82 FR 26348 - Humanitarian Use Devices; 21st Century Cures Act; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 108 (June 7, 2017)

Page Range		26348-26349
FR Document		2017-11816

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.

Federal Register, Volume 82 Issue 108 (Wednesday, June 7, 2017)

[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Rules and Regulations]
[Pages 26348-26349]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-11816]


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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

26348 Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Rules and Regulations

indigenous divinities, or rendering the related documents bound with string. Sections 12.104 through 12.104i also
figures with Andean facial Documents may contain a seal or ink issued under 19 U.S.C. 2612;
characteristics or in traditional Andean stamp denoting a public or ecclesiastical * * * * *
costume. In addition, each church, institution. Because many of these
convent, monastery, and town venerated documents are of institutional or official § 12.104g [Amended]
an effigy of its patron or tutelar saint, nature, they may have multiple ■ 2. In § 12.104g(a), the table of the list
some of them native to Peru. signatures, denoting scribes, witnesses, of agreements imposing import
and other authorities. Documents are restrictions on described articles of
Retables
generally written in Spanish, but may be cultural property of State Parties is
Retables (retablos) are architectonic composed in an indigenous language amended in the entry for Peru by
structures made of stone, wood, or other such as Quechua or Aymara. removing the words ‘‘T.D. 97–50
material that are placed behind the altar The restrictions on the importation of extended by CBP Dec. 12–11’’ and
and include attached paintings, these archaeological and ethnological adding in their place ‘‘CBP Dec. 17–03’’
sculptures or other religious objects. materials from Peru are to continue in in the column headed ‘‘Decision No.’’.
Liturgical Objects effect through June 9, 2022. Importation Kevin K. McAleenan,
of such material continues to be Acting Commissioner, U.S. Customs and
Objects Used for Mass Ritual:
restricted unless the conditions set forth Border Protection.
Chalices, cibaries, candelabras, vials for
in 19 U.S.C. 2606 and 19 CFR 12.104c Approved: June 2, 2017.
christening or consecrated oil,
are met.
reliquaries, vessels for wine and water, Timothy E. Skud,
incense burners, patens, monstrances, Inapplicability of Notice and Delayed Deputy Assistant Secretary of the Treasury.
pelicans and crucifixes. Made out of Effective Date [FR Doc. 2017–11841 Filed 6–6–17; 8:45 am]
silver, gold or gilded silver, often inlaid
This amendment involves a foreign BILLING CODE 9111–14–P
with pearls or precious stones.
affairs function of the United States and
Techniques: Casting, engraving,
is, therefore, being made without notice
piercing, repoussé, filigree. DEPARTMENT OF HEALTH AND
Fixtures for sculpted images: Areoles, or public procedure (5 U.S.C. 553(a)(1)).
For the same reasons, pursuant to 5 HUMAN SERVICES
crowns, scepters, halo, halos in the form
of rays, and books carried by religious U.S.C. 553(d)(3), a delayed effective date
is not required. Food and Drug Administration
scholars and founders of religious
orders. Regulatory Flexibility Act 21 CFR Part 814
Ecclesiastical vestments: Some
ecclesiastical vestments were Because no notice of proposed [Docket No. FDA–2017–N–0011]
commissioned by indigenous rulemaking is required, the provisions
individuals or communities for the of the Regulatory Flexibility Act (5 Humanitarian Use Devices; 21st
celebrations of their patron saint and U.S.C. 601 et seq.) do not apply. Century Cures Act; Technical
thus are part of the religious legacy of Amendment
Executive Order 12866
a particular town. In such cases, the AGENCY: Food and Drug Administration,
vestment has the name of the donor and Because this rule involves a foreign HHS.
of the town or church as well as the affairs function of the United States, it
is not subject to Executive Order 12866. Final rule; technical
ACTION:
date. amendment.
Votive Offerings: These are Signing Authority
representations of miracles or favors SUMMARY: The Food and Drug
received from a particular saint. They This regulation is being issued in Administration (FDA) is amending
can be made of different materials, accordance with 19 CFR 0.1(a)(1). regulations to reflect changes recently
usually metal or wood, and come in a List of Subjects enacted into law by the 21st Century
variety of forms according to the type of Cures Act. Specifically, certain
favor received, usually representing Cultural property, Customs duties and requirements related to humanitarian
parts of the human body in reference to inspection, Imports, Prohibited device exemptions (HDEs) and
the organ healed or agricultural merchandise. institutional review boards (IRBs) for
products in recognition of a good Amendment to CBP Regulations devices have changed. This action is
harvest or increase in a herd. being taken to align the regulations with
C. Colonial Manuscripts and For the reasons set forth above, part the Federal Food, Drug, and Cosmetic
Documents 12 of title 19 of the Code of Federal Act (the FD&C Act) as amended.
Predominant materials: Paper, Regulations (19 CFR part 12), is DATES: This rule is effective June 7,
parchment, vellum amended as set forth below: 2017.
Description: Original handwritten
texts or printed texts of limited PART 12—SPECIAL CLASSES OF FOR FURTHER INFORMATION CONTACT: Ian
circulation dating to the Colonial period MERCHANDISE Ostermiller, Center for Devices and
(AD 1532–1821). These include but are Radiological Health, Food and Drug
not limited to notary documents (wills, ■ 1. The general authority citation for Administration, 10903 New Hampshire
bill of sales, contracts), ecclesiastical part 12 and the specific authority Ave., Bldg. 66, Rm. 5515, Silver Spring,
pmangrum on DSK3GDR082PROD with RULES

materials, and documents of the city citation for § 12.104g continue to read as MD 20993–0002, 301 796–5678.
councils, Governorate of New Castile, follows: SUPPLEMENTARY INFORMATION: On
the Governorate of New Toledo, the Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 December 13, 2016, the 21st Century
Vice Royalty of Peru, the Real (General Note 3(i), Harmonized Tariff Cures Act (Pub. L. 114–255) was signed
Audiencia and Chancery of Lima, or the Schedule of the United States (HTSUS)), into law, amending certain provisions of
Council of the Indies. These can include 1624. the FD&C Act. FDA is updating
books, single folios, or collections of * * * * * regulations to reflect some of those

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Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Rules and Regulations 26349

changes that are now in effect. cause for these amendments to become cannot be obtained in time to prevent
Specifically, section 3052 of the 21st effective on the date of publication of serious harm or death to a patient, a
Century Cures Act amended section this action. HUD may be administered without prior
520(m) of the FD&C Act to allow for approval by an IRB. In such an
List of Subjects in 21 CFR Part 814
HDE approval for devices that, among emergency situation, the physician
other things, treat or diagnose a disease Administrative practice and shall, within 5 days after the use of the
or condition that affects ‘‘not more than procedure, Confidential business device, provide written notification to
8,000’’ individuals in the United States; information, Medical devices, Medical the chairman of the IRB of such use.
this threshold had been ‘‘fewer than research, Reporting and recordkeeping Such written notification shall include
4,000’’ individuals in the United States requirements. the identification of the patient
(amending 21 U.S.C. 360j(m), passim). Therefore, under the Federal Food, involved, the date on which the device
This final rule amends part 814 (21 CFR Drug, and Cosmetic Act and under was used, and the reason for the use.
part 814) in several places to accurately authority delegated to the Commissioner * * * * *
reflect the threshold recently enacted of Food and Drugs, 21 CFR part 814 is
into law. amended as follows: § 814.126 [Amended]
In addition, section 3056 of the 21st ■ 6. Amend § 814.126(b)(1)(iii) by
Century Cures Act amended section 520 PART 814—PREMARKET APPROVAL removing the number ‘‘4,000’’ and
of the FD&C Act to remove the OF MEDICAL DEVICES adding in its place the number ‘‘8,000’’.
requirement for institutional review
committees, i.e., IRBs, for devices to be 1. The authority citation for part 814 Dated: June 1, 2017.
‘‘local’’, (amending 21 U.S.C. 360j, continues to read as follows: Anna K. Abram,
passim). This final rule amends 21 CFR Authority: 21 U.S.C. 351, 352, 353, 360, Deputy Commissioner for Policy, Planning,
814.124(a), ‘‘IRB approval’’, to remove 360c–360j, 371, 372, 373, 374, 375, 379, 379e, Legislation, and Analysis.
the term ‘‘local’’ and related language in 381. [FR Doc. 2017–11816 Filed 6–6–17; 8:45 am]
order to accurately reflect the § 814.3 [Amended]
BILLING CODE 4164–01–P
requirements recently enacted into law.
FDA finds good cause for issuing this ■ 2. Amend § 814.3(n) by removing the
amendment as a final rule without words ‘‘fewer than 4,000’’ and adding in DEPARTMENT OF JUSTICE
notice and comment because this their place the words ‘‘not more than
amendment only updates the 8,000’’. Drug Enforcement Administration
implementing regulation to restate the
§ 814.100 [Amended] 21 CFR Part 1308
statute in light of amendments recently
enacted into law (see 5 U.S.C. 553(b)(B), ■ 3. Amend § 814.100(b) introductory [Docket No. DEA–413]
relating to notice and comment text by removing the words ‘‘fewer than
procedures): ‘‘[W]hen regulations 4,000’’ and adding in their place the Schedules of Controlled Substances:
merely restate the statute they words ‘‘not more than 8,000’’. Placement of Acetyl Fentanyl Into
implement, notice-and-comment Schedule I
§ 814.102 [Amended]
procedures are unnecessary’’. Gray
Panthers Advocacy Committee v. ■ 4. Amend § 814.102 as follows: AGENCY: Drug Enforcement
Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. ■ a. In paragraph (a)(5), remove the Administration, Department of Justice.
1991); see also Komjathy v. Nat. Trans. words ‘‘fewer than 4,000’’ in both ACTION: Final order.
Safety Bd., 832 F.2d 1294, 1296 (D.C. occurrences and add in their places the
words ‘‘not more than 8,000’’ for both SUMMARY: With the issuance of this final
Cir. 1987) (when a rule ‘‘does no more
occurrences; order, the Administrator of the Drug
than repeat, virtually verbatim, the
■ b. In paragraph (b)(3)(i), remove the
Enforcement Administration will
statutory grant of authority’’, notice-and-
comment procedures are not required). words ‘‘fewer than 4,000’’ and add in maintain the placement of the substance
Therefore, we are issuing these their place the words ‘‘not more than acetyl fentanyl (N-(1-
amendments as a final rule, and 8,000’’; and phenethylpiperidin-4-yl)-N-
publication of this document constitutes ■ c. In paragraph (b)(3)(ii), remove the
phenylacetamide), including its
final action on this change under the words ‘‘4,000 or more’’ and add in their isomers, esters, ethers, salts, and salts of
Administrative Procedure Act (APA) (5 place the words ‘‘more than 8,000’’. isomers, esters and ethers, in schedule
U.S.C. 553). I of the Controlled Substances Act. This
■ 5. In § 814.124, revise paragraph (a) to
In addition, FDA finds good cause for scheduling action is pursuant to the
read as follows: Controlled Substances Act and is
these amendments to become effective
on the date of publication of this action. § 814.124 Institutional Review Board required in order for the United States
The APA allows an effective date less requirements. to discharge its obligations under the
than 30 days after publication as (a) IRB approval. The HDE holder is Single Convention on Narcotic Drugs,
‘‘provided by the agency for good cause responsible for ensuring that a HUD 1961. This action continues to impose
found and published with the rule’’ (5 approved under this subpart is the regulatory controls and
U.S.C. 553(d)(3)). A delayed effective administered only in facilities having administrative, civil, and criminal
date is unnecessary in this case because oversight by an Institutional Review sanctions applicable to schedule I
the new requirements are already Board (IRB) constituted and acting controlled substances on persons who
pmangrum on DSK3GDR082PROD with RULES

effective as a matter of law. pursuant to part 56 of this chapter, handle (manufacture, distribute, import,
Furthermore, this rule does not establish including continuing review of use of export, engage in research or conduct
additional regulatory obligations or the device. In addition, a HUD may be instructional activities with, or possess),
impose additional burden on regulated administered only if such use has been or propose to handle, acetyl fentanyl.
entities. As a result, affected parties do approved by an IRB. If, however, a DATES: Effective June 7, 2017.
not need time to prepare before the rule physician in an emergency situation FOR FURTHER INFORMATION CONTACT:
takes effect. Therefore, FDA finds good determines that approval from an IRB Michael J. Lewis, Diversion Control

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Document Created: 2017-06-07 02:01:07
Document Modified: 2017-06-07 02:01:07

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 June 7, 2017.
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		82 FR 26348
CFR Associated		Administrative Practice and Procedure; Confidential Business Information; Medical Devices; Medical Research and Reporting and Recordkeeping Requirements

82 FR 26348 - Humanitarian Use Devices; 21st Century Cures Act; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 108 (June 7, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration