80 FR 43320 - Performance Standards for Ionizing Radiation Emitting Products; Fluoroscopic Equipment; Correction; Confirmation of Effective Date

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 140 (July 22, 2015)

Page Range		43320-43320
FR Document		2015-17930

The Food and Drug Administration (FDA or we) is confirming the effective date of August 26, 2015, for the direct final rule that appeared in the Federal Register of April 13, 2015. The direct final rule amends a Federal performance standard for ionizing radiation to correct a drafting error regarding fluoroscopic equipment measurement. We are taking this action to ensure clarity and improve the accuracy of the regulations. This document confirms the effective date of the direct final rule.

Federal Register, Volume 80 Issue 140 (Wednesday, July 22, 2015)

[Federal Register Volume 80, Number 140 (Wednesday, July 22, 2015)]
[Rules and Regulations]
[Page 43320]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17930]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1020

[Docket No. FDA-2015-N-0828]


Performance Standards for Ionizing Radiation Emitting Products; 
Fluoroscopic Equipment; Correction; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is confirming the 
effective date of August 26, 2015, for the direct final rule that 
appeared in the Federal Register of April 13, 2015. The direct final 
rule amends a Federal performance standard for ionizing radiation to 
correct a drafting error regarding fluoroscopic equipment measurement. 
We are taking this action to ensure clarity and improve the accuracy of 
the regulations. This document confirms the effective date of the 
direct final rule.

DATES: Effective date of the final rule published in the Federal 
Register of April 13, 2015 (80 FR 19530), confirmed: August 26, 2015.

FOR FURTHER INFORMATION CONTACT: Scott Gonzalez, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4641, Silver Spring, MD 20993-0002, 301-796-5889.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 13, 2015 
(80 FR 19530), FDA solicited comments concerning the direct final rule 
for a 75-day period ending June 29, 2015. We stated that the effective 
date of the direct final rule would be on August 26, 2015, 30 days 
after the end of the comment period, unless FDA received any 
significant adverse comment during the comment period. FDA did not 
receive any significant adverse comments.

    Authority: 21 U.S.C. 351, 352, 360e-360j, 360hh-360ss, 371, 381. 
Accordingly, the amendment issued thereby is effective.

    Dated: July 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17930 Filed 7-21-15; 8:45 am]
BILLING CODE 4164-01-P

43320 Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Rules and Regulations

■ 29. In supplement No. 1 to part 774, the accuracy of the regulations. This FOR FURTHER INFORMATION CONTACT:
ECCN 2E994 is amended by revising the document confirms the effective date of Brian McCarthy, Office of Regulatory
‘‘Control(s)’’ paragraph to read as the direct final rule. and Administrative Affairs (10B4),
follows: DATES: Effective date of the final rule Veterans Health Administration,
published in the Federal Register of Department of Veterans Affairs, 810
2E994 ‘‘Technology’’ for the ‘‘use’’ of April 13, 2015 (80 FR 19530), Vermont Ave. NW., Washington, DC
portable electric generators controlled by 20420, (202) 461–6345. (This is not a
2A994.
confirmed: August 26, 2015.
FOR FURTHER INFORMATION CONTACT:
toll-free telephone number.)
License Requirements Scott Gonzalez, Center for Devices and SUPPLEMENTARY INFORMATION: The Office
Radiological Health, Food and Drug of Management and Budget (OMB) is
* * * * * streamlining the Federal government’s
Control(s): AT applies to entire entry. A Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4641, Silver Spring, guidance on Administrative
license is required for items Requirements, Cost Principles, and
controlled by this entry to Iran and MD 20993–0002, 301–796–5889.
Audit Requirements for Federal awards.
North Korea for anti-terrorism SUPPLEMENTARY INFORMATION: In the
In a document published in the Federal
reasons. The Commerce Country Federal Register of April 13, 2015 (80
Register on December 26, 2013 (78 FR
Chart is not designed to determine FR 19530), FDA solicited comments
78590), OMB adopted final guidance,
licensing requirements for this entry. concerning the direct final rule for a 75-
Uniform Administrative Requirements,
See part 746 of the EAR for additional day period ending June 29, 2015. We
Cost Principles, and Audit
information on Iran. See § 742.19 of stated that the effective date of the
Requirements for Federal Awards
the EAR for additional information on direct final rule would be on August 26,
(Uniform Guidance), that supersedes
North Korea. 2015, 30 days after the end of the and streamlines requirements from
* * * * * comment period, unless FDA received OMB Circulars A–21, A–87, A–110, and
any significant adverse comment during A–122 (which have been placed in OMB
ECCN 4A001—[Amended] the comment period. FDA did not guidances); Circulars A–89, A–102, and
■ 30. In supplement No. 1 to part 774, receive any significant adverse A–133; and the guidance in Circular
ECCN 4A003 is amended by adding the comments. A–50 on Single Audit Act follow-up.
phrase ‘‘or E:2’’ immediately following Authority: 21 U.S.C. 351, 352, 360e–360j, The final guidance is located in title 2
the phrase ‘‘Country Group E:1’’ in the 360hh–360ss, 371, 381. Accordingly, the of the Code of Federal Regulations
note that immediately follows the amendment issued thereby is effective. (CFR).
License Requirements table. Dated: July 16, 2015. On December 19, 2014, OMB
Leslie Kux, published a joint interim final rule in
Dated: July 17, 2015.
Associate Commissioner for Policy. the Federal Register (79 FR 75871).
Kevin J. Wolf,
OMB made technical corrections to the
Assistant Secretary for Export [FR Doc. 2015–17930 Filed 7–21–15; 8:45 am]
Uniform Guidance, and Federal
Administration. BILLING CODE 4164–01–P
awarding agencies, including VA,
[FR Doc. 2015–17981 Filed 7–21–15; 8:45 am] implemented the guidance in their
BILLING CODE 3510–33–P respective chapters of title 2 of the CFR.
DEPARTMENT OF VETERANS VA amended title 2 of the CFR to add
AFFAIRS part 802. Section 802.101 of title 2 CFR
DEPARTMENT OF HEALTH AND now provides, ‘‘The Uniform
HUMAN SERVICES 38 CFR Parts 17, 39, 48, 49, 51, 52, 53,
Administrative Requirements, Cost
59, 61, 62, and 64
Principles, and Audit Requirements for
Food and Drug Administration RIN 2900–AP22 Federal Awards set forth in 2 CFR part
200 shall apply to the Department of
21 CFR Part 1020 Uniform Administrative Requirements, Veterans Affairs.’’ VA also removed
Cost Principles, and Audit parts 41 and 43 from title 38 CFR. Those
[Docket No. FDA–2015–N–0828]
Requirements for Federal Awards; parts codified OMB Circulars that were
Performance Standards for Ionizing Updating References superseded by the Uniform Guidance.
Radiation Emitting Products; Because of these changes, existing
AGENCY: Department of Veterans Affairs.
Fluoroscopic Equipment; Correction; references in VA’s regulations to the
ACTION: Final rule. superseded OMB guidance documents
Confirmation of Effective Date
SUMMARY: The Department of Veterans and to parts 41 and 43 are obsolete.
AGENCY: Food and Drug Administration, Accordingly, we are amending various
HHS. Affairs (VA) is amending its regulations
with updated citations and references to VA regulations located in 38 CFR parts
ACTION: Direct final rule; confirmation of Office of Management and Budget 17, 39, 48, 51, 52, 53, 59, 61, 62, and 64
effective date. (OMB) authorities for Federal grant to replace the obsolete references with
programs. OMB has issued final references to the current authority. For
SUMMARY: The Food and Drug the same reason, we are removing part
Administration (FDA or we) is guidance, located in Title 2 of the Code
of Federal Regulations (CFR), which 49 of title 38 CFR, which codified OMB
confirming the effective date of August Circular A–110, and amending VA’s
26, 2015, for the direct final rule that streamlines and supersedes
requirements previously found in regulations referencing part 49 to
appeared in the Federal Register of reference 2 CFR part 200 instead.
Lhorne on DSK7TPTVN1PROD with RULES

April 13, 2015. The direct final rule various OMB Circulars. VA has adopted
amends a Federal performance standard OMB’s guidance, and this rule replaces Administrative Procedure Act
for ionizing radiation to correct a the obsolete OMB references in VA’s The Secretary of Veterans Affairs
drafting error regarding fluoroscopic regulations. finds there is good cause under the
equipment measurement. We are taking DATES: This final rule is effective July provisions of 5 U.S.C. 553(b)(B) and
this action to ensure clarity and improve 22, 2015. (d)(3) to publish this rule without prior

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Document Created: 2015-12-15 12:54:46
Document Modified: 2015-12-15 12:54:46

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		Direct final rule; confirmation of effective date.
Dates		Effective date of the final rule published in the Federal Register of April 13, 2015 (80 FR 19530), confirmed: August 26, 2015.
Contact		Scott Gonzalez, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4641, Silver Spring, MD 20993-0002, 301-796-5889.
FR Citation		80 FR 43320

80 FR 43320 - Performance Standards for Ionizing Radiation Emitting Products; Fluoroscopic Equipment; Correction; Confirmation of Effective Date

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 140 (July 22, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration