Medical Device Classification Procedures; Change of Address; Technical Amendment, 39534-39535 [2017-17564]

Download as PDF sradovich on DSK3GMQ082PROD with RULES 39534 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Rules and Regulations ending June 30, 2008. The Act also states that any increase shall be rounded to the nearest dollar and that there shall be no increase in the dollar amounts if the change in the CPI is less than one percent. For fiscal year 2009, the Act specified that the original annual fee for access to the Registry for each area code of data was $54 per area code, or $27 per area code of data during the second six months of an entity’s annual subscription period, and that the maximum amount that would be charged to any single entity for accessing area codes of data would be $14,850. The determination whether a fee change is required and the amount of the fee change involves a two-step process. First, to determine whether a fee change is required, we measure the change in the CPI from the time of the previous increase in fees. There was an increase in the fees for fiscal year 2017. Accordingly, we calculated the change in the CPI since last year, and the increase was 1.84 percent. Because this change is over the one percent threshold, the fees will change for fiscal year 2018. Second, to determine how much the fees should increase this fiscal year, we use the calculation specified by the Act set forth above, the percentage change in the baseline CPI applied to the original fees for fiscal year 2009. The average value of the CPI for July 1, 2007 to June 30, 2008 was 211.702; the average value for July 1, 2016 to June 30, 2017 was 242.656, an increase of 14.62 percent. Applying the 14.62 percent increase to the base amount from fiscal year 2009, leads to an increase from $61 to $62 in the fee from last year for access to a single area code of data for a full year for fiscal year 2018. The actual amount is $61.89, but when rounded, pursuant to the Act, the amount is $62. The fee for accessing an additional area code for a half year increases from $30 to $31 (rounded from $30.95). The maximum amount charged increases to $17,021 (rounded from $17,021.07). Administrative Procedure Act; Regulatory Flexibility Act; Paperwork Reduction Act. The revisions to the Fee Rule are technical in nature and merely incorporate statutory changes to the TSR. These statutory changes have been adopted without change or interpretation, making public comment unnecessary. Therefore, the Commission has determined that the notice and comment requirements of the Administrative Procedure Act do not apply. See 5 U.S.C. 553(b). For this reason, the requirements of the Regulatory Flexibility Act also do not apply. See 5 U.S.C. 603, 604. VerDate Sep<11>2014 16:12 Aug 18, 2017 Jkt 241001 Pursuant to the Paperwork Reduction Act, 44 U.S.C. 3501–3521, the Office of Management and Budget (‘‘OMB’’) approved the information collection requirements in the Amended TSR and assigned the following existing OMB Control Number: 3084–0097. The amendments outlined in this Final Rule pertain only to the fee provision (§ 310.8) of the Amended TSR and will not establish or alter any record keeping, reporting, or third-party disclosure requirements elsewhere in the Amended TSR. List of Subjects in 16 CFR Part 310 Advertising, Consumer protection, Reporting and recordkeeping requirements, Telephone, Trade practices. Accordingly, the Federal Trade Commission amends part 310 of title 16 of the Code of Federal Regulations as follows: PART 310—TELEMARKETING SALES RULE 1. The authority citation for part 310 continues to read as follows: ■ Authority: 15 U.S.C. 6101–6108; 15 U.S.C. 6151–6155. 2. In § 310.8, revise paragraphs (c) and (d) to read as follows: ■ § 310.8 Fee for access to the National Do Not Call Registry. * * * * * (c) The annual fee, which must be paid by any person prior to obtaining access to the National Do Not Call Registry, is $62 for each area code of data accessed, up to a maximum of $17,021; provided, however, that there shall be no charge to any person for accessing the first five area codes of data, and provided further, that there shall be no charge to any person engaging in or causing others to engage in outbound telephone calls to consumers and who is accessing area codes of data in the National Do Not Call Registry if the person is permitted to access, but is not required to access, the National Do Not Call Registry under this Rule, 47 CFR 64.1200, or any other Federal regulation or law. No person may participate in any arrangement to share the cost of accessing the National Do Not Call Registry, including any arrangement with any telemarketer or service provider to divide the costs to access the registry among various clients of that telemarketer or service provider. (d) Each person who pays, either directly or through another person, the annual fee set forth in paragraph (c) of this section, each person excepted under paragraph (c) from paying the PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 annual fee, and each person excepted from paying an annual fee under § 310.4(b)(1)(iii)(B), will be provided a unique account number that will allow that person to access the registry data for the selected area codes at any time for the twelve month period beginning on the first day of the month in which the person paid the fee (‘‘the annual period’’). To obtain access to additional area codes of data during the first six months of the annual period, each person required to pay the fee under paragraph (c) of this section must first pay $62 for each additional area code of data not initially selected. To obtain access to additional area codes of data during the second six months of the annual period, each person required to pay the fee under paragraph (c) of this section must first pay $31 for each additional area code of data not initially selected. The payment of the additional fee will permit the person to access the additional area codes of data for the remainder of the annual period. * * * * * By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2017–17437 Filed 8–18–17; 8:45 am] BILLING CODE 6750–01–P 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. Final rule; technical amendment. ACTION: 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. SUMMARY: E:\FR\FM\21AUR1.SGM 21AUR1 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Rules and Regulations FDA is amending our regulations in 21 CFR part 860 that set forth procedures for mailing reclassification petitions (§ 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 § 860.123(b)(1) for devices regulated by CDRH. The address for submitting a reclassification petition for devices regulated by CDRH in § 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. SUPPLEMENTARY INFORMATION: 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 1. The authority citation for part 860 continues to read as follows: ■ Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374. 2. Revise § 860.123(b)(1) to read as follows: sradovich on DSK3GMQ082PROD with RULES ■ § 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, VerDate Sep<11>2014 16:12 Aug 18, 2017 Jkt 241001 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 DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG–2017–0699] RIN 1625–AA00 Safety Zone: PG&E Evolution, King Salmon, CA Coast Guard, DHS. Temporary final rule. AGENCY: ACTION: The Coast Guard is establishing a temporary safety zone in the navigable waters of Humboldt Bay in King Salmon, CA in support of the Pacific Gas and Electric Evolution that will be effective on August 2, 2017 and on August 30, 2017. This safety zone is established to ensure the safety of workers, mariners, and other vessels transiting the area from the dangers associated with this evolution. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zone without permission of the Captain of the Port or their designated representative. DATES: This rule is effective without actual notice from August 21, 2017 until August 30, 2017. For the purposes of enforcement, actual notice will be used from August 2, 2017, until August 21, 2017. This rule is being enforced from 8 a.m. to 4 p.m. on August 2, 2017 and from 8 a.m. to 4 p.m. on August 30, 2017. SUMMARY: PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 39535 Documents mentioned in this preamble are part of docket USCG– 2017–0699. To view these documents go to https://www.regulations.gov, type the docket number in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on Open Docket Folder on the line associated with this rulemaking. FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call or email Lieutenant Marcia Medina, U.S. Coast Guard Sector San Francisco; telephone (415) 399–7443 or email at D11-PF-MarineEvents@uscg.mil. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Table of Abbreviations APA Administrative Procedures Act CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security FR Federal Register NAD North American Datum of 1983 NPRM Notice of Proposed Rulemaking PG&E Pacific Gas & Electric § Section U.S.C. United States Code II. Background Information and Regulatory History The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are ‘‘impracticable, unnecessary, or contrary to the public interest.’’ Due to the date of the event, notice and comment procedures would be impracticable in this instance. For similar reasons as those stated above, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. III. Legal Authority and Need for Rule The legal basis for the proposed rule is 33 U.S.C 1231; 50 U.S.C. 191; 33 CFR 1.05–1, 6.04–1, 6.04–6, 160.5; Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish safety zones. The Pacific Gas and Electric Company will sponsor the Pacific Gas and Electric Evolution on August 2, 2017 and on August 30, 2017, in the navigable waters of Humboldt Bay in King Salmon, CA. The evolution is necessary to complete an inspection and for re-licensing purposes. The evolution is scheduled to take place on August 2, 2017 and on E:\FR\FM\21AUR1.SGM 21AUR1

Agencies

[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Rules and Regulations]
[Pages 39534-39535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17564]


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

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.

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

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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.