Humanitarian Use Devices; 21st Century Cures Act; Technical Amendment, 26348-26349 [2017-11816]
Download as PDF
26348
Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Rules and Regulations
indigenous divinities, or rendering the
figures with Andean facial
characteristics or in traditional Andean
costume. In addition, each church,
convent, monastery, and town venerated
an effigy of its patron or tutelar saint,
some of them native to Peru.
pmangrum on DSK3GDR082PROD with RULES
Retables
Retables (retablos) are architectonic
structures made of stone, wood, or other
material that are placed behind the altar
and include attached paintings,
sculptures or other religious objects.
Liturgical Objects
Objects Used for Mass Ritual:
Chalices, cibaries, candelabras, vials for
christening or consecrated oil,
reliquaries, vessels for wine and water,
incense burners, patens, monstrances,
pelicans and crucifixes. Made out of
silver, gold or gilded silver, often inlaid
with pearls or precious stones.
Techniques: Casting, engraving,
´
piercing, repousse, filigree.
Fixtures for sculpted images: Areoles,
crowns, scepters, halo, halos in the form
of rays, and books carried by religious
scholars and founders of religious
orders.
Ecclesiastical vestments: Some
ecclesiastical vestments were
commissioned by indigenous
individuals or communities for the
celebrations of their patron saint and
thus are part of the religious legacy of
a particular town. In such cases, the
vestment has the name of the donor and
of the town or church as well as the
date.
Votive Offerings: These are
representations of miracles or favors
received from a particular saint. They
can be made of different materials,
usually metal or wood, and come in a
variety of forms according to the type of
favor received, usually representing
parts of the human body in reference to
the organ healed or agricultural
products in recognition of a good
harvest or increase in a herd.
C. Colonial Manuscripts and
Documents
Predominant materials: Paper,
parchment, vellum
Description: Original handwritten
texts or printed texts of limited
circulation dating to the Colonial period
(AD 1532–1821). These include but are
not limited to notary documents (wills,
bill of sales, contracts), ecclesiastical
materials, and documents of the city
councils, Governorate of New Castile,
the Governorate of New Toledo, the
Vice Royalty of Peru, the Real
Audiencia and Chancery of Lima, or the
Council of the Indies. These can include
books, single folios, or collections of
VerDate Sep<11>2014
15:10 Jun 06, 2017
Jkt 241001
related documents bound with string.
Documents may contain a seal or ink
stamp denoting a public or ecclesiastical
institution. Because many of these
documents are of institutional or official
nature, they may have multiple
signatures, denoting scribes, witnesses,
and other authorities. Documents are
generally written in Spanish, but may be
composed in an indigenous language
such as Quechua or Aymara.
The restrictions on the importation of
these archaeological and ethnological
materials from Peru are to continue in
effect through June 9, 2022. Importation
of such material continues to be
restricted unless the conditions set forth
in 19 U.S.C. 2606 and 19 CFR 12.104c
are met.
Inapplicability of Notice and Delayed
Effective Date
Sections 12.104 through 12.104i also
issued under 19 U.S.C. 2612;
*
*
*
§ 12.104g
*
*
[Amended]
2. In § 12.104g(a), the table of the list
of agreements imposing import
restrictions on described articles of
cultural property of State Parties is
amended in the entry for Peru by
removing the words ‘‘T.D. 97–50
extended by CBP Dec. 12–11’’ and
adding in their place ‘‘CBP Dec. 17–03’’
in the column headed ‘‘Decision No.’’.
■
Kevin K. McAleenan,
Acting Commissioner, U.S. Customs and
Border Protection.
Approved: June 2, 2017.
Timothy E. Skud,
Deputy Assistant Secretary of the Treasury.
[FR Doc. 2017–11841 Filed 6–6–17; 8:45 am]
This amendment involves a foreign
affairs function of the United States and
is, therefore, being made without notice
or public procedure (5 U.S.C. 553(a)(1)).
For the same reasons, pursuant to 5
U.S.C. 553(d)(3), a delayed effective date
is not required.
BILLING CODE 9111–14–P
Regulatory Flexibility Act
21 CFR Part 814
Because no notice of proposed
rulemaking is required, the provisions
of the Regulatory Flexibility Act (5
U.S.C. 601 et seq.) do not apply.
[Docket No. FDA–2017–N–0011]
Executive Order 12866
Because this rule involves a foreign
affairs function of the United States, it
is not subject to Executive Order 12866.
Signing Authority
This regulation is being issued in
accordance with 19 CFR 0.1(a)(1).
List of Subjects
Cultural property, Customs duties and
inspection, Imports, Prohibited
merchandise.
Amendment to CBP Regulations
For the reasons set forth above, part
12 of title 19 of the Code of Federal
Regulations (19 CFR part 12), is
amended as set forth below:
PART 12—SPECIAL CLASSES OF
MERCHANDISE
1. The general authority citation for
part 12 and the specific authority
citation for § 12.104g continue to read as
follows:
■
Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202
(General Note 3(i), Harmonized Tariff
Schedule of the United States (HTSUS)),
1624.
*
PO 00000
*
*
Frm 00014
*
Fmt 4700
*
Sfmt 4700
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Humanitarian Use Devices; 21st
Century Cures Act; Technical
Amendment
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending
regulations to reflect changes recently
enacted into law by the 21st Century
Cures Act. Specifically, certain
requirements related to humanitarian
device exemptions (HDEs) and
institutional review boards (IRBs) for
devices have changed. This action is
being taken to align the regulations with
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) as amended.
DATES: This rule is effective June 7,
2017.
SUMMARY:
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: On
December 13, 2016, the 21st Century
Cures Act (Pub. L. 114–255) was signed
into law, amending certain provisions of
the FD&C Act. FDA is updating
regulations to reflect some of those
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\07JNR1.SGM
07JNR1
pmangrum on DSK3GDR082PROD with RULES
Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Rules and Regulations
changes that are now in effect.
Specifically, section 3052 of the 21st
Century Cures Act amended section
520(m) of the FD&C Act to allow for
HDE approval for devices that, among
other things, treat or diagnose a disease
or condition that affects ‘‘not more than
8,000’’ individuals in the United States;
this threshold had been ‘‘fewer than
4,000’’ individuals in the United States
(amending 21 U.S.C. 360j(m), passim).
This final rule amends part 814 (21 CFR
part 814) in several places to accurately
reflect the threshold recently enacted
into law.
In addition, section 3056 of the 21st
Century Cures Act amended section 520
of the FD&C Act to remove the
requirement for institutional review
committees, i.e., IRBs, for devices to be
‘‘local’’, (amending 21 U.S.C. 360j,
passim). This final rule amends 21 CFR
814.124(a), ‘‘IRB approval’’, to remove
the term ‘‘local’’ and related language in
order to accurately reflect the
requirements recently enacted into law.
FDA finds good cause for issuing this
amendment as a final rule without
notice and comment because this
amendment only updates the
implementing regulation to restate the
statute in light of amendments recently
enacted into law (see 5 U.S.C. 553(b)(B),
relating to notice and comment
procedures): ‘‘[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-andcomment procedures are not required).
Therefore, we are issuing these
amendments as a final rule, and
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
these amendments 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 new requirements are already
effective as a matter of law.
Furthermore, this rule does not establish
additional regulatory obligations or
impose additional burden on regulated
entities. As a result, affected parties do
not need time to prepare before the rule
takes effect. Therefore, FDA finds good
VerDate Sep<11>2014
15:10 Jun 06, 2017
Jkt 241001
cause for these amendments to become
effective on the date of publication of
this action.
List of Subjects in 21 CFR Part 814
Administrative practice and
procedure, Confidential business
information, Medical devices, Medical
research, 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 part 814 is
amended as follows:
26349
cannot be obtained in time to prevent
serious harm or death to a patient, a
HUD may be administered without prior
approval by an IRB. In such an
emergency situation, the physician
shall, within 5 days after the use of the
device, provide written notification to
the chairman of the IRB of such use.
Such written notification shall include
the identification of the patient
involved, the date on which the device
was used, and the reason for the use.
*
*
*
*
*
§ 814.126
[Amended]
6. Amend § 814.126(b)(1)(iii) by
removing the number ‘‘4,000’’ and
adding in its place the number ‘‘8,000’’.
■
PART 814—PREMARKET APPROVAL
OF MEDICAL DEVICES
1. The authority citation for part 814
continues to read as follows:
Authority: 21 U.S.C. 351, 352, 353, 360,
360c–360j, 371, 372, 373, 374, 375, 379, 379e,
381.
§ 814.3
Dated: June 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–11816 Filed 6–6–17; 8:45 am]
BILLING CODE 4164–01–P
[Amended]
2. Amend § 814.3(n) by removing the
words ‘‘fewer than 4,000’’ and adding in
their place the words ‘‘not more than
8,000’’.
DEPARTMENT OF JUSTICE
§ 814.100
21 CFR Part 1308
■
[Amended]
3. Amend § 814.100(b) introductory
text by removing the words ‘‘fewer than
4,000’’ and adding in their place the
words ‘‘not more than 8,000’’.
■
§ 814.102
[Amended]
4. Amend § 814.102 as follows:
a. In paragraph (a)(5), remove the
words ‘‘fewer than 4,000’’ in both
occurrences and add in their places the
words ‘‘not more than 8,000’’ for both
occurrences;
■ b. In paragraph (b)(3)(i), remove the
words ‘‘fewer than 4,000’’ and add in
their place the words ‘‘not more than
8,000’’; and
■ c. In paragraph (b)(3)(ii), remove the
words ‘‘4,000 or more’’ and add in their
place the words ‘‘more than 8,000’’.
■ 5. In § 814.124, revise paragraph (a) to
read as follows:
■
■
§ 814.124 Institutional Review Board
requirements.
(a) IRB approval. The HDE holder is
responsible for ensuring that a HUD
approved under this subpart is
administered only in facilities having
oversight by an Institutional Review
Board (IRB) constituted and acting
pursuant to part 56 of this chapter,
including continuing review of use of
the device. In addition, a HUD may be
administered only if such use has been
approved by an IRB. If, however, a
physician in an emergency situation
determines that approval from an IRB
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
Drug Enforcement Administration
[Docket No. DEA–413]
Schedules of Controlled Substances:
Placement of Acetyl Fentanyl Into
Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
AGENCY:
With the issuance of this final
order, the Administrator of the Drug
Enforcement Administration will
maintain the placement of the substance
acetyl fentanyl (N-(1phenethylpiperidin-4-yl)-Nphenylacetamide), including its
isomers, esters, ethers, salts, and salts of
isomers, esters and ethers, in schedule
I of the Controlled Substances Act. This
scheduling action is pursuant to the
Controlled Substances Act and is
required in order for the United States
to discharge its obligations under the
Single Convention on Narcotic Drugs,
1961. This action continues to impose
the regulatory controls and
administrative, civil, and criminal
sanctions applicable to schedule I
controlled substances on persons who
handle (manufacture, distribute, import,
export, engage in research or conduct
instructional activities with, or possess),
or propose to handle, acetyl fentanyl.
DATES: Effective June 7, 2017.
FOR FURTHER INFORMATION CONTACT:
Michael J. Lewis, Diversion Control
SUMMARY:
E:\FR\FM\07JNR1.SGM
07JNR1
Agencies
[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Rules and Regulations]
[Pages 26348-26349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11816]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 814
[Docket No. FDA-2017-N-0011]
Humanitarian Use Devices; 21st Century Cures Act; Technical
Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending regulations
to reflect changes recently enacted into law by the 21st Century Cures
Act. Specifically, certain requirements related to humanitarian device
exemptions (HDEs) and institutional review boards (IRBs) for devices
have changed. This action is being taken to align the regulations with
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended.
DATES: This rule is effective June 7, 2017.
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: On December 13, 2016, the 21st Century Cures
Act (Pub. L. 114-255) was signed into law, amending certain provisions
of the FD&C Act. FDA is updating regulations to reflect some of those
[[Page 26349]]
changes that are now in effect. Specifically, section 3052 of the 21st
Century Cures Act amended section 520(m) of the FD&C Act to allow for
HDE approval for devices that, among other things, treat or diagnose a
disease or condition that affects ``not more than 8,000'' individuals
in the United States; this threshold had been ``fewer than 4,000''
individuals in the United States (amending 21 U.S.C. 360j(m), passim).
This final rule amends part 814 (21 CFR part 814) in several places to
accurately reflect the threshold recently enacted into law.
In addition, section 3056 of the 21st Century Cures Act amended
section 520 of the FD&C Act to remove the requirement for institutional
review committees, i.e., IRBs, for devices to be ``local'', (amending
21 U.S.C. 360j, passim). This final rule amends 21 CFR 814.124(a),
``IRB approval'', to remove the term ``local'' and related language in
order to accurately reflect the requirements recently enacted into law.
FDA finds good cause for issuing this amendment as a final rule
without notice and comment because this amendment only updates the
implementing regulation to restate the statute in light of amendments
recently enacted into law (see 5 U.S.C. 553(b)(B), relating to notice
and comment procedures): ``[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). Therefore, we are
issuing these amendments as a final rule, and 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 these amendments 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 new requirements are already effective as a matter of law.
Furthermore, this rule does not establish additional regulatory
obligations or impose additional burden on regulated entities. As a
result, affected parties do not need time to prepare before the rule
takes effect. Therefore, FDA finds good cause for these amendments to
become effective on the date of publication of this action.
List of Subjects in 21 CFR Part 814
Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, 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 part
814 is amended as follows:
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
1. The authority citation for part 814 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372,
373, 374, 375, 379, 379e, 381.
Sec. 814.3 [Amended]
0
2. Amend Sec. 814.3(n) by removing the words ``fewer than 4,000'' and
adding in their place the words ``not more than 8,000''.
Sec. 814.100 [Amended]
0
3. Amend Sec. 814.100(b) introductory text by removing the words
``fewer than 4,000'' and adding in their place the words ``not more
than 8,000''.
Sec. 814.102 [Amended]
0
4. Amend Sec. 814.102 as follows:
0
a. In paragraph (a)(5), remove the words ``fewer than 4,000'' in both
occurrences and add in their places the words ``not more than 8,000''
for both occurrences;
0
b. In paragraph (b)(3)(i), remove the words ``fewer than 4,000'' and
add in their place the words ``not more than 8,000''; and
0
c. In paragraph (b)(3)(ii), remove the words ``4,000 or more'' and add
in their place the words ``more than 8,000''.
0
5. In Sec. 814.124, revise paragraph (a) to read as follows:
Sec. 814.124 Institutional Review Board requirements.
(a) IRB approval. The HDE holder is responsible for ensuring that a
HUD approved under this subpart is administered only in facilities
having oversight by an Institutional Review Board (IRB) constituted and
acting pursuant to part 56 of this chapter, including continuing review
of use of the device. In addition, a HUD may be administered only if
such use has been approved by an IRB. If, however, a physician in an
emergency situation determines that approval from an IRB cannot be
obtained in time to prevent serious harm or death to a patient, a HUD
may be administered without prior approval by an IRB. In such an
emergency situation, the physician shall, within 5 days after the use
of the device, provide written notification to the chairman of the IRB
of such use. Such written notification shall include the identification
of the patient involved, the date on which the device was used, and the
reason for the use.
* * * * *
Sec. 814.126 [Amended]
0
6. Amend Sec. 814.126(b)(1)(iii) by removing the number ``4,000'' and
adding in its place the number ``8,000''.
Dated: June 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11816 Filed 6-6-17; 8:45 am]
BILLING CODE 4164-01-P