[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Rules and Regulations]
[Pages 19530-19532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-08360]



Food and Drug Administration

21 CFR Part 1020

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

Performance Standards for Ionizing Radiation Emitting Products; 
Fluoroscopic Equipment; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.


SUMMARY: The Food and Drug Administration (FDA) is amending 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.

DATES: This rule is effective August 26, 2015. Submit electronic or 
written comments on this direct final rule or its companion proposed 
rule by June 29, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written comments in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-0828 for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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.


I. What is the background of this Rule?

    FDA is correcting a drafting error regarding fluoroscopic equipment 
measurement in Sec.  1020.32 (21 CFR 1020.32). We are publishing this 
direct final rule because it is intended to make a noncontroversial 
amendment to Sec.  1020.32, and we do not anticipate any significant 
adverse comments. Specifically, this amendment changes the words ``any 
linear dimension'' in the current regulation to read ``every linear 
dimension'' (Sec.  1020.32(b)(4)(ii)(A)). The alternative performance 
standard, Sec.  1020.32(b)(4)(ii)(B), currently contains the same 
phrase but remains unchanged. We are amending the language to make the 
performance standards mutually exclusive. This will ensure clarity and 
improve the accuracy of the regulations.
    FDA first proposed the performance standards in the Federal 
Register of December 10, 2002 (67 FR 76056), to account for 
technological changes in fluoroscopic equipment. The proposed rule did 
not specify which measurement of the visible area of an image receptor 
determined the applicable performance standard (67 FR 76056 at 76092). 
When we addressed comments to the proposed rule in the Federal Register 
of June 10, 2005, we agreed with one comment that adding the words 
``any linear dimension'' would clarify the determination of the 
performance standard (70 FR 33998 at 34007).
    FDA ultimately incorporated the phrase in two places, potentially 
reducing the clarity of the rule (70 FR 33998 at 34040). Section 
1020.32(b)(4)(ii) sets performance standards based on a threshold, so 
the language for each standard should be mutually exclusive. That is, 
only one standard, and not the other, should apply to the image 
receptor in question. However, some image receptors may have linear 
dimensions that are both greater than and less than 34 cm, for example, 
receptors with a hexagonal shape. In such cases, the performance 
standards may not be mutually exclusive, so both standards may appear 
to apply. This direct final rule amends Sec.  1020.32(b)(4)(ii)(A) to 
read ``every linear dimension'' to ensure the standards are mutually 
exclusive. The amendment will improve the clarity and accuracy of the 

[[Page 19531]]

II. What are the procedures for issuing a direct Final Rule?

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA 
announced the availability of the guidance document entitled ``Guidance 
for FDA and Industry: Direct Final Rule Procedures'' that described 
when and how we will employ direct final rulemaking. We believe that 
this rule is appropriate for direct final rulemaking because it is 
intended to make a noncontroversial amendment for a minor correction to 
an existing regulation. We anticipate no significant adverse comments.
    Consistent with FDA's procedures on direct final rulemaking, we are 
publishing a companion proposed rule elsewhere in this issue of the 
Federal Register. That proposed rule is identical in substance to this 
direct final rule. The companion proposal will provide a procedural 
framework to finalize a new rule in the event we withdraw this direct 
final rule because we receive significant adverse comment. The comment 
period for this direct final rule runs concurrently with the comment 
period of the companion proposed rule. We will consider any comments 
that we receive in response to the companion proposed rule to be 
comments also regarding this direct final rule and vice versa.
    If FDA receives any significant adverse comments, we will withdraw 
this direct final rule before its effective date by publishing a notice 
in the Federal Register within 30 days after the comment period ends. A 
significant adverse comment is one that explains why the rule would be 
inappropriate (including challenges to the rule's underlying premise or 
approach), ineffective, or unacceptable without change. In determining 
whether an adverse comment is significant and warrants withdrawing a 
direct final rule, we consider whether the comment raises an issue 
serious enough to warrant a substantive response in a notice-and-
comment process in accordance with section 553 of the Administrative 
Procedure Act (APA) (5 U.S.C. 553). Comments that are frivolous, 
insubstantial, or outside the scope of the rule will not be considered 
a significant adverse comment, unless the comment states why the rule 
would be ineffective without the additional change. In addition, if a 
significant adverse comment applies to part of a rule and that part can 
be severed from the remainder of the rule, we may adopt as final those 
parts of the rule that are not the subject of a significant adverse 
    If we withdraw this direct final rule, FDA will consider all 
comments that we received regarding the companion proposed rule as we 
develop a final rule through the usual notice-and-comment procedures of 
the APA (5 U.S.C. 552a, et seq.). If we receive no significant adverse 
comments during the specified comment period regarding this direct 
final rule, we intend to publish a confirmation document in the Federal 
Register within 30 days after the comment period ends.

III. What is the legal authority for this Rule?

    This rule, if finalized, would amend Sec.  1020.32. FDA's authority 
to modify Sec.  1020.32 arises from the same authority under which FDA 
initially issued this regulation, the device and general administrative 
provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 
352, 360e-360j, 360hh-360ss, 371, and 381).

IV. What is the environmental impact of this Rule?

    FDA has determined under 21 CFR 25.30(h) and 25.34(a) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 

V. What is the economic analysis of impact of this Rule?

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this final rule is not a significant 
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this rule does not add any additional 
regulatory burdens, the Agency certifies that this final rule will not 
have a significant economic impact on a substantial number of small 
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $141 million, using the most current (2013) Implicit 
Price Deflator for the Gross Domestic Product. This final rule would 
not result in a 1-year expenditure that meets or exceeds this amount.
    The purpose of this final rule is to correct a drafting error 
regarding fluoroscopic equipment measurement in a performance standard 
for ionizing radiation. The amendment will improve the clarity and 
accuracy of the regulations. Because this final rule is a technical 
correction and would impose no additional regulatory burdens, this 
regulation is not anticipated to result in any compliance costs, and 
the economic impact is expected to be minimal.

VI. How does the Paperwork Reduction Act of 1995 apply to this Rule?

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VII. What are the Federalism implications of this Rule?

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the Agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

VIII. How do you submit comments on this Rule?

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division

[[Page 19532]]

of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at http://www.regulations.gov.

List of Subjects in 21 CFR Part 1020

    Electronic products, Medical devices, Radiation protection, 
Reporting and recordkeeping requirements, Television, X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
1020 is amended as follows:


1. The authority citation for 21 CFR part 1020 continues to read as 

    Authority:  21 U.S.C. 351, 352, 360e-360j, 360hh-360ss, 371, 

2. Revise Sec.  1020.32(b)(4)(ii)(A) to read as follows:

Sec.  1020.32  Fluoroscopic equipment.

    (b) * * *
    (4) * * *
    (ii) * * *
    (A) When every linear dimension of the visible area of the image 
receptor measured through the center of the visible area is less than 
or equal to 34 cm in any direction, at least 80 percent of the area of 
the x-ray field overlaps the visible area of the image.
* * * * *

    Dated: April 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08360 Filed 4-10-15; 8:45 am]