEA published the (pentedrone); 1-(1,3-benzodioxol-5-yl)-
AGENCY: Drug Enforcement implementing regulations for these 2-(methylamino)pentan-1-one
Administration, Department of Justice. statutes in title 21 of the Code of Federal (pentylone); 4-fluoro-N-
ACTION: Final order. Regulations (CFR), chapter II. methylcathinone (4–FMC); 3-fluoro-N-
The CSA and its implementing methylcathinone (3–FMC); 1-
SUMMARY: The Administrator of the Drug regulations are designed to prevent, (naphthalen-2-yl)-2-(pyrrolidin-1-
Enforcement Administration is issuing detect, and eliminate the diversion of yl)pentan-1-one (naphyrone); and alpha-
this final order to extend the temporary controlled substances and listed pyrrolidinobutiophenone (a-PBP) into
schedule I status of 10 synthetic chemicals into the illicit market while schedule I of the CSA pursuant to the
cathinones pursuant to the temporary ensuring an adequate supply is available temporary scheduling provisions of 21
scheduling provisions of the Controlled for the legitimate medical, scientific, U.S.C. 811(h). 79 FR 12938. That final
Substances Act. The 10 substances are: research, and industrial needs of the order was effective on the date of
4-methyl-N-ethylcathinone (4–MEC); 4- United States. Controlled substances publication, and was based on findings
methyl-alpha- have the potential for abuse and by the Deputy Administrator of the DEA
pyrrolidinopropiophenone (4-MePPP); dependence and are controlled to that the temporary scheduling of these
alpha-pyrrolidinopentiophenone (a- protect the public health and safety. ten synthetic cathinones was necessary
PVP); 1-(1,3-benzodioxol-5-yl)-2- Under the CSA, every controlled to avoid an imminent hazard to the
(methylamino)butan-1-one (butylone); substance is classified into one of five public safety pursuant to 21 U.S.C.
2-(methylamino)-1-phenylpentan-1-one schedules based upon its potential for 811(h)(1). Section 201(h)(2) of the CSA
jstallworth on DSK7TPTVN1PROD with RULES

(pentedrone); 1-(1,3-benzodioxol-5-yl)- abuse, its currently accepted medical (21 U.S.C. 811(h)(2)) requires that the
2-(methylamino)pentan-1-one use in treatment in the United States, temporary control of these substances
(pentylone); 4-fluoro-N- and the degree of dependence the drug expires two years from the effective date
methylcathinone (4–FMC); 3-fluoro-N- or other substance may cause. 21 U.S.C. of the scheduling order, or on March 6,
methylcathinone (3–FMC); 1- 812. The initial schedules of controlled 2016. However, the CSA also provides
(naphthalen-2-yl)-2-(pyrrolidin-1- substances established by Congress are that during the pendency of proceedings
yl)pentan-1-one (naphyrone); and alpha- found at 21 U.S.C. 812(c), and the under 21 U.S.C. 811(a)(1) with respect

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Document Created: 2018-02-02 15:05:46
Document Modified: 2018-02-02 15:05:46

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 March 4, 2016.
Contact		Adaeze Teme, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5574, Silver Spring, MD 20993-0002, 240-402-0768.
FR Citation		81 FR 11428
CFR Citation		21 CFR 801 21 CFR 830
CFR Associated		Labeling; Medical Devices; Reporting and Recordkeeping Requirements; Administrative Practice and Procedure and Incorporation by Reference

81 FR 11428 - Unique Device Identification System; Editorial Provisions; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 43 (March 4, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration