80 FR 19530 - 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 | 19530-19532 | |
| FR Document | 2015-08360 |
[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)] [Rules and Regulations] [Pages 19530-19532] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-08360] ======================================================================= ----------------------------------------------------------------------- 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: 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. SUPPLEMENTARY INFORMATION: 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 regulations. [[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 comment. 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 required. 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 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 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: 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. 2015-08360 Filed 4-10-15; 8:45 am] BILLING CODE 4164-01-P
![19530 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations
weeks but you were born at 32 weeks DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT:
gestation (8 weeks premature), then HUMAN SERVICES Scott Gonzalez, Center for Devices and
your CCA is 12 weeks. Radiological Health, Food and Drug
Food and Drug Administration Administration, 10903 New Hampshire
(2) We evaluate developmental delay
in a premature child until the child’s Ave., Bldg. 66, Rm. 4641, Silver Spring,
21 CFR Part 1020 MD 20993–0002, 301–796–5889.
prematurity is no longer a relevant
factor, generally no later than about [Docket No. FDA–2015–N–0828] SUPPLEMENTARY INFORMATION:
chronological age 2. I. What is the background of this Rule?
Performance Standards for Ionizing
(i) If you have not attained age 1 and FDA is correcting a drafting error
Radiation Emitting Products;
were born prematurely, we will assess Fluoroscopic Equipment; Correction regarding fluoroscopic equipment
your development using your CCA. measurement in § 1020.32 (21 CFR
(ii) If you are over age 1 and have a AGENCY: Food and Drug Administration, 1020.32). We are publishing this direct
developmental delay, and prematurity is HHS. final rule because it is intended to make
still a relevant factor, we will decide ACTION: Direct final rule. a noncontroversial amendment to
whether to correct your chronological § 1020.32, and we do not anticipate any
SUMMARY: The Food and Drug significant adverse comments.
age. We will base our decision on our
Administration (FDA) is amending a Specifically, this amendment changes
judgment and all the facts in your case.
Federal performance standard for the words ‘‘any linear dimension’’ in the
If we decide to correct your ionizing radiation to correct a drafting
chronological age, we may correct it by current regulation to read ‘‘every linear
error regarding fluoroscopic equipment dimension’’ (§ 1020.32(b)(4)(ii)(A)). The
subtracting the full number of weeks of measurement. We are taking this action
prematurity or a lesser number of alternative performance standard,
to ensure clarity and improve the § 1020.32(b)(4)(ii)(B), currently contains
weeks. If your developmental delay is accuracy of the regulations.
the result of your medically the same phrase but remains
DATES: This rule is effective August 26, unchanged. We are amending the
determinable impairment(s) and is not 2015. Submit electronic or written
attributable to your prematurity, we will language to make the performance
comments on this direct final rule or its standards mutually exclusive. This will
decide not to correct your chronological companion proposed rule by June 29, ensure clarity and improve the accuracy
age. 2015. of the regulations.
(3) Notwithstanding the provisions in ADDRESSES: You may submit comments FDA first proposed the performance
paragraph (b)(1) of this section, we will by any of the following methods: standards in the Federal Register of
not compute a CCA if the medical December 10, 2002 (67 FR 76056), to
evidence shows that your treating Electronic Submissions account for technological changes in
source or other medical source has Submit electronic comments in the fluoroscopic equipment. The proposed
already taken your prematurity into following way: rule did not specify which measurement
consideration in his or her assessment • Federal eRulemaking Portal: http:// of the visible area of an image receptor
of your development. We will not www.regulations.gov. Follow the determined the applicable performance
compute a CCA when we find you instructions for submitting comments. standard (67 FR 76056 at 76092). When
disabled under listing 100.04 of the we addressed comments to the proposed
Listing of Impairments. Written Submissions rule in the Federal Register of June 10,
Submit written comments in the 2005, we agreed with one comment that
§ 416.926a [Amended] following ways: adding the words ‘‘any linear
■ 5. Amend § 416.926a by removing • Mail/Hand delivery/Courier (for dimension’’ would clarify the
paragraphs (m)(6) and (m)(7) and paper submissions): Division of Dockets determination of the performance
Management (HFA–305), Food and Drug standard (70 FR 33998 at 34007).
redesignating paragraph (m)(8) as (m)(6).
Administration, 5630 Fishers Lane, Rm. FDA ultimately incorporated the
■ 6. Amend § 416.934 by adding 1061, Rockville, MD 20852. phrase in two places, potentially
paragraphs (j) and (k) to read as follows: Instructions: All submissions received reducing the clarity of the rule (70 FR
must include the Docket No. FDA– 33998 at 34040). Section
§ 416.934 Impairments which may warrant 2015–N–0828 for this rulemaking. All 1020.32(b)(4)(ii) sets performance
a finding of presumptive disability or
comments received may be posted standards based on a threshold, so the
presumptive blindness.
without change to http:// language for each standard should be
* * * * * www.regulations.gov, including any mutually exclusive. That is, only one
(j) Infants weighing less than 1200 personal information provided. For standard, and not the other, should
grams at birth, until attainment of 1 year additional information on submitting apply to the image receptor in question.
of age. comments, see the ‘‘Comments’’ heading However, some image receptors may
of the SUPPLEMENTARY INFORMATION have linear dimensions that are both
(k) Infants weighing at least 1200 but
section of this document. greater than and less than 34 cm, for
less than 2000 grams at birth, and who
Docket: For access to the docket to example, receptors with a hexagonal
are small for gestational age, until
read background documents or shape. In such cases, the performance
attainment of 1 year of age. (Small for
comments received, go to http:// standards may not be mutually
wreier-aviles on DSK5TPTVN1PROD with RULES
gestational age means a birth weight that
www.regulations.gov and insert the exclusive, so both standards may appear
is at or more than 2 standard deviations docket number, found in brackets in the to apply. This direct final rule amends
below the mean or that is less than the heading of this document, into the § 1020.32(b)(4)(ii)(A) to read ‘‘every
third growth percentile for the ‘‘Search’’ box and follow the prompts linear dimension’’ to ensure the
gestational age of the infant.) and/or go to the Division of Dockets standards are mutually exclusive. The
[FR Doc. 2015–08185 Filed 4–10–15; 8:45 am] Management, 5630 Fishers Lane, Rm. amendment will improve the clarity and
BILLING CODE 4191–02–P 1061, Rockville, MD 20852. accuracy of the regulations.
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![19532 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations
of Dockets Management between 9 a.m. DATES: Effective: April 13, 2015. manuscripts, books, journals, and
and 4 p.m., Monday through Friday, and FOR FURTHER INFORMATION CONTACT: newspapers, in paper or electronic
will be posted to the docket at http:// Assistant Director for Licensing, tel.: format.
www.regulations.gov. 202/622–2480, Assistant Director for Public Participation
List of Subjects in 21 CFR Part 1020 Policy, tel.: 202/622–6746, Assistant
Director for Regulatory Affairs, tel: 202/ Because the amendment of the
Electronic products, Medical devices, 622–4855, Assistant Director for Regulations involves a foreign affairs
Radiation protection, Reporting and Sanctions Compliance & Evaluation, function, Executive Order 12866 and the
recordkeeping requirements, Television, tel.: 202/622–2490, Office of Foreign provisions of the Administrative
X-rays. Assets Control, or Chief Counsel Procedure Act (5 U.S.C. 553) requiring
Therefore, under the Federal Food, (Foreign Assets Control), tel.: 202/622– notice of proposed rulemaking,
Drug, and Cosmetic Act and under 2410, Office of the General Counsel, opportunity for public participation,
authority delegated to the Commissioner Department of the Treasury (not toll free and delay in effective date are
of Food and Drugs, 21 CFR part 1020 is numbers). inapplicable. Because no notice of
amended as follows: SUPPLEMENTARY INFORMATION: proposed rulemaking is required for this
rule, the Regulatory Flexibility Act (5
PART 1020—PERFORMANCE Electronic and Facsimile Availability U.S.C. 601–612) does not apply.
STANDARDS FOR IONIZING This document and additional
RADIATION EMITTING PRODUCTS Paperwork Reduction Act
information concerning OFAC are
available from OFAC’s Web site The collections of information related
■ 1. The authority citation for 21 CFR
(www.treasury.gov/ofac). Certain general to the Regulations are contained in 31
part 1020 continues to read as follows:
information pertaining to OFAC’s CFR part 501 (the ‘‘Reporting,
Authority: 21 U.S.C. 351, 352, 360e–360j, sanctions programs also is available via Procedures and Penalties Regulations’’).
360hh–360ss, 371, 381. Pursuant to the Paperwork Reduction
facsimile through a 24-hour fax-on-
■ 2. Revise § 1020.32(b)(4)(ii)(A) to read demand service, tel.: 202/622–0077. Act of 1995 (44 U.S.C. 3507), those
as follows: collections of information have been
Background approved by the Office of Management
§ 1020.32 Fluoroscopic equipment. On April 5, 2005, the Office of and Budget under control number 1505–
(b) * * * Foreign Assets Control (OFAC) issued 0164. An agency may not conduct or
(4) * * * the Syrian Sanctions Regulations, 31 sponsor, and a person is not required to
(ii) * * * CFR part 542 (the ‘‘Regulations’’) (70 FR respond to, a collection of information
(A) When every linear dimension of 17201, April 5, 2005), to implement unless the collection of information
the visible area of the image receptor Executive Order 13338 of May 11, 2004 displays a valid control number.
measured through the center of the (69 FR 26751, May 13, 2004) (E.O.
visible area is less than or equal to 34 List of Subjects in 31 CFR Part 542
13338), pursuant to, inter alia, the
cm in any direction, at least 80 percent International Emergency Economic Administrative practice and
of the area of the x-ray field overlaps the Powers Act (50 U.S.C. 1701 et seq.) procedure, Exports, Foreign trade,
visible area of the image. (IEEPA). On May 2, 2014, OFAC Information, Services, Syria.
* * * * * amended the Regulations to implement For the reasons set forth in the
Dated: April 7, 2015. Executive Order 13399 of April 25, 2006 preamble, the Department of the
(71 FR 25059, April 28, 2006) (E.O. Treasury’s Office of Foreign Assets
Leslie Kux,
13399), Executive Order 13460 of Control amends 31 CFR part 542 as set
Associate Commissioner for Policy.
February 13, 2008 (73 FR 8991, forth below:
[FR Doc. 2015–08360 Filed 4–10–15; 8:45 am] February 15, 2008) (E.O. 13460),
BILLING CODE 4164–01–P Executive Order 13572 of April 29, 2011 PART 542—SYRIAN SANCTIONS
(76 FR 24787, May 3, 2011) (E.O. REGULATIONS
13572), Executive Order 13573 of May
DEPARTMENT OF THE TREASURY 18, 2011 (76 FR 29143, May 20, 2011) ■ 1. The authority citation for part 542
(E.O. 13573), Executive Order 13582 of continues to read as follows:
Office of Foreign Assets Control August 17, 2011 (76 FR 52209, August
Authority: 3 U.S.C. 301; 31 U.S.C. 321(b);
22, 2011) (E.O. 13582), and Executive 18 U.S.C. 2332d; 22 U.S.C. 287c; 50 U.S.C.
31 CFR Part 542 Order 13606 of April 22, 2012 (77 FR 1601–1651, 1701–1706; Pub. L. 101–410, 104
24571, April 24, 2012) (E.O. 13606). Stat. 890 (28 U.S.C. 2461 note); Pub. L. 110–
Syrian Sanctions Regulations
Today, OFAC is amending the 96, 121 Stat. 1011 (50 U.S.C. 1701 note); E.O.
AGENCY: Office of Foreign Assets Regulations to authorize certain 13338, 69 FR 26751, 3 CFR, 2004 Comp., p.
Control, Treasury. activities relating to publishing. 168; E.O. 13399, 71 FR 25059, 3 CFR, 2006
With certain exceptions, the Comp., p. 218; E.O. 13460, 73 FR 8991, 3 CFR
ACTION: Final rule.
exportation or importation of 2008 Comp., p. 181; E.O. 13572, 76 FR 24787,
SUMMARY: The Department of the information or informational materials 3 CFR 2011 Comp., p.236; E.O. 13573, 76 FR
29143, 3 CFR 2011 Comp., p. 241; E.O.
Treasury’s Office of Foreign Assets to or from any country is exempt from 13582, 76 FR 52209, 3 CFR 2011 Comp., p.
Control is amending the Syrian regulation by the President under
wreier-aviles on DSK5TPTVN1PROD with RULES
264; E.O. 13606, 77 FR 24571, 3 CFR 2012
Sanctions Regulations to authorize by IEEPA. See 50 U.S.C. 1702(b)(3); 31 CFR Comp., p.243.
general license certain activities relating 542.211(b). OFAC is issuing a new
to publishing, not already exempt from general license set forth at 31 CFR Subpart E—Licenses, Authorizations,
regulation, that support the publishing 542.532 to authorize, subject to certain and Statements of Licensing Policy
and marketing of manuscripts, books, limitations, transactions not already
journals, and newspapers in paper and exempt from regulation that support the ■ 2. Add new § 542.532 to read as
electronic format. publishing and marketing of follows:
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Document Created: 2015-12-18 11:21:43
Document Modified: 2015-12-18 11:21:43
| 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. | |
| 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. | |
| 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 19530 | |
| CFR Associated | Electronic Products; Medical Devices; Radiation Protection; Reporting and Recordkeeping Requirements; Television and X-Rays |
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