83_FR_13926 83 FR 13863 - Medical Devices; Technical Amendment

83 FR 13863 - Medical Devices; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 63 (April 2, 2018)

Page Range13863-13865
FR Document2018-06308

The Food and Drug Administration (FDA or Agency) is amending certain medical device regulations. This action is editorial in nature to correct typographical errors and to ensure accuracy and clarity in the Agency's regulations.

Federal Register, Volume 83 Issue 63 (Monday, April 2, 2018) 
[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Rules and Regulations]
[Pages 13863-13865]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06308]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 890, 900, 1020, and 1040

[Docket No. FDA-2018-N-0011]


Medical Devices; Technical Amendment

AGENCY: Food and Drug Administration; HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is amending 
certain medical device regulations. This action is editorial in nature 
to correct typographical errors and to ensure accuracy and clarity in 
the Agency's regulations.

DATES: This rule is effective April 2, 2018.

FOR FURTHER INFORMATION CONTACT: Karen Fikes, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993-0002, 301-796-9603.

SUPPLEMENTARY INFORMATION: FDA is amending our regulations in 21 CFR 
parts 890, 900, 1020, and 1040 to correct typographical errors and to 
update addresses, office titles, and wording to ensure accuracy and 
clarity in the Agency's medical device regulations.
    FDA is making nonsubstantive changes to the following regulations:
    1. FDA is revising Sec.  890.5525(b)(2)(i)(A) by replacing 
``Testing using a drug approved for iontophoretic delivery, or a 
solution, if identified in the labeling, to demonstrate safe use of the 
device as intended'' with ``Testing using a drug approved for 
iontophoretic delivery, or a solution if identified in the labeling, to 
demonstrate safe use of the device as intended''.
    2. FDA is revising Sec.  900.3(b)(1) by replacing ``Division of 
Mammography Quality and Radiation Programs (DMQRP), Center for Devices 
and Radiology Health (HFZ-240), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, marked Attn: Mammography Standards 
Branch'' with ``Division of Mammography Quality Standards, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 4445, Silver Spring, MD 20993, Attn: 
Program Management Branch''.
    3. FDA is revising Sec.  900.11(b)(2)(i) by replacing ``42 U.S.C. 
263b(c)(2)'' with ``42 U.S.C. 263b(c)(4)''.
    4. FDA is revising Sec.  1020.30(c) by replacing ``Director of the 
Office of Communication, Education, and Radiation Programs of the 
Center for Devices and Radiological Health'' with ``Director, Center 
for Devices and Radiological Health''.
    5. FDA is revising Sec.  1040.10(a)(3)(i) by replacing ``Food and 
Drug Administration, Center for Devices and Radiological Health, 
Director, Office of Compliance, 10903 New Hampshire Ave., Bldg. 66, Rm. 
3521, Silver Spring, MD 20993-0002'' with ``Director, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002''.
    6. FDA is revising Sec.  1040.10(f)(6)(ii) by replacing ``Director, 
Office of

[[Page 13864]]

Compliance (HFZ-300), Center for Devices and Radiological Health'' with 
``Director, Center for Devices and Radiological Health''.
    7. FDA is revising Sec.  1040.10(g)(10) by replacing ``Director, 
Office of Compliance (HFZ-300), Center for Devices and Radiological 
Health'' with ``Director, Center for Devices and Radiological Health''.
    8. FDA is revising Sec.  1040.20(d)(3)(iii) by replacing 
``Director, Office of Communication, Education, and Radiation Programs 
10903 New Hampshire Ave., Bldg. 66, Rm. 4312, Silver Spring, MD 20993-
0002, Center for Devices and Radiological Health'' with ``Director, 
Center for Devices and Radiological Health''.
    9. FDA is revising Sec.  1040.20(d)(3)(iv) by replacing 
``manfacturer'' with ``manufacturer,'' and replacing ``Director, Office 
of Compliance (HFZ-300), Center for Devices and Radiological Health'' 
with ``Director, Center for Devices and Radiological Health''.

List of Subjects

21 CFR Part 890

    Medical devices, Physical medicine devices.

21 CFR Part 900

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

21 CFR Part 1020

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

21 CFR Part 1040

    Electronic funds transfers, Incorporation by reference, Labeling, 
Lasers, Medical devices, Radiation protection, Reporting and 
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
890, 900, 1020, and 1040 are amended as follows:

PART 890--PHYSICAL MEDICINE DEVICES

0
1. The authority citation for part 890 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Revise Sec.  890.5525(b)(2)(i)(A) to read as follows:


Sec.  890.5525   Iontophoresis device.

* * * * *
    (b) * * *
    (2) * * *
    (i) * * *
    (A) Testing using a drug approved for iontophoretic delivery, or a 
solution if identified in the labeling, to demonstrate safe use of the 
device as intended;
* * * * *

PART 900--MAMMOGRAPHY

0
3. The authority citation for part 900 continues to read as follows:

    Authority:  21 U.S.C. 360i, 360nn, 374(e), 42 U.S.C. 263b.


0
4. Revise Sec.  900.3(b)(1) to read as follows:


Sec.  900.3   Application for approval as an accreditation body.

* * * * *
    (b) * * *
    (1) An applicant seeking initial FDA approval as an accreditation 
body shall inform the Division of Mammography Quality Standards, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 4445, Silver Spring, MD 20993, 
Attn: Program Management Branch, of its desire to be approved as an 
accreditation body and of its requested scope of authority.
* * * * *

0
5. Revise Sec.  900.11(b)(2)(i) to read as follows:


Sec.  900.11   Requirements for certification.

* * * * *
    (b) * * *
    (2) * * *
    (i) A new facility beginning operation after October 1, 1994, is 
eligible to apply for a provisional certificate. The provisional 
certificate will enable the facility to perform mammography and to 
obtain the clinical images needed to complete the accreditation 
process. To apply for and receive a provisional certificate, a facility 
must meet the requirements of 42 U.S.C. 263b(c)(4) and submit the 
necessary information to an approved accreditation body or other entity 
designated by FDA.
* * * * *

PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING 
PRODUCTS

0
6. The authority citation for part 1020 continues to read as follows:

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


0
7. Revise Sec.  1020.30(c) to read as follows:


Sec.  1020.30   Diagnostic x-ray systems and their major components.

* * * * *
    (c) Manufacturers' responsibility. Manufacturers of products 
subject to Sec. Sec.  1020.30 through 1020.33 shall certify that each 
of their products meets all applicable requirements when installed into 
a diagnostic x-ray system according to instructions. This certification 
shall be made under the format specified in Sec.  1010.2 of this 
chapter. Manufacturers may certify a combination of two or more 
components if they obtain prior authorization in writing from the 
Director, Center for Devices and Radiological Health. Manufacturers 
shall not be held responsible for noncompliance of their products if 
that noncompliance is due solely to the improper installation or 
assembly of that product by another person; however, manufacturers are 
responsible for providing assembly instructions adequate to assure 
compliance of their components with the applicable provisions of 
Sec. Sec.  1020.30 through 1020.33.
* * * * *

PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

0
8. The authority citation for part 1040 continues to read as follows:

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


0
9. In Sec.  1040.10 revise paragraphs (a)(3)(i), (f)(6)(ii), and 
(g)(10) to read as follows:


Sec.  1040.10   Laser products.

    (a) * * *
    (3) * * *
    (i) Registers, and provides a listing by type of such laser 
products manufactured that includes the product name, model number, and 
laser medium or emitted wavelength(s), and the name and address of the 
manufacturer. The manufacturer must submit the registration and listing 
to the Director, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, 
MD 20993-0002.
* * * * *
    (f) * * *
    (6) * * *
    (ii) If the configuration, design, or function of the laser product 
would make unnecessary compliance with the requirement in paragraph 
(f)(6)(i) of this section, the Director, Center for Devices and 
Radiological Health, may, upon written application by the manufacturer, 
approve alternate means to accomplish

[[Page 13865]]

the radiation protection provided by the beam attenuator.
* * * * *
    (g) * * *
    (10) Label specifications. Labels required by this section and 
Sec.  1040.11 shall be permanently affixed to, or inscribed on, the 
laser product, legible, and clearly visible during operation, 
maintenance, or service, as appropriate. If the size, configuration, 
design, or function of the laser product would preclude compliance with 
the requirements for any required label or would render the required 
wording of such label inappropriate or ineffective, the Director, 
Center for Devices and Radiological Health, on the Director's own 
initiative or upon written application by the manufacturer, may approve 
alternate means of providing such label(s) or alternate wording for 
such label(s) as applicable.
* * * * *

0
10. In Sec.  1040.20 revise paragraphs (d)(3)(iii) and (iv) to read as 
follows:


Sec.  1040.20   Sunlamp products and ultraviolet lamps intended for use 
in sunlamp products.

* * * * *
    (d) * * *
    (3) * * *
    (iii) If the size, configuration, design, or function of the 
sunlamp product or ultraviolet lamp would preclude compliance with the 
requirements for any required label or would render the required 
wording of such label inappropriate or ineffective, or would render the 
required label unnecessary, the Director, Center for Devices and 
Radiological Health, on the center's own initiative or upon written 
application by the manufacturer, may approve alternate means of 
providing such label(s), alternate wording for such label(s), or 
deletion, as applicable.
    (iv) In lieu of permanently affixing or inscribing tags or labels 
on the ultraviolet lamp as required by Sec. Sec.  1010.2(b) and 
1010.3(a), the manufacturer of the ultraviolet lamp may permanently 
affix or inscribe such required tags or labels on the lamp packaging 
uniquely associated with the lamp, if the name of the manufacturer and 
month and year of manufacture are permanently affixed or inscribed on 
the exterior surface of the ultraviolet lamp so as to be legible and 
readily accessible to view. The name of the manufacturer and month and 
year of manufacture affixed or inscribed on the exterior surface of the 
lamp may be expressed in code or symbols, if the manufacturer has 
previously supplied the Director, Center for Devices and Radiological 
Health, with the key to such code or symbols and the location of the 
coded information or symbols on the ultraviolet lamp. The label or tag 
affixed or inscribed on the lamp packaging may provide either the month 
and year of manufacture without abbreviation, or information to allow 
the date to be readily decoded.
* * * * *

    Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06308 Filed 3-30-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations 13863 promulgate the body system listings Insurance, Reporting and recordkeeping and to ensure accuracy and clarity in again. Therefore, we have determined requirements, Social Security. the Agency’s regulations. that opportunity for prior comment is Nancy Berryhill, DATES: This rule is effective April 2, unnecessary, and we are issuing this 2018. Deputy Commissioner for Operations, regulation as a final rule. performing the duties and functions not FOR FURTHER INFORMATION CONTACT: In addition, for the reasons cited reserved to the Commissioner of Social Karen Fikes, Center for Devices and above, we find good cause for Security. Radiological Health, Food and Drug dispensing with the 30-day delay in the For the reasons set out in the Administration, 10903 New Hampshire effective date of this final rule. 5 U.S.C. preamble, we are amending appendix 1 Ave., Bldg. 66, Rm. 5244, Silver Spring, 553(d)(3). We are not making any to subpart P of part 404 of chapter III of MD 20993–0002, 301–796–9603. substantive changes to the listings in title 20 of the Code of Federal SUPPLEMENTARY INFORMATION: FDA is these body systems. Without an Regulations as set forth below. amending our regulations in 21 CFR extension of the expiration dates for parts 890, 900, 1020, and 1040 to correct PART 404—FEDERAL OLD-AGE, typographical errors and to update these listings, we will not have the SURVIVORS AND DISABILITY criteria we need to assess medical addresses, office titles, and wording to INSURANCE (1950–) ensure accuracy and clarity in the impairments in these two body systems at step three of the sequential evaluation Subpart P—[Amended] Agency’s medical device regulations. processes. We therefore find it is in the FDA is making nonsubstantive public interest to make this final rule ■ 1. The authority citation for subpart P changes to the following regulations: of part 404 continues to read as follows: 1. FDA is revising effective on the publication date. § 890.5525(b)(2)(i)(A) by replacing Authority: Secs. 202, 205(a)–(b) and (d)– ‘‘Testing using a drug approved for Executive Order 12866, as (h), 216(i), 221(a) and (h)-(j), 222(c), 223, 225, Supplemented by Executive Order and 702(a)(5) of the Social Security Act (42 iontophoretic delivery, or a solution, if 13563 U.S.C. 402, 405(a)–(b) and (d)–(h), 416(i), identified in the labeling, to 421(a) and (h)–(j), 422(c), 423, 425, and demonstrate safe use of the device as We consulted with the Office of 902(a)(5)); sec. 211(b), Pub. L. 104–193, 110 intended’’ with ‘‘Testing using a drug Management and Budget (OMB) and Stat. 2105, 2189; sec. 202, Pub. L. 108–203, approved for iontophoretic delivery, or determined that this final rule does not 118 Stat. 509 (42 U.S.C. 902 note). a solution if identified in the labeling, meet the requirements for a significant ■ 2. Amend appendix 1 to subpart P of to demonstrate safe use of the device as regulatory action under Executive Order part 404 by revising items 3 and 11 of intended’’. 12866, as supplemented by Executive the introductory text before Part A to 2. FDA is revising § 900.3(b)(1) by Order 13563. Therefore, OMB did not read as follows: replacing ‘‘Division of Mammography review it. We also determined that this Quality and Radiation Programs Appendix 1 to Subpart P of Part 404— (DMQRP), Center for Devices and final rule meets the plain language Listing of Impairments requirement of Executive Order 12866. Radiology Health (HFZ–240), Food and * * * * * Drug Administration, 1350 Piccard Dr., Regulatory Flexibility Act 3. Special Senses and Speech (2.00 and Rockville, MD 20850, marked Attn: 102.00): April 24, 2020. Mammography Standards Branch’’ with We certify that this final rule does not * * * * * ‘‘Division of Mammography Quality have a significant economic impact on 11. Congenital Disorders That Affect Standards, Center for Devices and a substantial number of small entities Multiple Body Systems (10.00 and 110.00): Radiological Health, Food and Drug because it affects only individuals. April 3, 2020. Administration, 10903 New Hampshire Therefore, a regulatory flexibility * * * * * Ave., Bldg. 66, Rm. 4445, Silver Spring, analysis is not required under the [FR Doc. 2018–06671 Filed 3–30–18; 8:45 am] MD 20993, Attn: Program Management Regulatory Flexibility Act, as amended. BILLING CODE 4191–02–P Branch’’. 3. FDA is revising § 900.11(b)(2)(i) by Paperwork Reduction Act replacing ‘‘42 U.S.C. 263b(c)(2)’’ with This final rule does not create any DEPARTMENT OF HEALTH AND ‘‘42 U.S.C. 263b(c)(4)’’. new or affect any existing collections HUMAN SERVICES 4. FDA is revising § 1020.30(c) by and, therefore, it does not require replacing ‘‘Director of the Office of OMB’s approval under the Paperwork Food and Drug Administration Communication, Education, and Radiation Programs of the Center for Reduction Act. 21 CFR Parts 890, 900, 1020, and 1040 Devices and Radiological Health’’ with (Catalog of Federal Domestic Assistance ‘‘Director, Center for Devices and Program Nos. 96.001, Social Security- [Docket No. FDA–2018–N–0011] Radiological Health’’. Disability Insurance; 96.002, Social Security- 5. FDA is revising § 1040.10(a)(3)(i) by Retirement Insurance; 96.004, Social Medical Devices; Technical Amendment replacing ‘‘Food and Drug Security-Survivors Insurance; 96.006, Administration, Center for Devices and Supplemental Security Income) AGENCY: Food and Drug Administration; Radiological Health, Director, Office of List of Subjects in 20 CFR Part 404 HHS. Compliance, 10903 New Hampshire Final rule; technical ACTION: Ave., Bldg. 66, Rm. 3521, Silver Spring, daltland on DSKBBV9HB2PROD with RULES Administrative practice and amendment. MD 20993–0002’’ with ‘‘Director, Center procedure, Blind, Disability benefits, for Devices and Radiological Health, Old-age, Survivors and Disability SUMMARY: The Food and Drug Food and Drug Administration, 10903 Administration (FDA or Agency) is New Hampshire Ave., Bldg. 66, Silver amending certain medical device Spring, MD 20993–0002’’. regulations. This action is editorial in 6. FDA is revising § 1040.10(f)(6)(ii) nature to correct typographical errors by replacing ‘‘Director, Office of VerDate Sep<11>2014 16:23 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 E:\FR\FM\02APR1.SGM 02APR1

13864 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations Compliance (HFZ–300), Center for § 890.5525 Iontophoresis device. § 1020.30 Diagnostic x-ray systems and Devices and Radiological Health’’ with * * * * * their major components. ‘‘Director, Center for Devices and (b) * * * * * * * * Radiological Health’’. (2) * * * (c) Manufacturers’ responsibility. 7. FDA is revising § 1040.10(g)(10) by (i) * * * Manufacturers of products subject to replacing ‘‘Director, Office of (A) Testing using a drug approved for §§ 1020.30 through 1020.33 shall certify Compliance (HFZ–300), Center for iontophoretic delivery, or a solution if that each of their products meets all Devices and Radiological Health’’ with identified in the labeling, to applicable requirements when installed ‘‘Director, Center for Devices and demonstrate safe use of the device as into a diagnostic x-ray system according Radiological Health’’. intended; to instructions. This certification shall 8. FDA is revising § 1040.20(d)(3)(iii) * * * * * be made under the format specified in by replacing ‘‘Director, Office of § 1010.2 of this chapter. Manufacturers PART 900—MAMMOGRAPHY may certify a combination of two or Communication, Education, and Radiation Programs 10903 New ■ 3. The authority citation for part 900 more components if they obtain prior Hampshire Ave., Bldg. 66, Rm. 4312, continues to read as follows: authorization in writing from the Silver Spring, MD 20993–0002, Center Director, Center for Devices and Authority: 21 U.S.C. 360i, 360nn, 374(e), Radiological Health. Manufacturers for Devices and Radiological Health’’ 42 U.S.C. 263b. with ‘‘Director, Center for Devices and shall not be held responsible for Radiological Health’’. ■ 4. Revise § 900.3(b)(1) to read as noncompliance of their products if that 9. FDA is revising § 1040.20(d)(3)(iv) follows: noncompliance is due solely to the by replacing ‘‘manfacturer’’ with improper installation or assembly of § 900.3 Application for approval as an ‘‘manufacturer,’’ and replacing accreditation body. that product by another person; ‘‘Director, Office of Compliance (HFZ– however, manufacturers are responsible * * * * * 300), Center for Devices and for providing assembly instructions (b) * * * Radiological Health’’ with ‘‘Director, (1) An applicant seeking initial FDA adequate to assure compliance of their Center for Devices and Radiological approval as an accreditation body shall components with the applicable Health’’. inform the Division of Mammography provisions of §§ 1020.30 through Quality Standards, Center for Devices 1020.33. List of Subjects * * * * * and Radiological Health, Food and Drug 21 CFR Part 890 Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4445, Silver Spring, PART 1040—PERFORMANCE Medical devices, Physical medicine STANDARDS FOR LIGHT-EMITTING MD 20993, Attn: Program Management devices. PRODUCTS Branch, of its desire to be approved as 21 CFR Part 900 an accreditation body and of its ■ 8. The authority citation for part 1040 requested scope of authority. Electronic products, Health facilities, continues to read as follows: Medical devices, Radiation protection, * * * * * Authority: 21 U.S.C. 351, 352, 360, 360e- Reporting and recordkeeping ■ 5. Revise § 900.11(b)(2)(i) to read as 360j, 360hh-360ss, 371, 381. requirements, X-rays. follows: ■ 9. In § 1040.10 revise paragraphs 21 CFR Part 1020 § 900.11 Requirements for certification. (a)(3)(i), (f)(6)(ii), and (g)(10) to read as Electronic products, Medical devices, * * * * * follows: (b) * * * Radiation protection, Reporting and (2) * * * § 1040.10 Laser products. recordkeeping requirements, Television, (i) A new facility beginning operation (a) * * * X-rays. after October 1, 1994, is eligible to apply (3) * * * 21 CFR Part 1040 for a provisional certificate. The (i) Registers, and provides a listing by provisional certificate will enable the type of such laser products Electronic funds transfers, facility to perform mammography and to manufactured that includes the product Incorporation by reference, Labeling, obtain the clinical images needed to name, model number, and laser medium Lasers, Medical devices, Radiation complete the accreditation process. To or emitted wavelength(s), and the name protection, Reporting and recordkeeping apply for and receive a provisional and address of the manufacturer. The requirements. certificate, a facility must meet the manufacturer must submit the Therefore, under the Federal Food, requirements of 42 U.S.C. 263b(c)(4) and registration and listing to the Director, Drug, and Cosmetic Act and under submit the necessary information to an Center for Devices and Radiological authority delegated to the Commissioner approved accreditation body or other Health, Food and Drug Administration, of Food and Drugs, 21 CFR parts 890, entity designated by FDA. 10903 New Hampshire Ave., Bldg. 66, 900, 1020, and 1040 are amended as * * * * * Silver Spring, MD 20993–0002. follows: * * * * * PART 1020—PERFORMANCE (f) * * * PART 890—PHYSICAL MEDICINE STANDARDS FOR IONIZING DEVICES (6) * * * RADIATION EMITTING PRODUCTS (ii) If the configuration, design, or function of the laser product would daltland on DSKBBV9HB2PROD with RULES ■ 1. The authority citation for part 890 ■ 6. The authority citation for part 1020 continues to read as follows: make unnecessary compliance with the continues to read as follows: requirement in paragraph (f)(6)(i) of this Authority: 21 U.S.C. 351, 360, 360c, 360e, Authority: 21 U.S.C. 351, 352, 360e–360j, section, the Director, Center for Devices 360j, 360l, 371. 360hh–360ss, 371, 381. and Radiological Health, may, upon ■ 2. Revise § 890.5525(b)(2)(i)(A) to read ■ 7. Revise § 1020.30(c) to read as written application by the manufacturer, as follows: follows: approve alternate means to accomplish VerDate Sep<11>2014 16:23 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 E:\FR\FM\02APR1.SGM 02APR1

Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations 13865 the radiation protection provided by the with the key to such code or symbols River, mile 3.0, has a vertical clearance beam attenuator. and the location of the coded in the closed position of 40 feet at mean * * * * * information or symbols on the high water and 45 feet at mean low (g) * * * ultraviolet lamp. The label or tag affixed water. The existing bridge operating (10) Label specifications. Labels or inscribed on the lamp packaging may regulations are listed at 33 CFR required by this section and § 1040.11 provide either the month and year of 117.723(b). shall be permanently affixed to, or manufacture without abbreviation, or Under this temporary deviation, the inscribed on, the laser product, legible, information to allow the date to be PATH Bridge shall remain in the closed and clearly visible during operation, readily decoded. position between 12:01 a.m. Saturday maintenance, or service, as appropriate. * * * * * and 12:01 a.m. Monday as follows: If the size, configuration, design, or Dated: March 22, 2018. March 31–April 2, 2018; April 7–9, 14– function of the laser product would 16, 21–23, and 28–30, 2018; May 5–7, Leslie Kux, preclude compliance with the 12–14, and 19–21, 2018; June 2–4, 9–11, Associate Commissioner for Policy. 16–18, 23–25, and 30-July 2, 2018; July requirements for any required label or [FR Doc. 2018–06308 Filed 3–30–18; 8:45 am] 7–9, 14–16, 21–23, and 28–30, 2018; would render the required wording of such label inappropriate or ineffective, BILLING CODE 4164–01–P August 4–6, 11–13, 18–20, and 25–27, the Director, Center for Devices and 2018; September 8–10, 15–17, 22–24, Radiological Health, on the Director’s 2018. own initiative or upon written DEPARTMENT OF HOMELAND The waterway is transited by application by the manufacturer, may SECURITY commercial and recreational traffic. The approve alternate means of providing Coast Guard notified known companies such label(s) or alternate wording for Coast Guard of the commercial vessels that transit such label(s) as applicable. the area, including the Sandy Hook 33 CFR Part 117 Pilots and the local Tug/Tow * * * * * [Docket No. USCG–2018–0110] Committee; there were no objections to ■ 10. In § 1040.20 revise paragraphs this temporary deviation. Vessels able to (d)(3)(iii) and (iv) to read as follows: Drawbridge Operation Regulation; pass under the bridge in the closed § 1040.20 Sunlamp products and Hackensack River, Jersey City, New position may do so at any time. The ultraviolet lamps intended for use in Jersey bridge will not be able to open for sunlamp products. emergencies and there is no immediate AGENCY: Coast Guard, DHS. * * * * * alternate route for vessels to pass. (d) * * * ACTION:Notice of deviation from The Coast Guard will inform the users (3) * * * drawbridge regulation. of the waterways through our Local and (iii) If the size, configuration, design, SUMMARY: The Coast Guard has issued a Broadcast Notices to Mariners of the or function of the sunlamp product or temporary deviation from the operating change in operating schedule for the ultraviolet lamp would preclude schedule that governs the PATH Bridge bridge so that vessel operations can compliance with the requirements for across the Hackensack River, mile 3.0, at arrange their transits to minimize any any required label or would render the Jersey City, New Jersey. This temporary impact caused by the temporary required wording of such label deviation is necessary to allow the deviation. inappropriate or ineffective, or would bridge to remain in the closed-to- In accordance with 33 CFR 117.35(e), render the required label unnecessary, navigation position to facilitate the the drawbridge must return to its regular the Director, Center for Devices and replacement of rails and timbers across operating schedule immediately at the Radiological Health, on the center’s own the length of the span of the bridge. end of the effective period of this initiative or upon written application by temporary deviation. This deviation DATES: This deviation is effective from the manufacturer, may approve alternate from the operating regulations is 12:01 a.m. on March 31, 2018, to 12:01 means of providing such label(s), authorized under 33 CFR 117.35. a.m. on September 26, 2018. alternate wording for such label(s), or Dated: March 27, 2018. deletion, as applicable. ADDRESSES: The docket for this deviation, USCG–2018–0110 is available Christopher J. Bisignano, (iv) In lieu of permanently affixing or inscribing tags or labels on the at http://www.regulations.gov. Type the Supervisory Bridge Management Specialist, docket number in the ‘‘SEARCH’’ box First Coast Guard District. ultraviolet lamp as required by §§ 1010.2(b) and 1010.3(a), the and click ‘‘SEARCH.’’ Click on Open [FR Doc. 2018–06540 Filed 3–30–18; 8:45 am] manufacturer of the ultraviolet lamp Docket Folder on the line associated BILLING CODE 9110–04–P may permanently affix or inscribe such with this deviation. required tags or labels on the lamp FOR FURTHER INFORMATION CONTACT: If you have questions on this temporary DEPARTMENT OF HOMELAND packaging uniquely associated with the deviation, call or email Judy Leung-Yee, SECURITY lamp, if the name of the manufacturer and month and year of manufacture are Project Officer, First Coast Guard Coast Guard permanently affixed or inscribed on the District, telephone 212–514–4330, email exterior surface of the ultraviolet lamp Judy.K.Leung-yee@uscg.mil. 33 CFR Part 117 so as to be legible and readily accessible SUPPLEMENTARY INFORMATION: The Port to view. The name of the manufacturer Authority Trans-Hudson Corporation, daltland on DSKBBV9HB2PROD with RULES [Docket No. USCG–2018–0253] and month and year of manufacture the owner of the bridge, requested a affixed or inscribed on the exterior temporary deviation from the normal Drawbridge Operation Regulation; surface of the lamp may be expressed in operating schedule to facilitate the Lake Washington Ship Canal, Seattle, code or symbols, if the manufacturer has replacement of rails and timbers across WA previously supplied the Director, Center the length of the span of the bridge. The for Devices and Radiological Health, PATH Bridge across the Hackensack AGENCY: Coast Guard, DHS. VerDate Sep<11>2014 16:23 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\FR\FM\02APR1.SGM 02APR1


Document Created: 2018-11-01 09:08:54
Document Modified: 2018-11-01 09:08:54
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; technical amendment.
DatesThis rule is effective April 2, 2018.
ContactKaren Fikes, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993-0002, 301-796-9603.
FR Citation83 FR 13863 
CFR Citation21 CFR 1020
21 CFR 1040
21 CFR 890
21 CFR 900
CFR AssociatedTelevision; Electronic Funds Transfers; Incorporation by Reference; Labeling; Lasers; Medical Devices; Physical Medicine Devices; Electronic Products; Health Facilities; Radiation Protection; Reporting and Recordkeeping Requirements and X-Rays
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR