Document ID: FDA-2015-N-0828-0002
Agency: fda
Document Type: Proposed Rule
Title: Performance Standards for Ionizing Radiation Emitting Products;
Fluoroscopic Equipment; Correction
Posted Date: 2015-04-13T04:00Z

[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Proposed Rules]
[Pages 19589-19591]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08361]

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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 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: Submit electronic or written comments on this proposed rule or 
its companion direct final 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.

SUPPLEMENTARY INFORMATION:

I. What is the background of this Proposed Rule?

    FDA is proposing to correct a drafting error regarding fluoroscopic 
equipment measurement (see Sec.  1020.32 (21 CFR 1020.32)). 
Specifically, this proposed amendment would change the words ``any 
linear dimension'' in the current regulation to read ``every linear 
dimension'' (see 21 CFR 1020.32(b)(4)(ii)(A)). The alternative 
performance standard, Sec.  1020.32(b)(4)(ii)(B), currently contains 
the same phrase but would remain unchanged. We are proposing to amend 
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. That 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 that 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 proposed rule would amend 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 
regulations.

II. Why is FDA publishing this companion Proposed Rule?

    This proposed rule is a companion to a direct final rule that 
corrects a drafting error regarding fluoroscopic equipment measurement. 
The direct final rule is published in the final rules section of this 
issue of the Federal Register. The direct final rule and this companion 
proposed rule are substantively identical. This companion proposed rule 
will provide the procedural framework to finalize a new rule in the 
event we withdraw the direct final rule because we receive significant 
adverse comment. We are publishing the direct final rule because we 
believe it is

[[Page 19590]]

noncontroversial, and we do not anticipate any significant adverse 
comments. If we do not receive any significant adverse comments in 
response to the direct final rule, we will not take any further action 
on this proposed rule. Instead, within 30 days after the comment period 
ends, we intend to publish a notice that confirms the effective date of 
the direct final rule.
    If FDA receives any significant adverse comments regarding the 
direct final rule, we will withdraw it within 30 days after the comment 
period ends. We will then proceed to respond to the comments under this 
companion proposed rule using our usual notice-and-comment rulemaking 
procedures under the Administrative Procedure Act (APA) (5 U.S.C. 552a, 
et seq.). The comment period for this companion proposed rule runs 
concurrently with the direct final rule's comment period. We will 
consider any comments that we receive in response to this companion 
proposed rule to be comments also regarding the direct final rule and 
vice versa. We will not provide additional opportunity for comment.
    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 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 comment.
    You can find additional information about FDA's direct final 
rulemaking procedures in the guidance document entitled ``Guidance for 
FDA and Industry: Direct Final Rule Procedures,'' announced in the 
Federal Register of November 21, 1997 (62 FR 62466).

III. What is the legal authority for this Proposed Rule?

    This proposed 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 Proposed 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 
required.

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

    FDA has examined the impacts of the proposed 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 proposed rule would not be a 
significant regulatory action as defined by 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 proposed rule does not add any 
additional regulatory burdens, the Agency has determined that this 
proposed rule would not have a significant economic impact on a 
substantial number of small entities.
    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 proposed rule would 
not result in a 1-year expenditure that meets or exceeds this amount.
    The purpose of this proposed 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 proposed 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 proposed 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 proposed 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 Proposed 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 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 proposed to be amended as follows:

[[Page 19591]]

PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING 
PRODUCTS

0
1. The authority citation for 21 CFR part 1020 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360e-360j, 360hh-360ss, 371, 381.

0
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. 2015-08361 Filed 4-10-15; 8:45 am]
BILLING CODE 4164-01-P