Food and Drug Administration, HHS.
Proposed rule.
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.
Submit electronic or written comments on this proposed rule or its companion direct final rule by June 29, 2015.
You may submit comments by any of the following methods:
Submit electronic comments in the following way:
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Submit written comments in the following ways:
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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.
FDA is proposing to correct a drafting error regarding fluoroscopic equipment measurement (see § 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, § 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
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 § 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.
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
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,
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
This proposed rule, if finalized, would amend § 1020.32. FDA's authority to modify § 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).
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.
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.
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.
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.
Interested persons may submit either electronic comments regarding this document to
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:
21 U.S.C. 351, 352, 360e-360j, 360hh-360ss, 371, 381.
(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.