82_FR_39694 82 FR 39534 - Medical Device Classification Procedures; Change of Address; Technical Amendment

82 FR 39534 - Medical Device Classification Procedures; Change of Address; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 160 (August 21, 2017)

Page Range39534-39535
FR Document2017-17564

The Food and Drug Administration (FDA or Agency) is amending the Medical Device Classification Procedures regulation to reflect a change in address for the Center for Devices and Radiological Health (CDRH). This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

Federal Register, Volume 82 Issue 160 (Monday, August 21, 2017) 
[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Rules and Regulations]
[Pages 39534-39535]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-17564]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 860

[Docket No. FDA-2013-N-1529]


Medical Device Classification Procedures; Change of Address; 
Technical Amendment

AGENCY: Food and Drug Administration; HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is amending 
the Medical Device Classification Procedures regulation to reflect a 
change in address for the Center for Devices and Radiological Health 
(CDRH). This action is editorial in nature and is intended to improve 
the accuracy of the Agency's regulations.

DATES: This rule is effective August 21, 2017.

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.

[[Page 39535]]


SUPPLEMENTARY INFORMATION: FDA is amending our regulations in 21 CFR 
part 860 that set forth procedures for mailing reclassification 
petitions (Sec.  860.123 (21 CFR 860.123)) to revise the mailing 
address for CDRH. The current mailing address in the regulation for 
CDRH is as follows: Center for Devices and Radiological Health, 
Regulations Staff, 10903 New Hampshire Ave., Bldg. 66, Rm. 4438, Silver 
Spring, MD 20993-0002. The room number, 4438, has been changed; the new 
room number is G609. The mailing address is revised as follows: Center 
for Devices and Radiological Health, Regulations Staff, Document Mail 
Center-WO66-G609, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002.
    Sections 513(e) and (f), 514(b), 515(b), and 520(l) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(e) and (f); 
360d(b); 360e(b), and 360j(l)), provide for the reclassification of a 
device and prescribe procedures to petition for reclassification. FDA 
provides procedures for the content and form of reclassification 
petitions submitted pursuant to Sec.  860.123(b)(1) for devices 
regulated by CDRH. The address for submitting a reclassification 
petition for devices regulated by CDRH in Sec.  860.123(b)(1) is 
amended to reflect the new room number. The addresses remain the same 
for the Center for Biologics Evaluation and Research and the Center for 
Drug Evaluation and Research.

List of Subjects in 21 CFR Part 860

    Administrative practice and procedure, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
860 is amended as follows:

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

0
1. The authority citation for part 860 continues to read as follows:

    Authority:  21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.

0
2. Revise Sec.  860.123(b)(1) to read as follows:


Sec.  860.123   Reclassification petition: Content and form.

* * * * *
    (b) * * *
    (1) For devices regulated by the Center for Devices and 
Radiological Health, addressed to the Food and Drug Administration, 
Center for Devices and Radiological Health, Regulations Staff, Document 
Mail Center-WO66-G609, 10903 New Hampshire Ave., Silver Spring, MD 
20993-0002; for devices regulated by the Center for Biologics 
Evaluation and Research, addressed to the Food and Drug Administration, 
Center for Biologics Evaluation and Research, Document Control Center, 
10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-
0002; for devices regulated by the Center for Drug Evaluation and 
Research, addressed to the Food and Drug Administration, Center for 
Drug Evaluation and Research, Central Document Control Room, 5901-B 
Ammendale Rd., Beltsville, MD 20705-1266, as applicable.
* * * * *

    Dated: August 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17564 Filed 8-18-17; 8:45 am]
 BILLING CODE 4164-01-P

39534 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Rules and Regulations ending June 30, 2008. The Act also Pursuant to the Paperwork Reduction annual fee, and each person excepted states that any increase shall be rounded Act, 44 U.S.C. 3501–3521, the Office of from paying an annual fee under to the nearest dollar and that there shall Management and Budget (‘‘OMB’’) § 310.4(b)(1)(iii)(B), will be provided a be no increase in the dollar amounts if approved the information collection unique account number that will allow the change in the CPI is less than one requirements in the Amended TSR and that person to access the registry data percent. For fiscal year 2009, the Act assigned the following existing OMB for the selected area codes at any time specified that the original annual fee for Control Number: 3084–0097. The for the twelve month period beginning access to the Registry for each area code amendments outlined in this Final Rule on the first day of the month in which of data was $54 per area code, or $27 pertain only to the fee provision the person paid the fee (‘‘the annual per area code of data during the second (§ 310.8) of the Amended TSR and will period’’). To obtain access to additional six months of an entity’s annual not establish or alter any record area codes of data during the first six subscription period, and that the keeping, reporting, or third-party months of the annual period, each maximum amount that would be disclosure requirements elsewhere in person required to pay the fee under charged to any single entity for the Amended TSR. paragraph (c) of this section must first accessing area codes of data would be pay $62 for each additional area code of List of Subjects in 16 CFR Part 310 $14,850. data not initially selected. To obtain The determination whether a fee Advertising, Consumer protection, access to additional area codes of data change is required and the amount of Reporting and recordkeeping during the second six months of the the fee change involves a two-step requirements, Telephone, Trade annual period, each person required to process. First, to determine whether a practices. pay the fee under paragraph (c) of this fee change is required, we measure the Accordingly, the Federal Trade section must first pay $31 for each change in the CPI from the time of the Commission amends part 310 of title 16 additional area code of data not initially previous increase in fees. There was an of the Code of Federal Regulations as selected. The payment of the additional increase in the fees for fiscal year 2017. follows: fee will permit the person to access the Accordingly, we calculated the change additional area codes of data for the in the CPI since last year, and the PART 310—TELEMARKETING SALES remainder of the annual period. increase was 1.84 percent. Because this RULE * * * * * change is over the one percent threshold, the fees will change for fiscal ■ 1. The authority citation for part 310 By direction of the Commission. year 2018. continues to read as follows: Donald S. Clark, Second, to determine how much the Authority: 15 U.S.C. 6101–6108; 15 U.S.C. Secretary. fees should increase this fiscal year, we 6151–6155. [FR Doc. 2017–17437 Filed 8–18–17; 8:45 am] use the calculation specified by the Act ■ 2. In § 310.8, revise paragraphs (c) and BILLING CODE 6750–01–P set forth above, the percentage change in (d) to read as follows: the baseline CPI applied to the original fees for fiscal year 2009. The average § 310.8 Fee for access to the National Do DEPARTMENT OF HEALTH AND value of the CPI for July 1, 2007 to June Not Call Registry. HUMAN SERVICES 30, 2008 was 211.702; the average value * * * * * for July 1, 2016 to June 30, 2017 was (c) The annual fee, which must be Food and Drug Administration 242.656, an increase of 14.62 percent. paid by any person prior to obtaining Applying the 14.62 percent increase to access to the National Do Not Call 21 CFR Part 860 the base amount from fiscal year 2009, Registry, is $62 for each area code of data accessed, up to a maximum of [Docket No. FDA–2013–N–1529] leads to an increase from $61 to $62 in the fee from last year for access to a $17,021; provided, however, that there Medical Device Classification single area code of data for a full year shall be no charge to any person for Procedures; Change of Address; for fiscal year 2018. The actual amount accessing the first five area codes of Technical Amendment is $61.89, but when rounded, pursuant data, and provided further, that there to the Act, the amount is $62. The fee shall be no charge to any person AGENCY: Food and Drug Administration; for accessing an additional area code for engaging in or causing others to engage HHS. a half year increases from $30 to $31 in outbound telephone calls to Final rule; technical ACTION: (rounded from $30.95). The maximum consumers and who is accessing area amendment. amount charged increases to $17,021 codes of data in the National Do Not (rounded from $17,021.07). Call Registry if the person is permitted SUMMARY: The Food and Drug Administrative Procedure Act; to access, but is not required to access, Administration (FDA or Agency) is Regulatory Flexibility Act; Paperwork the National Do Not Call Registry under amending the Medical Device Reduction Act. The revisions to the Fee this Rule, 47 CFR 64.1200, or any other Classification Procedures regulation to Rule are technical in nature and merely Federal regulation or law. No person reflect a change in address for the incorporate statutory changes to the may participate in any arrangement to Center for Devices and Radiological TSR. These statutory changes have been share the cost of accessing the National Health (CDRH). This action is editorial adopted without change or Do Not Call Registry, including any in nature and is intended to improve the interpretation, making public comment arrangement with any telemarketer or accuracy of the Agency’s regulations. unnecessary. Therefore, the Commission service provider to divide the costs to DATES: This rule is effective August 21, sradovich on DSK3GMQ082PROD with RULES has determined that the notice and access the registry among various clients 2017. comment requirements of the of that telemarketer or service provider. FOR FURTHER INFORMATION CONTACT: Administrative Procedure Act do not (d) Each person who pays, either Karen Fikes, Center for Devices and apply. See 5 U.S.C. 553(b). For this directly or through another person, the Radiological Health, Food and Drug reason, the requirements of the annual fee set forth in paragraph (c) of Administration, 10903 New Hampshire Regulatory Flexibility Act also do not this section, each person excepted Ave., Bldg. 66, Rm. 5244, Silver Spring, apply. See 5 U.S.C. 603, 604. under paragraph (c) from paying the MD 20993–0002, 301–796–9603. VerDate Sep<11>2014 16:12 Aug 18, 2017 Jkt 241001 PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 E:\FR\FM\21AUR1.SGM 21AUR1

Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Rules and Regulations 39535 SUPPLEMENTARY INFORMATION: FDA is Document Mail Center–WO66–G609, ADDRESSES: Documents mentioned in amending our regulations in 21 CFR 10903 New Hampshire Ave., Silver this preamble are part of docket USCG– part 860 that set forth procedures for Spring, MD 20993–0002; for devices 2017–0699. To view these documents go mailing reclassification petitions regulated by the Center for Biologics to http://www.regulations.gov, type the (§ 860.123 (21 CFR 860.123)) to revise Evaluation and Research, addressed to docket number in the ‘‘SEARCH’’ box the mailing address for CDRH. The the Food and Drug Administration, and click ‘‘SEARCH.’’ Click on Open current mailing address in the Center for Biologics Evaluation and Docket Folder on the line associated regulation for CDRH is as follows: Research, Document Control Center, with this rulemaking. Center for Devices and Radiological 10903 New Hampshire Ave., Bldg. 71, FOR FURTHER INFORMATION CONTACT: If Health, Regulations Staff, 10903 New Rm. G112, Silver Spring, MD 20993– you have questions on this rule, call or Hampshire Ave., Bldg. 66, Rm. 4438, 0002; for devices regulated by the email Lieutenant Marcia Medina, U.S. Silver Spring, MD 20993–0002. The Center for Drug Evaluation and Coast Guard Sector San Francisco; room number, 4438, has been changed; Research, addressed to the Food and telephone (415) 399–7443 or email at the new room number is G609. The Drug Administration, Center for Drug D11-PF-MarineEvents@uscg.mil. mailing address is revised as follows: Evaluation and Research, Central SUPPLEMENTARY INFORMATION: Center for Devices and Radiological Document Control Room, 5901–B Health, Regulations Staff, Document Ammendale Rd., Beltsville, MD 20705– I. Table of Abbreviations Mail Center–WO66–G609, 10903 New 1266, as applicable. APA Administrative Procedures Act Hampshire Ave., Silver Spring, MD * * * * * CFR Code of Federal Regulations 20993–0002. COTP Captain of the Port Dated: August 15, 2017. Sections 513(e) and (f), 514(b), 515(b), DHS Department of Homeland Security and 520(l) of the Federal Food, Drug, Leslie Kux, FR Federal Register and Cosmetic Act (the FD&C Act) (21 Associate Commissioner for Policy. NAD North American Datum of 1983 U.S.C. 360c(e) and (f); 360d(b); 360e(b), [FR Doc. 2017–17564 Filed 8–18–17; 8:45 am] NPRM Notice of Proposed Rulemaking and 360j(l)), provide for the BILLING CODE 4164–01–P PG&E Pacific Gas & Electric § Section reclassification of a device and prescribe U.S.C. United States Code procedures to petition for reclassification. FDA provides DEPARTMENT OF HOMELAND II. Background Information and procedures for the content and form of SECURITY Regulatory History reclassification petitions submitted The Coast Guard is issuing this pursuant to § 860.123(b)(1) for devices Coast Guard temporary final rule without prior regulated by CDRH. The address for notice and opportunity to comment submitting a reclassification petition for 33 CFR Part 165 pursuant to authority under section 4(a) devices regulated by CDRH in [Docket No. USCG–2017–0699] of the Administrative Procedure Act § 860.123(b)(1) is amended to reflect the (APA) (5 U.S.C. 553(b)). This provision new room number. The addresses RIN 1625–AA00 authorizes an agency to issue a rule remain the same for the Center for without prior notice and opportunity to Biologics Evaluation and Research and Safety Zone: PG&E Evolution, King Salmon, CA comment when the agency for good the Center for Drug Evaluation and cause finds that those procedures are Research. AGENCY: Coast Guard, DHS. ‘‘impracticable, unnecessary, or contrary List of Subjects in 21 CFR Part 860 ACTION: Temporary final rule. to the public interest.’’ Due to the date Administrative practice and of the event, notice and comment SUMMARY: The Coast Guard is procedures would be impracticable in procedure, Medical devices. establishing a temporary safety zone in this instance. Therefore, under the Federal Food, the navigable waters of Humboldt Bay For similar reasons as those stated Drug, and Cosmetic Act and under in King Salmon, CA in support of the above, under 5 U.S.C. 553(d)(3), the authority delegated to the Commissioner Pacific Gas and Electric Evolution that Coast Guard finds that good cause exists of Food and Drugs, 21 CFR part 860 is will be effective on August 2, 2017 and for making this rule effective less than amended as follows: on August 30, 2017. This safety zone is 30 days after publication in the Federal established to ensure the safety of Register. PART 860—MEDICAL DEVICE workers, mariners, and other vessels CLASSIFICATION PROCEDURES transiting the area from the dangers III. Legal Authority and Need for Rule ■ 1. The authority citation for part 860 associated with this evolution. The legal basis for the proposed rule continues to read as follows: Unauthorized persons or vessels are is 33 U.S.C 1231; 50 U.S.C. 191; 33 CFR prohibited from entering into, transiting 1.05–1, 6.04–1, 6.04–6, 160.5; Authority: 21 U.S.C. 360c, 360d, 360e, through, or remaining in the safety zone 360i, 360j, 371, 374. Department of Homeland Security without permission of the Captain of the Delegation No. 0170.1, which ■ 2. Revise § 860.123(b)(1) to read as Port or their designated representative. collectively authorize the Coast Guard follows: DATES: This rule is effective without to establish safety zones. § 860.123 Reclassification petition: actual notice from August 21, 2017 until The Pacific Gas and Electric Company Content and form. August 30, 2017. For the purposes of will sponsor the Pacific Gas and Electric sradovich on DSK3GMQ082PROD with RULES * * * * * enforcement, actual notice will be used Evolution on August 2, 2017 and on (b) * * * from August 2, 2017, until August 21, August 30, 2017, in the navigable waters (1) For devices regulated by the 2017. of Humboldt Bay in King Salmon, CA. Center for Devices and Radiological This rule is being enforced from 8 The evolution is necessary to complete Health, addressed to the Food and Drug a.m. to 4 p.m. on August 2, 2017 and an inspection and for re-licensing Administration, Center for Devices and from 8 a.m. to 4 p.m. on August 30, purposes. The evolution is scheduled to Radiological Health, Regulations Staff, 2017. take place on August 2, 2017 and on VerDate Sep<11>2014 16:12 Aug 18, 2017 Jkt 241001 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 E:\FR\FM\21AUR1.SGM 21AUR1


Document Created: 2017-08-19 00:44:53
Document Modified: 2017-08-19 00:44:53
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 August 21, 2017<INF>.</INF>
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 Citation82 FR 39534 
CFR AssociatedAdministrative Practice and Procedure and Medical Devices
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