82 FR 60304 - Addition of Certain Entities to the Entity List
DEPARTMENT OF COMMERCE
Bureau of Industry and Security Federal Register Volume 82, Issue 243 (December 20, 2017)
Bureau of Industry and Security
Federal Register Volume 82, Issue 243 (December 20, 2017)
| Page Range | 60304-60306 | |
| FR Document | 2017-27388 |
[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)] [Rules and Regulations] [Pages 60304-60306] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27388] [[Page 60304]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Part 744 [Docket No. 140908761-7999-02] RIN 0694--AG29 Addition of Certain Entities to the Entity List AGENCY: Bureau of Industry and Security, Commerce. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This rule amends the Export Administration Regulations (EAR) by adding two entities to the Entity List. The two entities being added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. These two entities will be listed on the Entity List under the destination of Russia. DATES: This rule is effective December 20, 2017. FOR FURTHER INFORMATION CONTACT: Chair, End-User Review Committee, Office of the Assistant Secretary, Export Administration, Bureau of Industry and Security, Department of Commerce, Phone: (202) 482-5991, Email: [email protected]. SUPPLEMENTARY INFORMATION: Background The Entity List (Supplement No. 4 to part 744 of the Export Administration Regulations (EAR)) identifies entities and other persons reasonably believed to be involved, or to pose a significant risk of being or becoming involved, in activities contrary to the national security or foreign policy interests of the United States. The EAR imposes additional license requirements on, and limits the availability of most license exceptions for, exports, reexports, and transfers (in- country) to those listed. The ``license review policy'' for each listed entity or other person is identified in the License Review Policy column on the Entity List and the impact on the availability of license exceptions is described in the Federal Register document adding entities or other persons to the Entity List. BIS places entities and other persons on the Entity List pursuant to sections of part 744 (Control Policy: End-User and End-Use Based) and part 746 (Embargoes and Other Special Controls) of the EAR. The End-User Review Committee (ERC), composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy and, where appropriate, the Treasury, makes all decisions regarding additions to, removals from, or other modifications to the Entity List. The ERC makes decisions to add an entry to the Entity List by majority vote and decisions to remove or modify an entry by unanimous vote. The Departments represented on the ERC have approved these changes to the Entity List. ERC Entity List Decisions Additions to the Entity List This rule implements the decision of the ERC to add two entities to the Entity List. These two entities are being added on the basis of Sec. 744.11 (License requirements that apply to entities acting contrary to the national security or foreign policy interests of the United States) of the EAR. The two entries added to the Entity List consist of two entities located in Russia. Under Sec. 744.11(b) (Criteria for revising the Entity List) of the EAR, persons for whom there is reasonable cause to believe, based on specific and articulable facts, that they have been involved, are involved, or pose a significant risk of being or becoming involved in, activities that are contrary to the national security or foreign policy interests of the United States and those acting on behalf of such persons may be added to the Entity List. Paragraphs (b)(1) through (b)(5) of Sec. 744.11 provide an illustrative list of activities that could be contrary to the national security or foreign policy interests of the United States. BIS, pursuant to Section 744.11(b) of the EAR, and in consultation with the Departments of State, Defense, Energy and the Treasury, has designated the two persons, located in the Russian Federation, to be added to the Entity List for actions contrary to the national security or foreign policy interests of the United States. Specifically, these entities produced, for the Russian Federation Ministry of Defense, a ground-launched cruise missile system, and associated transporter- erector-launcher, with a range prohibited by the Intermediate-Range Nuclear Forces Treaty. Both the Russian Federation and the United States are party to the INF Treaty. Therefore, there is reasonable cause to believe, based on specific and articulable facts, that Joint Stock Company Experimental Design Bureau Novator, and Joint Stock Company Federal Scientific and Production Center Titan-Barrikady have been involved in actions contrary to the national security or foreign policy interests of the United States. The prior review of exports, reexports or transfers (in-country) of all items subject to the EAR involving these persons, and the possible imposition of license conditions or license denials on shipments to the persons, will enhance BIS's ability to prevent use of items subject to the EAR contrary to U.S. national security or foreign policy interests. For the two persons added to the Entity List, BIS imposes a license requirement for all items subject to the EAR, and a license review policy of presumption of denial. The license requirements apply to any transaction in which items are to be exported, reexported, or transferred (in-country) to either of the persons or in which such persons act as purchaser, intermediate consignee, ultimate consignee, or end-user. In addition, no license exceptions are available for exports, reexports, or transfers (in-country) to the persons being added to the Entity List in this rule. The acronym ``a.k.a.'' (also known as) is used in entries on the Entity List to identify aliases and help exporters, reexporters and transferors to better identify persons on the Entity List. This final rule adds the following two entities to the Entity List: Russia (1) Joint Stock Company Experimental Design Bureau Novator, a.k.a., the following two aliases: --Novator Design Bureau; and --JSC OKB Novator. 18 Prospekt Kosmonavtov, 620017 Yekaterinburg, Russia; and (2) Joint Stock Company Federal Scientific and Production Center Titan-Barrikady, a.k.a., the following three aliases: --Federal Research and Production Center Titan Barrikady JSC; --Titan Design Bureau; and --JSC FNPTS Titan-Barrikady. Prospekt Imeni V.I. Lenina, b/n 400071, Volgograd, Russia. Export Administration Act of 1979 Although the Export Administration Act of 1979 expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 15, 2017, 82 FR 39005 (August 16, 2017), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act of 1979, as appropriate and to the extent permitted by law, pursuant to Executive Order [[Page 60305]] 13222, as amended by Executive Order 13637. Rulemaking Requirements 1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866. This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866. 2. Notwithstanding any other provision of law, no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by OMB under control number 0694-0088, Simplified Network Application Processing System, which includes, among other things, license applications, and carries a burden estimate of 43.8 minutes for a manual or electronic submission. Total burden hours associated with the PRA and OMB control number 0694-0088 are not expected to increase as a result of this rule. You may send comments regarding the collection of information associated with this rule, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget (OMB), by email to [email protected], or by fax to (202) 395-7285. 3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132. 4. For the two persons added to the Entity List in this final rule, the provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation and a 30-day delay in effective date are inapplicable because this regulation involves a military or foreign affairs function of the United States (5 U.S.C. 553(a)(1)). BIS implementation of this rule is necessary to protect U.S. national security or foreign policy interests by preventing items from being exported, reexported, or transferred (in-country) to the persons being added to the Entity List. If this rule were delayed to allow for notice and comment and a delay in effective date, the entities being added to the Entity List by this action would continue to be able to receive items without a license and to conduct activities contrary to the national security or foreign policy interests of the United States. In addition, publishing a proposed rule would give these parties notice of the U.S. Government's intention to place them on the Entity List, which could create an incentive for these persons to accelerate receiving items subject to the EAR to conduct activities that are contrary to the national security or foreign policy interests of the United States, including taking steps to set up additional aliases, change addresses, and other measures to try to limit the impact of the listing on the Entity List once a final rule is published. Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are not applicable. Accordingly, no regulatory flexibility analysis is required and none has been prepared. List of Subjects in 15 CFR Part 744 Exports, Reporting and recordkeeping requirements, Terrorism. Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows: PART 744--[AMENDED] 0 1. The authority citation for part 744 is revised to read as follows: Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; Notice of January 13, 2017, 82 FR 6165 (January 18, 2017); Notice of August 15, 2017, 82 FR 39005 (August 16, 2017); Notice of September 18, 2017, 82 FR 43825 (September 19, 2017); Notice of November 6, 2017, 82 FR 51971 (November 8, 2017). 0 2. Supplement No. 4 to part 744 is amended by adding under Russia, two Russian entities. The additions read as follows: Supplement No. 4 to Part 744--Entity List * * * * * ---------------------------------------------------------------------------------------------------------------- License review Federal Register Country Entity License requirement policy citation ---------------------------------------------------------------------------------------------------------------- * * * * * * * ---------------------------------------------------------------------------------------------------------------- RUSSIA................. * * * * * * ---------------------------------------------------------------------------------------- Joint Stock Company For all items Presumption of 82 FR [INSERT FR Experimental Design Bureau subject to the denial. PAGE NUMBER], Novator, a.k.a., the EAR. (See Sec. December 12/20/ following two aliases: 744.11 of the 17. --Novator Design Bureau; and EAR). --JSC OKB Novator. 18 Prospekt Kosmonavtov, 620017 Yekaterinburg, Russia. [[Page 60306]] Joint Stock Company Federal For all items Presumption of 82 FR [INSERT FR Scientific and Production subject to the denial. PAGE NUMBER], 12/ Center Titan-Barrikady, EAR. (See Sec. 20/17. a.k.a., the following three 744.11 of the aliases: EAR). --Federal Research and Production Center Titan Barrikady JSC; --Titan Design Bureau; and --JSC FNPTS Titan-Barrikady. Prospekt Imeni V.I. Lenina, b/n 400071, Volgograd, Russia. ---------------------------------------------------------------------------------------------------------------- * * * * * * * ---------------------------------------------------------------------------------------------------------------- Dated: December 15, 2017. Richard E. Ashooh, Assistant Secretary for Export Administration. [FR Doc. 2017-27388 Filed 12-19-17; 8:45 am] BILLING CODE 3510-33-P
![60304 Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Rules and Regulations
DEPARTMENT OF COMMERCE decisions regarding additions to, subject to the EAR involving these
removals from, or other modifications to persons, and the possible imposition of
Bureau of Industry and Security the Entity List. The ERC makes license conditions or license denials on
decisions to add an entry to the Entity shipments to the persons, will enhance
15 CFR Part 744 List by majority vote and decisions to BIS’s ability to prevent use of items
[Docket No. 140908761–7999–02] remove or modify an entry by subject to the EAR contrary to U.S.
unanimous vote. The Departments national security or foreign policy
RIN 0694—AG29 represented on the ERC have approved interests.
these changes to the Entity List. For the two persons added to the
Addition of Certain Entities to the Entity List, BIS imposes a license
Entity List ERC Entity List Decisions
requirement for all items subject to the
AGENCY: Bureau of Industry and Additions to the Entity List EAR, and a license review policy of
Security, Commerce. This rule implements the decision of presumption of denial. The license
ACTION: Final rule. the ERC to add two entities to the Entity requirements apply to any transaction in
List. These two entities are being added which items are to be exported,
SUMMARY: This rule amends the Export reexported, or transferred (in-country) to
on the basis of § 744.11 (License
Administration Regulations (EAR) by either of the persons or in which such
requirements that apply to entities
adding two entities to the Entity List. persons act as purchaser, intermediate
acting contrary to the national security
The two entities being added to the consignee, ultimate consignee, or end-
or foreign policy interests of the United
Entity List have been determined by the user. In addition, no license exceptions
States) of the EAR. The two entries
U.S. Government to be acting contrary are available for exports, reexports, or
added to the Entity List consist of two
to the national security or foreign policy transfers (in-country) to the persons
entities located in Russia.
interests of the United States. These two Under § 744.11(b) (Criteria for being added to the Entity List in this
entities will be listed on the Entity List revising the Entity List) of the EAR, rule. The acronym ‘‘a.k.a.’’ (also known
under the destination of Russia. persons for whom there is reasonable as) is used in entries on the Entity List
DATES: This rule is effective December cause to believe, based on specific and to identify aliases and help exporters,
20, 2017. articulable facts, that they have been reexporters and transferors to better
FOR FURTHER INFORMATION CONTACT: involved, are involved, or pose a identify persons on the Entity List.
Chair, End-User Review Committee, significant risk of being or becoming This final rule adds the following two
Office of the Assistant Secretary, Export involved in, activities that are contrary entities to the Entity List:
Administration, Bureau of Industry and to the national security or foreign policy Russia
Security, Department of Commerce, interests of the United States and those
Phone: (202) 482–5991, Email: ERC@ (1) Joint Stock Company Experimental
acting on behalf of such persons may be
bis.doc.gov. Design Bureau Novator, a.k.a., the
added to the Entity List. Paragraphs
following two aliases:
SUPPLEMENTARY INFORMATION: (b)(1) through (b)(5) of § 744.11 provide
an illustrative list of activities that could —Novator Design Bureau; and
Background be contrary to the national security or —JSC OKB Novator.
The Entity List (Supplement No. 4 to foreign policy interests of the United 18 Prospekt Kosmonavtov, 620017
part 744 of the Export Administration States. Yekaterinburg, Russia; and
Regulations (EAR)) identifies entities BIS, pursuant to Section 744.11(b) of (2) Joint Stock Company Federal
and other persons reasonably believed the EAR, and in consultation with the Scientific and Production Center Titan-
to be involved, or to pose a significant Departments of State, Defense, Energy Barrikady, a.k.a., the following three
risk of being or becoming involved, in and the Treasury, has designated the aliases:
activities contrary to the national two persons, located in the Russian —Federal Research and Production
security or foreign policy interests of the Federation, to be added to the Entity Center Titan Barrikady JSC;
United States. The EAR imposes List for actions contrary to the national —Titan Design Bureau; and
additional license requirements on, and security or foreign policy interests of the —JSC FNPTS Titan-Barrikady.
limits the availability of most license United States. Specifically, these Prospekt Imeni V.I. Lenina, b/n
exceptions for, exports, reexports, and entities produced, for the Russian 400071, Volgograd, Russia.
transfers (in-country) to those listed. Federation Ministry of Defense, a
The ‘‘license review policy’’ for each ground-launched cruise missile system, Export Administration Act of 1979
listed entity or other person is identified and associated transporter-erector- Although the Export Administration
in the License Review Policy column on launcher, with a range prohibited by the Act of 1979 expired on August 20, 2001,
the Entity List and the impact on the Intermediate-Range Nuclear Forces the President, through Executive Order
availability of license exceptions is Treaty. Both the Russian Federation and 13222 of August 17, 2001, 3 CFR, 2001
described in the Federal Register the United States are party to the INF Comp., p. 783 (2002), as amended by
document adding entities or other Treaty. Therefore, there is reasonable Executive Order 13637 of March 8,
persons to the Entity List. BIS places cause to believe, based on specific and 2013, 78 FR 16129 (March 13, 2013) and
entities and other persons on the Entity articulable facts, that Joint Stock as extended by the Notice of August 15,
List pursuant to sections of part 744 Company Experimental Design Bureau 2017, 82 FR 39005 (August 16, 2017),
(Control Policy: End-User and End-Use Novator, and Joint Stock Company has continued the Export
Administration Regulations in effect
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Based) and part 746 (Embargoes and Federal Scientific and Production
Other Special Controls) of the EAR. Center Titan-Barrikady have been under the International Emergency
The End-User Review Committee involved in actions contrary to the Economic Powers Act. BIS continues to
(ERC), composed of representatives of national security or foreign policy carry out the provisions of the Export
the Departments of Commerce (Chair), interests of the United States. Administration Act of 1979, as
State, Defense, Energy and, where The prior review of exports, reexports appropriate and to the extent permitted
appropriate, the Treasury, makes all or transfers (in-country) of all items by law, pursuant to Executive Order
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![Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Rules and Regulations 60305
13222, as amended by Executive Order burden, to Jasmeet K. Seehra, Office of public comment be given for this rule.
13637. Management and Budget (OMB), by Because a notice of proposed
email to Jasmeet_K._Seehra@ rulemaking and an opportunity for
Rulemaking Requirements
omb.eop.gov, or by fax to (202) 395– public comment are not required to be
1. Executive Orders 13563 and 12866 7285. given for this rule by 5 U.S.C. 553, or
direct agencies to assess all costs and 3. This rule does not contain policies by any other law, the analytical
benefits of available regulatory with Federalism implications as that requirements of the Regulatory
alternatives and, if regulation is term is defined in Executive Order Flexibility Act, 5 U.S.C. 601 et seq., are
necessary, to select regulatory 13132. not applicable. Accordingly, no
approaches that maximize net benefits 4. For the two persons added to the regulatory flexibility analysis is required
(including potential economic, Entity List in this final rule, the and none has been prepared.
environmental, public health and safety provisions of the Administrative
effects, distributive impacts, and Procedure Act (5 U.S.C. 553) requiring List of Subjects in 15 CFR Part 744
equity). Executive Order 13563 notice of proposed rulemaking, the Exports, Reporting and recordkeeping
emphasizes the importance of opportunity for public participation and requirements, Terrorism.
quantifying both costs and benefits, of a 30-day delay in effective date are
reducing costs, of harmonizing rules, inapplicable because this regulation Accordingly, part 744 of the Export
and of promoting flexibility. This rule involves a military or foreign affairs Administration Regulations (15 CFR
has been determined to be not function of the United States (5 U.S.C. parts 730–774) is amended as follows:
significant for purposes of Executive 553(a)(1)). BIS implementation of this
Order 12866. This rule is not an rule is necessary to protect U.S. national PART 744—[AMENDED]
Executive Order 13771 regulatory action security or foreign policy interests by
because this rule is not significant under preventing items from being exported, ■ 1. The authority citation for part 744
Executive Order 12866. reexported, or transferred (in-country) to is revised to read as follows:
2. Notwithstanding any other the persons being added to the Entity Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C.
provision of law, no person is required List. If this rule were delayed to allow 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C.
to respond to nor be subject to a penalty for notice and comment and a delay in 2139a; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210;
for failure to comply with a collection effective date, the entities being added E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp.,
of information, subject to the to the Entity List by this action would p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993
requirements of the Paperwork Comp., p. 608; E.O. 12938, 59 FR 59099, 3
continue to be able to receive items
CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR
Reduction Act of 1995 (44 U.S.C. 3501 without a license and to conduct 5079, 3 CFR, 1995 Comp., p. 356; E.O. 13026,
et seq.) (PRA), unless that collection of activities contrary to the national 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O.
information displays a currently valid security or foreign policy interests of the 13099, 63 FR 45167, 3 CFR, 1998 Comp., p.
Office of Management and Budget United States. In addition, publishing a 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001
(OMB) Control Number. This regulation proposed rule would give these parties Comp., p. 783; E.O. 13224, 66 FR 49079, 3
involves collections previously notice of the U.S. Government’s CFR, 2001 Comp., p. 786; Notice of January
approved by OMB under control intention to place them on the Entity 13, 2017, 82 FR 6165 (January 18, 2017);
number 0694–0088, Simplified Network List, which could create an incentive for Notice of August 15, 2017, 82 FR 39005
Application Processing System, which these persons to accelerate receiving (August 16, 2017); Notice of September 18,
2017, 82 FR 43825 (September 19, 2017);
includes, among other things, license items subject to the EAR to conduct
Notice of November 6, 2017, 82 FR 51971
applications, and carries a burden activities that are contrary to the (November 8, 2017).
estimate of 43.8 minutes for a manual or national security or foreign policy
electronic submission. interests of the United States, including ■2. Supplement No. 4 to part 744 is
Total burden hours associated with taking steps to set up additional aliases, amended by adding under Russia, two
the PRA and OMB control number change addresses, and other measures to Russian entities.
0694–0088 are not expected to increase try to limit the impact of the listing on The additions read as follows:
as a result of this rule. You may send the Entity List once a final rule is
comments regarding the collection of published. Further, no other law Supplement No. 4 to Part 744—Entity
information associated with this rule, requires that a notice of proposed List
including suggestions for reducing the rulemaking and an opportunity for * * * * *
Country Entity License requirement License review policy Federal Register citation
* * * * * * *
RUSSIA ............ * * * * * *
Joint Stock Company Experimental De- For all items subject to Presumption of denial ...... 82 FR [INSERT FR PAGE
sign Bureau Novator, a.k.a., the fol- the EAR. (See § 744.11 NUMBER], December
lowing two aliases: of the EAR). 12/20/17.
—Novator Design Bureau; and
—JSC OKB Novator.
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18 Prospekt Kosmonavtov, 620017
Yekaterinburg, Russia.
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![60306 Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Rules and Regulations
Country Entity License requirement License review policy Federal Register citation
Joint Stock Company Federal Scientific For all items subject to Presumption of denial ...... 82 FR [INSERT FR PAGE
and Production Center Titan- the EAR. (See § 744.11 NUMBER], 12/20/17.
Barrikady, a.k.a., the following three of the EAR).
aliases:
—Federal Research and Production
Center Titan Barrikady JSC;
—Titan Design Bureau; and
—JSC FNPTS Titan-Barrikady.
Prospekt Imeni V.I. Lenina, b/n 400071,
Volgograd, Russia.
* * * * * * *
Dated: December 15, 2017. MD 20993–0002, 301–796–6398, authorized under section 513(f)(2) of the
Richard E. Ashooh, Jitendra.Virani@fda.hhs.gov. FD&C Act. Section 207 of the Food and
Assistant Secretary for Export SUPPLEMENTARY INFORMATION: Drug Administration Modernization Act
Administration. of 1997 established the first procedure
I. Background for De Novo classification (Pub. L. 105–
[FR Doc. 2017–27388 Filed 12–19–17; 8:45 am]
BILLING CODE 3510–33–P Upon request, FDA has classified the 115). Section 607 of the Food and Drug
image processing device for estimation Administration Safety and Innovation
of external blood loss as class II (special Act modified the De Novo application
DEPARTMENT OF HEALTH AND controls), which we have determined process by adding a second procedure
HUMAN SERVICES will provide a reasonable assurance of (Pub. L. 112–144). A device sponsor
safety and effectiveness. In addition, we may utilize either procedure for De
Food and Drug Administration believe this action will enhance Novo classification.
patients’ access to beneficial innovation, Under the first procedure, the person
21 CFR Part 880 in part by reducing regulatory burdens submits a 510(k) for a device that has
by placing the device into a lower not previously been classified. After
[Docket No. FDA–2017–N–6570] device class than the automatic class III receiving an order from FDA classifying
assignment. the device into class III under section
Medical Devices; General Hospital and The automatic assignment of class III 513(f)(1) of the FD&C Act, the person
Personal Use Devices; Classification occurs by operation of law and without then requests a classification under
of the Image Processing Device for any action by FDA, regardless of the section 513(f)(2).
Estimation of External Blood Loss level of risk posed by the new device. Under the second procedure, rather
AGENCY: Food and Drug Administration, Any device that was not in commercial than first submitting a 510(k) and then
HHS. distribution before May 28, 1976, is a request for classification, if the person
automatically classified as, and remains determines that there is no legally
ACTION: Final order.
within, class III and requires premarket marketed device upon which to base a
SUMMARY: The Food and Drug approval unless and until FDA takes an determination of substantial
Administration (FDA or we) is action to classify or reclassify the device equivalence, that person requests a
classifying the image processing device (see 21 U.S.C. 360c(f)(1)). We refer to classification under section 513(f)(2) of
for estimation of external blood loss into these devices as ‘‘postamendments the FD&C Act.
class II (special controls). The special devices’’ because they were not in Under either procedure for De Novo
controls that apply to the device type commercial distribution prior to the classification, FDA shall classify the
are identified in this order and will be date of enactment of the Medical Device device by written order within 120 days.
part of the codified language for the Amendments of 1976, which amended The classification will be according to
image processing device for estimation the Federal Food, Drug, and Cosmetic the criteria under section 513(a)(1) of
of external blood loss’ classification. We Act (FD&C Act). the FD&C Act. Although the device was
are taking this action because we have FDA may take a variety of actions in automatically placed within class III,
determined that classifying the device appropriate circumstances to classify or the De Novo classification is considered
into class II (special controls) will reclassify a device into class I or II. We to be the initial classification of the
provide a reasonable assurance of safety may issue an order finding a new device device.
to be substantially equivalent under We believe this De Novo classification
and effectiveness of the device. We
section 513(i) of the FD&C Act (21 will enhance patients’ access to
believe this action will also enhance
U.S.C. 360c(i)) to a predicate device that beneficial innovation, in part by
patients’ access to beneficial innovative
does not require premarket approval. reducing regulatory burdens. When FDA
devices, in part by reducing regulatory
We determine whether a new device is classifies a device into class I or II via
burdens. the De Novo process, the device can
substantially equivalent to a predicate
DATES: This order is effective December by means of the procedures for serve as a predicate for future devices of
20, 2017. The classification was
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premarket notification under section that type, including for 510(k)s (see 21
applicable on May 9, 2014. 510(k) of the FD&C Act and part 807 (21 U.S.C. 360c(f)(2)(B)(i)). As a result, other
FOR FURTHER INFORMATION CONTACT: U.S.C. 360(k) and 21 CFR part 807, device sponsors do not have to submit
Jitendra Virani, Center for Devices and respectively). a De Novo request or premarket
Radiological Health, Food and Drug FDA may also classify a device approval application (PMA) in order to
Administration, 10903 New Hampshire through ‘‘De Novo’’ classification, a market a substantially equivalent device
Ave., Bldg. 66, Rm. G459, Silver Spring, common name for the process (see 21 U.S.C. 360c(i), defining
VerDate Sep<11>2014 16:19 Dec 19, 2017 Jkt 244001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\FR\FM\20DER1.SGM 20DER1](https://thefederalregister.org/doc/82_FR_60547/page/3.svg)
Document Created: 2018-10-25 10:57:18
Document Modified: 2018-10-25 10:57:18
| 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. | |
| Dates | This rule is effective December 20, 2017. | |
| Contact | Chair, End-User Review Committee, Office of the Assistant Secretary, Export Administration, Bureau of Industry and Security, Department of Commerce, Phone: (202) 482-5991, Email: [email protected] | |
| FR Citation | 82 FR 60304 | |
| RIN Number | 0694-AG29 | |
| CFR Associated | Exports; Reporting and Recordkeeping Requirements and Terrorism |
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