82 FR 46900 - Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 194 (October 10, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 194 (October 10, 2017)
| Page Range | 46900-46901 | |
| FR Document | 2017-21659 |
[Federal Register Volume 82, Number 194 (Tuesday, October 10, 2017)] [Rules and Regulations] [Pages 46900-46901] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21659] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2017-N-1620] Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final order; correction. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is correcting a final order entitled ``Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator'' that appeared in the Federal Register of July 28, 2017. The final order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements. This document corrects that error. DATES: Effective October 10, 2017. FOR FURTHER INFORMATION CONTACT: Nathalie Yarkony, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1254, Silver Spring, MD 20993-0002, Nathalie.yarkony@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of July 28, 2017 (82 FR 35065), FDA published the final order ``Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator.'' The final order published with an incorrect statement in the preamble about [[Page 46901]] whether FDA planned to exempt the device from premarket notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)). Correction In the Federal Register of July 28, 2017, in FR Doc. 2017-15901, the following correction is made: On page 35066, at the bottom of the page below table 1, beginning in the first column, the third paragraph is corrected as follows: ``Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the adjunctive cardiovascular status indicator they intend to market.'' Dated: October 2, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-21659 Filed 10-6-17; 8:45 am] BILLING CODE 4164-01-P
![46900 Federal Register / Vol. 82, No. 194 / Tuesday, October 10, 2017 / Rules and Regulations
geographic lat./long. coordinate for the increased ground-to-air, air-to-ground, long. 103°54′40″ W.; to lat. 37°38′10″ N.,
point located in the northeast corner of and air-to-air battle space to increase long. 103°48′47″ W.; to lat. 37°38′32″ N.,
R–2603 has been relocated, so as to not training capacity and relieve training long. 103°48′43″ W.; to lat. 37°38′28″ N.,
impact use of the airway. congestion at Fort Carson. The FAA, long. 103°42′40″ W.; to lat. 37°32′46″ N.,
long. 103°42′46″ W.; to lat. 37°21′10″ N.,
after conducting an independent review
The Rule long. 103°54′41″ W.; to lat. 37°21′15″ N.,
and evaluation of the United States long. 104°02′35″ W.; thence to the point of
The FAA is amending Title 14 Code Army’s Final Environmental Impact beginning.
of Federal Regulations (14 CFR) part 73 Statement of the Pinon Canyon Designated altitudes: Surface to but not
to establish a new restricted area R– Maneuver Site Training and Operations including 10,000 feet Mean Sea Level (MSL).
2603 at the Pinon Canyon Maneuver (EIS) and Record of Decision (ROD) for Time of designation: By NOTAM 24 hours
Site, near Trinidad, CO. The FAA is also Restricted Area R–2603 at Fort Carson, in advance.
incorporating the restricted area updates CO, has determined that the Army’s EIS Controlling agency: FAA, Denver ARTCC.
noted in the Differences from the NPRM and its supporting documentation Using agency: Commander, U.S. Army,
section. The FAA is taking this action to Fort Carson, CO.
adequately assesses and discloses the
ensure realistic Army training which environmental impacts of the Proposed Issued in Washington, DC, on October 3,
provides increased ground-to-air, air-to- Action including evaluation of the 2017.
ground, and air-to-air battle space to establishment of airspace for restricted Scott M. Rosenbloom,
increase training capacity and relieve airspace area R–2603. In March 2013, Acting Manager, Airspace Policy Group.
training congestion at Fort Carson. The the Army Environmental Command and [FR Doc. 2017–21794 Filed 10–6–17; 8:45 am]
changes from what was proposed in the Fort Carson released the EIS regarding BILLING CODE 4910–13–P
NPRM are as follows: the Pinon Canyon Maneuver Site
R–2603: The geographic coordinate (PCMS) Training and Operations located
proposed as ‘‘lat. 37°38′33″ N., long. in Colorado. On May 1, 2015, the Army
103°35′11″ W.’’ in the boundaries DEPARTMENT OF HEALTH AND
issued their ROD. The Army prepared HUMAN SERVICES
description is deleted and replaced by a its EIS and ROD in compliance with
point identified as ‘‘lat. 37°38′28″ N., NEPA and Army-specific environmental Food and Drug Administration
long. 103°42′40″ W.’’ The legal regulations (32 CFR part 651).
description of R–2603 was changed Based on the evaluation for potential 21 CFR Part 870
from a counter clockwise direction to a environmental impact in the Army’s
clockwise direction. [Docket No. FDA–2017–N–1620]
EIS, the FAA, as the Cooperating
Regulatory Notices and Analyses Agency for the Army’s proposed action, Medical Devices; Cardiovascular
concluded that adoption of the Army’s Devices; Classification of the
The FAA has determined that this
EIS evaluating the proposed Adjunctive Cardiovascular Status
regulation only involves an established
establishment of R–2603 is authorized Indicator; Correction
body of technical regulations for which
in accordance with 40 CFR 1506.3,
frequent and routine amendments are AGENCY: Food and Drug Administration,
Adoption. Accordingly, FAA adopts the
necessary to keep them operationally HHS.
Army’s EIS and takes full responsibility
current. It, therefore: (1) Is not a
for the scope and content that address ACTION: Final order; correction.
‘‘significant regulatory action’’ under
the FAA’s airspace establishment
Executive Order 12866; (2) is not a SUMMARY: The Food and Drug
action.
‘‘significant rule’’ under Department of Administration (FDA) is correcting a
Transportation (DOT) Regulatory List of Subjects in 14 CFR Part 73 final order entitled ‘‘Medical Devices;
Policies and Procedures (44 FR 11034; Airspace, Prohibited areas, Restricted Cardiovascular Devices; Classification of
February 26, 1979); and (3) does not areas. the Adjunctive Cardiovascular Status
warrant preparation of a regulatory Indicator’’ that appeared in the Federal
evaluation as the anticipated impact is The Amendment Register of July 28, 2017. The final order
so minimal. Since this is a routine In consideration of the foregoing, the was published with an incorrect
matter that only affects air traffic Federal Aviation Administration statement in the preamble about
procedures and air navigation, it is amends 14 CFR part 73 as follows: whether FDA planned to exempt the
certified that this rule, when device from premarket notification
promulgated, does not have a significant PART 73—SPECIAL USE AIRSPACE requirements. This document corrects
economic impact on a substantial that error.
number of small entities under the ■ 1. The authority citation for part 73
continues to read as follows: DATES: Effective October 10, 2017.
criteria of the Regulatory Flexibility Act.
FOR FURTHER INFORMATION CONTACT:
Authority: 49 U.S.C. 106(f), 106(g); 40103,
Environmental Review 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, Nathalie Yarkony, Center for Devices
The FAA has determined that this 1959–1963 Comp., p. 389. and Radiological Health, Food and Drug
action of establishing restricted area R– Administration, 10903 New Hampshire
§ 73.26 [Amended] Ave., Bldg. 66, Rm. 1254, Silver Spring,
2603 within the existing Fort Carson,
CO, Pinon Canyon Maneuver Site ■ 2. Section 73.26 is amended as MD 20993–0002, Nathalie.yarkony@
(PCMS), near Trinidad, CO, qualifies for follows: fda.hhs.gov.
FAA adoption in accordance with FAA * * * * * SUPPLEMENTARY INFORMATION: In the
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Order 1050.1F, paragraphs 8–2 and 9–2, R–2603 Fort Carson, CO [New] Federal Register of July 28, 2017 (82 FR
Adoption of Other Agencies’ National 35065), FDA published the final order
Boundaries: Beginning lat. 37°22′30″ N.,
Environmental Policy Act Documents, long. 104°04′47″ W.; to lat. 37°32′27″ N.,
‘‘Medical Devices; Cardiovascular
and Written Re-evaluations, and long. 104°06′32″ W.; to lat. 37°32′27″ N., Devices; Classification of the Adjunctive
7400.2L, paragraph 32–2–3. The long. 104°02′15″ W.; to lat. 37°33′21″ N., Cardiovascular Status Indicator.’’ The
purpose of creating and utilizing the long. 103°57′55″ W.; to lat. 37°35′59″ N., final order published with an incorrect
Restricted Area (RA) is to allow for long. 103°57′50″ W.; to lat. 37°35′57″ N., statement in the preamble about
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![Federal Register / Vol. 82, No. 194 / Tuesday, October 10, 2017 / Rules and Regulations 46901
whether FDA planned to exempt the is intended to restrict vessel traffic on Under 5 U.S.C. 553(d)(3), the Coast
device from premarket notification the Atlantic Intracoastal Waterway to Guard finds that good cause exists for
requirements under section 510(k) of the protect mariners, vessels, and training making this temporary rule effective less
Federal Food, Drug, and Cosmetic Act exercise participants from the hazards than 30 days after publication in the
(the FD&C Act) (21 U.S.C. 360(k)). associated with military training Federal Register. Immediate
operations. Entry of vessels or persons implementation is required to protect
Correction
into this safety zone is prohibited unless the public and participants from the
In the Federal Register of July 28, specifically authorized by the Captain of dangers associated with the military
2017, in FR Doc. 2017–15901, the the Port (COTP) North Carolina or a training exercises.
following correction is made: designated representative.
On page 35066, at the bottom of the III. Legal Authority and Need for Rule
DATES: This rule is effective from
page below table 1, beginning in the first
October 10, 2017 through October 30, The Coast Guard is issuing this rule
column, the third paragraph is corrected
2017. under authority in 33 U.S.C. 1231. The
as follows:
‘‘Section 510(m) of the FD&C Act ADDRESSES: To view documents COTP North Carolina has determined
provides that FDA may exempt a class mentioned in this preamble as being that potential hazards associated with
II device from the premarket notification available in the docket, go to http:// the military exercises scheduled from
requirements under section 510(k), if www.regulations.gov, type USCG–2017– October 10 through October 30, 2017, is
FDA determines that premarket 0792 in the ‘‘SEARCH’’ box and click a safety concern for mariners and
notification is not necessary to provide ‘‘SEARCH.’’ Click on Open Docket participants. The military training
reasonable assurance of the safety and Folder on the line associated with this exercises involve building temporary
effectiveness of the device. For this type rule. bridges, crossing with amphibious
of device, FDA has determined that FOR FURTHER INFORMATION CONTACT: If vehicles, and other military operations
premarket notification is necessary to you have questions on this rule, contact on the ICW. These military training
provide reasonable assurance of the Petty Officer Matthew Tyson, activities will block the waterway in a
safety and effectiveness of the device. Waterways Management Division, U.S. manner that restricts all vessel
Therefore, this device type is not Coast Guard Sector North Carolina, navigation and movement within this
exempt from premarket notification Wilmington, NC; telephone: 910–772– segment of the ICW. This rule is
requirements. Persons who intend to 2221, email: Matthew.I.Tyson@uscg.mil. necessary to protect persons and vessels
market this type of device must submit SUPPLEMENTARY INFORMATION: from the potential hazards associated
to FDA a premarket notification, prior to with the military training exercises.
marketing the device, which contains I. Table of Abbreviations
information about the adjunctive IV. Discussion of the Rule
CFR Code of Federal Regulations
cardiovascular status indicator they COTP Captain of the Port
intend to market.’’ The safety zone will be enforced on
DHS Department of Homeland Security
FR Federal Register
the following dates and times in October
Dated: October 2, 2017. 2017:
NPRM Notice of proposed rulemaking
Leslie Kux,
§ Section
Associate Commissioner for Policy. U.S.C. United States Code Date Time
[FR Doc. 2017–21659 Filed 10–6–17; 8:45 am] ICW IntraCoastal Waterway
BILLING CODE 4164–01–P 10th–12th ..... 8 a.m. through 11 a.m. and 1
II. Background Information and p.m. through 4 p.m.
Regulatory History 13th .............. 9 a.m. through 12 p.m. and 1
The Coast Guard is issuing this p.m. through 4 p.m.
DEPARTMENT OF HOMELAND 18th .............. 8 a.m. through 12 p.m.
SECURITY temporary rule without prior notice and
opportunity to comment pursuant to 24th .............. 8 a.m. through 12 p.m. and 1
p.m. through 4 p.m.
Coast Guard authority under section 4(a) of the
25th–26th ..... 9 a.m. through 1 p.m. and 2
Administrative Procedure Act (APA) (5 p.m. through 5 p.m.
33 CFR Part 165 U.S.C. 553(b)). This provision 27th–28th ..... 7 a.m. through 5 p.m.
authorizes an agency to issue a rule 29th–30th ..... 7 a.m. through 11 a.m.
[Docket Number USCG–2017–0792]
without prior notice and opportunity to
RIN 1625–AA00 comment when the agency for good
cause finds that those procedures are The safety zone will include all
Safety Zone; Atlantic Intracoastal ‘‘impracticable, unnecessary, or contrary navigable waters of the ICW from Mile
Waterway, Camp Lejeune, NC to the public interest.’’ Under 5 U.S.C. Hammock Bay, approximate position
553(b)(B), the Coast Guard finds that 34°32′46″ N., 77°19′17″ W., to Onslow
AGENCY: Coast Guard, DHS.
good cause exists for not publishing a Beach Swing Bridge approximate
ACTION: Temporary final rule. position 34°34′25″ N., 77°16′14″ W.
notice of proposed rulemaking (NPRM)
SUMMARY: The Coast Guard is with respect to this rule. The Coast (NAD 1983), an approximately four mile
establishing a temporary safety zone on Guard was notified of the final dates portion of the ICW. The duration of this
the Atlantic Intracoastal Waterway in needed for this rule on August 17, 2017. zone is intended to protect mariners
Camp Lejeune, North Carolina in It is impracticable and contrary to the from the hazards associated with
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support of military training exercises. public interest to delay this action. military training operations. No vessel
This temporary safety zone is intended Waiting for a comment period to run or person will be permitted to enter the
to restrict vessel traffic from a portion of would inhibit the Coast Guards’ ability safety zone unless specifically
the Atlantic Intracoastal Waterway to protect the public and participants authorized by the Captain of the Port
between Mile Hammock Bay and from the dangers associated with the North Carolina or a designated
Onslow Beach Swing Bridge during military exercises scheduled from representative. The regulatory text
military training operations. This action October 10 through October 30, 2017. appears at the end of this document.
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Document Created: 2017-10-07 10:31:56
Document Modified: 2017-10-07 10:31:56
| 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 order; correction. | |
| Dates | Effective October 10, 2017. | |
| Contact | Nathalie Yarkony, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1254, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 82 FR 46900 |
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