80 FR 19589 - Performance Standards for Ionizing Radiation Emitting Products; Fluoroscopic Equipment; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 70 (April 13, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 70 (April 13, 2015)
| Page Range | 19589-19591 | |
| FR Document | 2015-08361 |
[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)] [Proposed Rules] [Pages 19589-19591] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-08361] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Proposed Rules 19589
identify electronically within the disk or ACTION: Proposed rule. ‘‘any linear dimension’’ in the current
CD ROM the specific information that is regulation to read ‘‘every linear
proprietary or confidential. SUMMARY: The Food and Drug dimension’’ (see 21 CFR
Under 14 CFR 11.35(b), if the FAA is Administration (FDA) is proposing to 1020.32(b)(4)(ii)(A)). The alternative
aware of proprietary information filed amend a Federal performance standard performance standard,
with a comment, the agency does not for ionizing radiation to correct a § 1020.32(b)(4)(ii)(B), currently contains
place it in the docket. It is held in a drafting error regarding fluoroscopic the same phrase but would remain
separate file to which the public does equipment measurement. We are taking unchanged. We are proposing to amend
not have access, and the FAA places a this action to ensure clarity and improve the language to make the performance
note in the docket that it has received the accuracy of the regulations. standards mutually exclusive. This will
it. If the FAA receives a request to DATES: Submit electronic or written ensure clarity and improve the accuracy
examine or copy this information, it comments on this proposed rule or its of the regulations.
treats it as any other request under the companion direct final rule by June 29, FDA first proposed the performance
Freedom of Information Act (5 U.S.C. 2015. standards in the Federal Register of
552). The FAA processes such a request ADDRESSES: You may submit comments December 10, 2002 (67 FR 76056), to
under Department of Transportation by any of the following methods: account for technological changes in
procedures found in 49 CFR part 7. fluoroscopic equipment. That proposed
Electronic Submissions rule did not specify which measurement
B. Availability of Rulemaking of the visible area of an image receptor
Submit electronic comments in the
Documents determined the applicable performance
following way:
An electronic copy of rulemaking • Federal eRulemaking Portal: http:// standard (67 FR 76056 at 76092). When
documents may be obtained from the www.regulations.gov. Follow the we addressed comments to that
Internet by— instructions for submitting comments. proposed rule in the Federal Register of
1. Searching the Federal eRulemaking June 10, 2005, we agreed with one
Portal (http://www.regulations.gov); Written Submissions comment that adding the words ‘‘any
2. Visiting the FAA’s Regulations and Submit written comments in the linear dimension’’ would clarify the
Policies Web page at http:// following ways: determination of the performance
www.faa.gov/regulations_policies or • Mail/Hand delivery/Courier (for standard (70 FR 33998 at 34007).
3. Accessing the Government Printing paper submissions): Division of Dockets FDA ultimately incorporated the
Office’s Web page at http:// Management (HFA–305), Food and Drug phrase in two places, potentially
www.gpo.gov/fdsys/. Administration, 5630 Fishers Lane, Rm. reducing the clarity of the rule (70 FR
Copies may also be obtained by 1061, Rockville, MD 20852. 33998 at 34040). Section
sending a request to the Federal Instructions: All submissions received 1020.32(b)(4)(ii) sets performance
Aviation Administration, Office of must include the Docket No. FDA– standards based on a threshold, so the
Rulemaking, ARM–1, 800 Independence 2015–N–0828 for this rulemaking. All language for each standard should be
Avenue SW., Washington, DC 20591, or comments received may be posted mutually exclusive. That is, only one
by calling (202) 267–9677. Commenters without change to http:// standard, and not the other, should
must identify the docket or notice www.regulations.gov, including any apply to the image receptor in question.
number of this rulemaking. personal information provided. For However, some image receptors may
All documents the FAA considered in additional information on submitting have linear dimensions that are both
developing this proposed rule, comments, see the ‘‘Comments’’ heading greater than and less than 34 cm, for
including technical reports, may be of the SUPPLEMENTARY INFORMATION example, receptors with a hexagonal
shape. In such cases, the performance
accessed from the Internet through the section of this document.
standards may not be mutually
Federal eRulemaking Portal referenced Docket: For access to the docket to
exclusive, so both standards may appear
in item (1) above. read background documents or
to apply. This proposed rule would
Issued under authority provided by 49 comments received, go to http://
amend § 1020.32(b)(4)(ii)(A) to read
U.S.C. 106(f), 40103(b), and 44701(a)(5), in www.regulations.gov and insert the
‘‘every linear dimension’’ to ensure the
Washington, DC, on March 31, 2015. docket number, found in brackets in the
standards are mutually exclusive. The
Abigail Smith, heading of this document, into the
amendment will improve the clarity and
Director, Aeronautical Information Services. ‘‘Search’’ box and follow the prompts
accuracy of the regulations.
[FR Doc. 2015–08098 Filed 4–10–15; 8:45 am]
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm. II. Why is FDA publishing this
BILLING CODE 4910–13–P
1061, Rockville, MD 20852. companion Proposed Rule?
FOR FURTHER INFORMATION CONTACT: This proposed rule is a companion to
DEPARTMENT OF HEALTH AND Scott Gonzalez, Center for Devices and a direct final rule that corrects a drafting
HUMAN SERVICES Radiological Health, Food and Drug error regarding fluoroscopic equipment
Administration, 10903 New Hampshire measurement. The direct final rule is
Food and Drug Administration Ave., Bldg. 66, Rm. 4641, Silver Spring, published in the final rules section of
MD 20993–0002, 301–796–5889. this issue of the Federal Register. The
wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
21 CFR Part 1020 SUPPLEMENTARY INFORMATION: direct final rule and this companion
proposed rule are substantively
[Docket No. FDA–2015–N–0828] I. What is the background of this identical. This companion proposed
Proposed Rule? rule will provide the procedural
Performance Standards for Ionizing
Radiation Emitting Products; FDA is proposing to correct a drafting framework to finalize a new rule in the
Fluoroscopic Equipment; Correction error regarding fluoroscopic equipment event we withdraw the direct final rule
measurement (see § 1020.32 (21 CFR because we receive significant adverse
AGENCY: Food and Drug Administration, 1020.32)). Specifically, this proposed comment. We are publishing the direct
HHS. amendment would change the words final rule because we believe it is
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![Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Proposed Rules 19591
PART 1020—PERFORMANCE ADDRESSES: Submit comments, believe this SIP revision is not
STANDARDS FOR IONIZING identified by docket number EPA–R09– controversial. If we receive adverse
RADIATION EMITTING PRODUCTS OAR–2014–0832, by one of the comments, however, we will publish a
following methods: timely withdrawal of the direct final
■ 1. The authority citation for 21 CFR 1. Federal eRulemaking Portal: rule and address the comments in
part 1020 continues to read as follows: www.regulations.gov. Follow the on-line subsequent action based on this
Authority: 21 U.S.C. 351, 352, 360e–360j, instructions. proposal. Please note that if we receive
360hh–360ss, 371, 381. 2. Email: steckel.andrew@epa.gov. adverse comment on a specific
■ 2. Revise § 1020.32(b)(4)(ii)(A) to read 3. Mail or deliver: Andrew Steckel provision of this SIP revision and if that
as follows: (Air-4), U.S. Environmental Protection provision may be severed from the
Agency Region IX, 75 Hawthorne Street, remainder of the SIP revision, we may
§ 1020.32 Fluoroscopic equipment. San Francisco, CA 94105–3901. adopt as final those provisions of the
(b) * * * Instructions: All comments will be SIP revision that are not the subject of
(4) * * * included in the public docket without an adverse comment.
(ii) * * * change and may be made available We do not plan to open a second
(A) When every linear dimension of online at www.regulations.gov, comment period, so anyone interested
the visible area of the image receptor including any personal information in commenting should do so at this
measured through the center of the provided, unless the comment includes time. If we do not receive adverse
visible area is less than or equal to 34 Confidential Business Information (CBI) comments, no further activity is
cm in any direction, at least 80 percent or other information whose disclosure is planned. For further information, please
of the area of the x-ray field overlaps the restricted by statute. Information that see the direct final action.
visible area of the image. you consider CBI or otherwise protected Dated: February 12, 2015.
* * * * * should be clearly identified as such and Alexis Strauss,
Dated: April 7, 2015.
should not be submitted through Acting Regional Administrator, Region IX.
www.regulations.gov or email. [FR Doc. 2015–08419 Filed 4–10–15; 8:45 am]
Leslie Kux,
www.regulations.gov is an ‘‘anonymous
Associate Commissioner for Policy. BILLING CODE 6560–50–P
access’’ system, and EPA will not know
[FR Doc. 2015–08361 Filed 4–10–15; 8:45 am] your identity or contact information
BILLING CODE 4164–01–P unless you provide it in the body of ENVIRONMENTAL PROTECTION
your comment. If you send email AGENCY
directly to EPA, your email address will
ENVIRONMENTAL PROTECTION be automatically captured and included 40 CFR Part 52
AGENCY as part of the public comment. If EPA
[EPA–R03–OAR–2015–0166; FRL–9926–16–
cannot read your comment due to Region 3]
40 CFR Part 52 technical difficulties and cannot contact
[EPA–R09–OAR–2014–0832; FRL–9925–34– you for clarification, EPA may not be Approval and Promulgation of Air
Region 9] able to consider your comment. Quality Implementation Plans;
Electronic files should avoid the use of Pennsylvania; Adoption of Control
Revisions to the California State special characters, any form of Techniques Guidelines for Offset
Implementation Plan, Northern Sierra encryption, and be free of any defects or Lithographic Printing and Letterpress
Air Quality Management District viruses. Printing; Flexible Package Printing;
AGENCY: Environmental Protection Docket: Generally, documents in the and Adhesives, Sealants, Primers, and
Agency. docket for this action are available Solvents
electronically at www.regulations.gov
ACTION: Proposed rule. AGENCY: Environmental Protection
and in hard copy at EPA Region IX, 75
Hawthorne Street, San Francisco, Agency (EPA).
SUMMARY: The Environmental Protection
California 94105–3901. While all ACTION: Proposed rule.
Agency (EPA) is proposing to approve a
revision to the Northern Sierra Air documents in the docket are listed at SUMMARY: The Environmental Protection
Quality Management District www.regulations.gov, some information Agency (EPA) is proposing to approve
(NSAQMD) portion of the California may be publicly available only at the revisions to the Pennsylvania State
State Implementation Plan (SIP). The hard copy location (e.g., copyrighted Implementation Plan (SIP) submitted by
submitted SIP revision contains the material, large maps), and some may not the Commonwealth of Pennsylvania.
District’s demonstration regarding be publicly available in either location These revisions pertain to control of
Reasonably Available Control (e.g., CBI). To inspect the hard copy volatile organic compound (VOC)
Technology (RACT) requirements for materials, please schedule an emissions from offset lithographic
the 1997 8-hour ozone National appointment during normal business printing and letterpress printing,
Ambient Air Quality Standards hours with the contact listed in the FOR flexible package printing, and
(NAAQS). The submitted SIP revision FURTHER INFORMATION CONTACT section. adhesives, sealants, primers, and
also contains negative declarations for FOR FURTHER INFORMATION CONTACT: solvents. These revisions also meet the
wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
volatile organic compound (VOC) James Shears, EPA Region IX, (213) requirement to adopt Reasonably
source categories for the NSAQMD. We 244–1810, shears.james@epa.gov. Available Control Technology (RACT)
are proposing to approve the submitted SUPPLEMENTARY INFORMATION: This for sources covered by EPA’s Control
SIP revision under the Clean Air Act as proposal addresses the revisions to the Technique Guidelines (CTG)
amended in 1990 (CAA or the Act). We NSAQMD portion of the California SIP. recommendations for the following
are taking comments on this proposal In the rules and regulations section of categories: Offset lithographic printing
and plan to follow with a final action. the Federal Register, we are approving and letterpress printing, flexible
DATES: Any comments on this proposal the SIP revision in a direct final action package printing, and adhesives,
must arrive by May 13, 2015. without prior proposal because we sealants, primers, and solvents. This
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Document Created: 2015-12-18 11:22:34
Document Modified: 2015-12-18 11:22:34
| 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 | Proposed Rules | |
| Action | Proposed rule. | |
| Dates | Submit electronic or written comments on this proposed rule or its companion direct final rule by June 29, 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 19589 | |
| CFR Associated | Electronic Products; Medical Devices; Radiation Protection; Reporting and Recordkeeping Requirements; Television and X-Rays |
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