81 FR 44770 - Updated Statements of Legal Authority for the Export Administration Regulations
DEPARTMENT OF COMMERCE
Bureau of Industry and Security Federal Register Volume 81, Issue 132 (July 11, 2016)
Bureau of Industry and Security
Federal Register Volume 81, Issue 132 (July 11, 2016)
| Page Range | 44770-44771 | |
| FR Document | 2016-16365 |
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)] [Rules and Regulations] [Pages 44770-44771] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-16365] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Parts 730, 736, 738 and 746 [Docket No. 160622547-6547-01] RIN 0694-AG99 Updated Statements of Legal Authority for the Export Administration Regulations AGENCY: Bureau of Industry and Security, Commerce. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to cite a Presidential notice extending an emergency declared pursuant to the International Emergency Economic Powers Act and also to remove one obsolete citation. This is a procedural rule that only updates authority paragraphs of the EAR to make them current and to avoid confusion. It does not alter any right, obligation or prohibition that applies to any person under the EAR. DATES: The rule is effective July 11, 2016. FOR FURTHER INFORMATION CONTACT: William Arvin, Regulatory Policy Division, Bureau of Industry and Security, Email [email protected], Telephone: (202) 482-2440. SUPPLEMENTARY INFORMATION: Background The authority for parts 730, 736 and 746 of the EAR (15 CFR parts 730, 736 and 744) rests, in part, on Executive Order 13338 of May 11, 2004--Blocking Property of Certain Persons and Prohibiting the Export of Certain Goods to Syria (69 FR 26751, 3 CFR, 2004 Comp., p. 168) and on annual notices by the President continuing that emergency. This rule updates the authority paragraphs in 15 CFR parts 730, 736 and 746 to cite the Notice of May 3, 2016, 81 FR 27293 (May 5, 2016), which continues that emergency. This rule also removes the citation to 30 U.S.C. 185(s), 185(u), which imposed certain restrictions on exports of crude oil, from the authority paragraph of 15 CFR part 738 because, as a result of Division O, Title 1, Section 101, subsection (b) of Public Law 114-113, the EAR no longer imposes a license requirement on exports of crude oil. This rule is purely procedural and makes no changes other than to revise CFR authority citations to make them current. It does not change the text of any section of the EAR, nor does it alter any right, obligation or prohibition that applies to any person under the EAR. Export Administration Act Although the Export Administration Act 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, 78 FR 16129, 3 CFR, 2014 Comp., p. 223 and as extended by the Notice of August 7, 2015, 80 FR 48233 (August 11, 2015), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act (50 U.S.C. 1701). BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 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). This rule does not impose any regulatory burden on the public and is consistent with the goals of Executive Order 13563. This rule has been determined to be not significant for purposes of Executive Order 12866. 2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person 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 rule does not involve any collection of information. 3. This rule does not contain policies with Federalism implications as that term is defined under Executive Order 13132. 4. The Assistant Secretary for Export Administration finds that there is good cause under 5 U.S.C. 553(b)(B) to waive the provisions of the Administrative Procedure Act requiring prior notice and the opportunity for public comment because they are unnecessary. This rule only updates legal authority citations. It clarifies information and is non-discretionary. This rule does not alter any right, obligation or prohibition that applies to any person under the EAR. Because these revisions are not substantive changes, it is unnecessary to provide notice and opportunity for public comment. In addition, the 30-day delay in effectiveness otherwise required by 5 U.S.C. 553(d) is not applicable because this rule is not a substantive rule. Because neither the Administrative Procedure Act nor any other law requires that notice and an opportunity for public comment be given for this rule, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. List of Subjects 15 CFR Part 730 Administrative practice and procedure, Advisory committees, Exports, Reporting and recordkeeping requirements, Strategic and critical materials. 15 CFR Parts 736 and 738 Exports. 15 CFR Part 746 Exports, Reporting and recordkeeping requirements. Accordingly, parts 730, 736, 738 and 746 of the EAR (15 CFR parts 730-774) are amended as follows: [[Page 44771]] PART 730--[AMENDED] 0 1. The authority citation for part 730 is revised to read as follows: Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c; 22 U.S.C. 2151 note; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15 U.S.C. 1824a; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 11912, 41 FR 15825, 3 CFR, 1976 Comp., p. 114; E.O. 12002, 42 FR 35623, 3 CFR, 1977 Comp., p. 133; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12214, 45 FR 29783, 3 CFR, 1980 Comp., p. 256; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., p. 179; E.O. 12918, 59 FR 28205, 3 CFR, 1994 Comp., p. 899; 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. 12981, 60 FR 62981, 3 CFR, 1995 Comp., p. 419; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; 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; E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp., p 168; E.O. 13637, 78 FR 16129, 3 CFR, 2014 Comp., p. 223; Notice of August 7, 2015, 80 FR 48233 (August 11, 2015); Notice of September 18, 2015, 80 FR 57281 (September 22, 2015); Notice of November 12, 2015, 80 FR 70667 (November 13, 2015); Notice of January 20, 2016, 81 FR 3937 (January 22, 2016); Notice of May 3, 2016, 81 FR 27293 (May 5, 2016). PART 736--[AMENDED] 0 2. The authority citation for part 736 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. 2151 note; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp., p. 168; Notice of August 7, 2015, 80 FR 48233 (August 11, 2015); Notice of November 12, 2015, 80 FR 70667 (November 13, 2015); Notice of May 3, 2016, 81 FR 27293 (May 5, 2016). PART 738--[AMENDED] 0 3. The authority citation for part 738 is revised to read as follows: Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 43 U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 7, 2015, 80 FR 48233 (August 11, 2015). PART 746--[AMENDED] 0 4. The authority citation for part 746 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. 287c; Sec. 1503, Pub. L. 108-11, 117 Stat. 559; 22 U.S.C. 6004; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., p. 614; E.O. 12918, 59 FR 28205, 3 CFR, 1994 Comp., p. 899; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp., p 168; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320; Presidential Determination 2007-7, 72 FR 1899, 3 CFR, 2006 Comp., p. 325; Notice of August 7, 2015, 80 FR 48233 (August 11, 2015); Notice of May 3, 2016, 81 FR 27293 (May 5, 2016). Dated: July 6, 2016. Kevin J. Wolf, Assistant Secretary for Export Administration. [FR Doc. 2016-16365 Filed 7-8-16; 8:45 am] BILLING CODE 3510-33-P
![44770 Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Rules and Regulations
AIRAC State City Airport FDC No. FDC date Subject
date
21–Jul–16 MA Beverly ............... Beverly Muni .................................. 6/8851 6/8/16 RNAV (GPS) RWY 16, Amdt 1C.
21–Jul–16 MA Beverly ............... Beverly Muni .................................. 6/8853 6/8/16 RNAV (GPS) RWY 34, Orig-B.
21–Jul–16 SC Mount Pleasant .. Mt Pleasant Rgnl-Faison Field ...... 6/9457 6/8/16 RNAV (GPS) RWY 35, Orig-B.
21–Jul–16 SC Mount Pleasant .. Mt Pleasant Rgnl-Faison Field ...... 6/9459 6/8/16 VOR/DME–A, Amdt 1A.
21–Jul–16 SC Mount Pleasant .. Mt Pleasant Rgnl-Faison Field ...... 6/9460 6/8/16 RNAV (GPS) RWY 17, Orig-B.
[FR Doc. 2016–15989 Filed 7–8–16; 8:45 am] May 3, 2016, 81 FR 27293 (May 5, subject to a penalty for failure to comply
BILLING CODE 4910–13–P 2016), which continues that emergency. with, a collection of information subject
This rule also removes the citation to to the requirements of the Paperwork
30 U.S.C. 185(s), 185(u), which imposed Reduction Act of 1995 (44 U.S.C. 3501
certain restrictions on exports of crude et seq.) (PRA), unless that collection of
DEPARTMENT OF COMMERCE
oil, from the authority paragraph of 15 information displays a currently valid
Bureau of Industry and Security CFR part 738 because, as a result of Office of Management and Budget
Division O, Title 1, Section 101, (OMB) Control Number. This rule does
15 CFR Parts 730, 736, 738 and 746 subsection (b) of Public Law 114–113, not involve any collection of
the EAR no longer imposes a license information.
[Docket No. 160622547–6547–01] requirement on exports of crude oil. 3. This rule does not contain policies
This rule is purely procedural and with Federalism implications as that
RIN 0694–AG99 makes no changes other than to revise term is defined under Executive Order
CFR authority citations to make them 13132.
Updated Statements of Legal Authority 4. The Assistant Secretary for Export
current. It does not change the text of
for the Export Administration Administration finds that there is good
any section of the EAR, nor does it alter
Regulations cause under 5 U.S.C. 553(b)(B) to waive
any right, obligation or prohibition that
AGENCY: Bureau of Industry and applies to any person under the EAR. the provisions of the Administrative
Security, Commerce. Procedure Act requiring prior notice
Export Administration Act and the opportunity for public comment
ACTION: Final rule.
Although the Export Administration because they are unnecessary. This rule
SUMMARY: This rule updates the Code of Act expired on August 20, 2001, the only updates legal authority citations. It
Federal Regulations (CFR) legal President, through Executive Order clarifies information and is non-
authority paragraphs in the Export 13222 of August 17, 2001, 3 CFR, 2001 discretionary. This rule does not alter
Administration Regulations (EAR) to Comp., p. 783 (2002), as amended by any right, obligation or prohibition that
cite a Presidential notice extending an Executive Order 13637, 78 FR 16129, 3 applies to any person under the EAR.
emergency declared pursuant to the CFR, 2014 Comp., p. 223 and as Because these revisions are not
International Emergency Economic extended by the Notice of August 7, substantive changes, it is unnecessary to
Powers Act and also to remove one 2015, 80 FR 48233 (August 11, 2015), provide notice and opportunity for
obsolete citation. This is a procedural has continued the Export public comment. In addition, the 30-day
rule that only updates authority Administration Regulations in effect delay in effectiveness otherwise
paragraphs of the EAR to make them under the International Emergency required by 5 U.S.C. 553(d) is not
current and to avoid confusion. It does Economic Powers Act (50 U.S.C. 1701). applicable because this rule is not a
not alter any right, obligation or BIS continues to carry out the substantive rule. Because neither the
prohibition that applies to any person provisions of the Export Administration Administrative Procedure Act nor any
under the EAR. Act, as appropriate and to the extent other law requires that notice and an
permitted by law, pursuant to Executive opportunity for public comment be
DATES: The rule is effective July 11,
Order 13222 as amended by Executive given for this rule, the analytical
2016.
Order 13637. requirements of the Regulatory
FOR FURTHER INFORMATION CONTACT: Flexibility Act (5 U.S.C. 601 et seq.) are
William Arvin, Regulatory Policy Rulemaking Requirements not applicable.
Division, Bureau of Industry and 1. Executive Orders 13563 and 12866
Security, Email william.arvin@ List of Subjects
direct agencies to assess all costs and
bis.doc.gov, Telephone: (202) 482–2440. benefits of available regulatory 15 CFR Part 730
SUPPLEMENTARY INFORMATION: alternatives and, if regulation is Administrative practice and
necessary, to select regulatory procedure, Advisory committees,
Background approaches that maximize net benefits Exports, Reporting and recordkeeping
The authority for parts 730, 736 and (including potential economic, requirements, Strategic and critical
746 of the EAR (15 CFR parts 730, 736 environmental, public health and safety materials.
and 744) rests, in part, on Executive effects, distributive impacts, and
Order 13338 of May 11, 2004—Blocking equity). This rule does not impose any 15 CFR Parts 736 and 738
Property of Certain Persons and regulatory burden on the public and is Exports.
Prohibiting the Export of Certain Goods consistent with the goals of Executive
ehiers on DSK5VPTVN1PROD with RULES
to Syria (69 FR 26751, 3 CFR, 2004 15 CFR Part 746
Order 13563. This rule has been
Comp., p. 168) and on annual notices by determined to be not significant for Exports, Reporting and recordkeeping
the President continuing that purposes of Executive Order 12866. requirements.
emergency. This rule updates the 2. Notwithstanding any other Accordingly, parts 730, 736, 738 and
authority paragraphs in 15 CFR parts provision of law, no person is required 746 of the EAR (15 CFR parts 730–774)
730, 736 and 746 to cite the Notice of to respond to, nor shall any person be are amended as follows:
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![Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Rules and Regulations 44771
PART 730—[AMENDED] PART 746—[AMENDED] I. Background
■ 4. The authority citation for part 746 In accordance with section 513(f)(1) of
■ 1. The authority citation for part 730
is revised to read as follows: the Federal Food, Drug, and Cosmetic
is revised to read as follows:
Act (the FD&C Act) (21 U.S.C.
Authority: 50 U.S.C. 4601 et seq.; 50 Authority: 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 et seq.; 22 U.S.C. 287c; Sec. 360c(f)(1)), devices that were not in
U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. commercial distribution before May 28,
1503, Pub. L. 108–11, 117 Stat. 559; 22 U.S.C.
7430(e); 22 U.S.C. 287c; 22 U.S.C. 2151 note; 1976 (the date of enactment of the
6004; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210;
22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42
E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., Medical Device Amendments of 1976),
U.S.C. 2139a; 15 U.S.C. 1824a; 50 U.S.C.
p. 614; E.O. 12918, 59 FR 28205, 3 CFR, 1994 generally referred to as postamendments
4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210;
Comp., p. 899; E.O. 13222, 66 FR 44025, 3 devices, are classified automatically by
E.O. 11912, 41 FR 15825, 3 CFR, 1976 Comp., CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR
p. 114; E.O. 12002, 42 FR 35623, 3 CFR, 1977 statute into class III without any FDA
26751, 3 CFR, 2004 Comp., p 168;
Comp., p. 133; E.O. 12058, 43 FR 20947, 3 rulemaking process. These devices
Presidential Determination 2003–23, 68 FR
CFR, 1978 Comp., p. 179; E.O. 12214, 45 FR 26459, 3 CFR, 2004 Comp., p. 320; remain in class III and require
29783, 3 CFR, 1980 Comp., p. 256; E.O. Presidential Determination 2007–7, 72 FR premarket approval, unless and until
12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 1899, 3 CFR, 2006 Comp., p. 325; Notice of the device is classified or reclassified
608; E.O. 12854, 58 FR 36587, 3 CFR, 1993 August 7, 2015, 80 FR 48233 (August 11, into class I or II, or FDA issues an order
Comp., p. 179; E.O. 12918, 59 FR 28205, 3 2015); Notice of May 3, 2016, 81 FR 27293 finding the device to be substantially
CFR, 1994 Comp., p. 899; E.O. 12938, 59 FR (May 5, 2016). equivalent, in accordance with section
59099, 3 CFR, 1994 Comp., p. 950; E.O. 513(i) of the FD&C Act, to a predicate
Dated: July 6, 2016.
12947, 60 FR 5079, 3 CFR, 1995 Comp., p.
Kevin J. Wolf, device that does not require premarket
356; E.O. 12981, 60 FR 62981, 3 CFR, 1995
Comp., p. 419; E.O. 13020, 61 FR 54079, 3 Assistant Secretary for Export approval. The Agency determines
CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR Administration. whether new devices are substantially
58767, 3 CFR, 1996 Comp., p. 228; E.O. [FR Doc. 2016–16365 Filed 7–8–16; 8:45 am] equivalent to predicate devices by
13099, 63 FR 45167, 3 CFR, 1998 Comp., p. BILLING CODE 3510–33–P
means of premarket notification
208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 procedures in section 510(k) of the
Comp., p. 783; E.O. 13224, 66 FR 49079, 3 FD&C Act (21 U.S.C. 360(k)) and part
CFR, 2001 Comp., p. 786; E.O. 13338, 69 FR 807 (21 CFR part 807) of the regulations.
26751, 3 CFR, 2004 Comp., p 168; E.O. DEPARTMENT OF HEALTH AND Section 513(f)(2) of the FD&C Act, as
13637, 78 FR 16129, 3 CFR, 2014 Comp., p.
HUMAN SERVICES amended by section 607 of the Food and
223; Notice of August 7, 2015, 80 FR 48233
(August 11, 2015); Notice of September 18,
Drug Administration Safety and
Food and Drug Administration Innovation Act (Pub. L. 112–144),
2015, 80 FR 57281 (September 22, 2015);
Notice of November 12, 2015, 80 FR 70667 provides two procedures by which a
(November 13, 2015); Notice of January 20, 21 CFR Part 882 person may request FDA to classify a
2016, 81 FR 3937 (January 22, 2016); Notice device under the criteria set forth in
of May 3, 2016, 81 FR 27293 (May 5, 2016). [Docket No. FDA–2016–N–1653] section 513(a)(1). Under the first
procedure, the person submits a
PART 736—[AMENDED] Medical Devices; Neurological premarket notification under section
Devices; Classification of the Thermal 510(k) of the FD&C Act for a device that
■ 2. The authority citation for part 736 System for Insomnia has not previously been classified and,
is revised to read as follows: within 30 days of receiving an order
AGENCY: Food and Drug Administration,
Authority: 50 U.S.C. 4601 et seq.; 50 classifying the device into class III
HHS.
U.S.C. 1701 et seq.; 22 U.S.C. 2151 note; E.O. under section 513(f)(1) of the FD&C Act,
ACTION: Final order. the person requests a classification
12938, 59 FR 59099, 3 CFR, 1994 Comp., p.
950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 SUMMARY: The Food and Drug under section 513(f)(2). Under the
Comp., p. 219; E.O. 13026, 61 FR 58767, 3 Administration (FDA) is classifying the second procedure, rather than first
CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR
thermal system for insomnia into class submitting a premarket notification
44025, 3 CFR, 2001 Comp., p. 783; E.O. under section 510(k) of the FD&C Act
13338, 69 FR 26751, 3 CFR, 2004 Comp., p.
II (special controls). The special controls
that will apply to the device are and then a request for classification
168; Notice of August 7, 2015, 80 FR 48233 under the first procedure, the person
(August 11, 2015); Notice of November 12, identified in this order and will be part
of the codified language for the thermal determines that there is no legally
2015, 80 FR 70667 (November 13, 2015); marketed device upon which to base a
Notice of May 3, 2016, 81 FR 27293 (May 5, system for insomnia’s classification. The
Agency is classifying the device into determination of substantial
2016).
class II (special controls) in order to equivalence and requests a classification
PART 738—[AMENDED] provide a reasonable assurance of safety under section 513(f)(2) of the FD&C Act.
and effectiveness of the device. If the person submits a request to
■ 3. The authority citation for part 738 classify the device under this second
DATES: This order is effective July 11,
is revised to read as follows: procedure, FDA may decline to
2016. The classification was applicable undertake the classification request if
Authority: 50 U.S.C. 4601 et seq.; 50 on May 13, 2016. FDA identifies a legally marketed device
U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. FOR FURTHER INFORMATION CONTACT: that could provide a reasonable basis for
7430(e); 22 U.S.C. 287c; 22 U.S.C. 3201 et Leigh Anderson, Center for Devices and review of substantial equivalence with
ehiers on DSK5VPTVN1PROD with RULES
seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 43 Radiological Health, Food and Drug
U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. 4305;
the device or if FDA determines that the
Administration, 10903 New Hampshire device submitted is not of ‘‘low-
22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O.
13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
Ave., Bldg. 66, Rm. 2656, Silver Spring, moderate risk’’ or that general controls
228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 MD 20993–0002, 301–796–5613, would be inadequate to control the risks
Comp., p. 783; Notice of August 7, 2015, 80 leigh.anderson@fda.hhs.gov. and special controls to mitigate the risks
FR 48233 (August 11, 2015). SUPPLEMENTARY INFORMATION: cannot be developed.
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Document Created: 2016-07-09 00:21:39
Document Modified: 2016-07-09 00:21:39
| 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 | The rule is effective July 11, 2016. | |
| Contact | William Arvin, Regulatory Policy Division, Bureau of Industry and Security, Email [email protected], Telephone: (202) 482-2440. | |
| FR Citation | 81 FR 44770 | |
| RIN Number | 0694-AG99 | |
| CFR Citation | 15
CFR
730 15 CFR 736 15 CFR 738 15 CFR 746 | |
| CFR Associated | Administrative Practice and Procedure; Advisory Committees; Exports; Reporting and Recordkeeping Requirements and Strategic and Critical Materials |
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