35658 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 

notifies blood establishments that 

collect blood and blood components 

that we have determined babesiosis to 

be an RTTI under 21 CFR 630.3(h)(2) 

and provides recommendations for 

donor screening, donation testing, donor 

deferral, and product management to 

reduce the risk of TTB. The 

recommendations contained in the draft 

guidance document applies to the 

collection of blood and blood 

components, except Source Plasma. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on recommendations for reducing the 

risk of transfusion-transmitted 

babesiosis. It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. This guidance is not 

subject to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 601 have been approved 

under OMB control number 0910–0338, 

and the collections of information in 21 

CFR part 606, 21 CFR 610.40(h), and 21 

CFR 630.40 have been approved under 

OMB control number 0910–0116. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or https://

www.regulations.gov. 

Dated: July 20, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16030 Filed 7–26–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2494] 

Peripheral Vascular Atherectomy 

Devices—Premarket Notification 

Submissions; Draft Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Peripheral Vascular 

Atherectomy Devices—Premarket 

Notification [510(k)] Submissions.’’ This 

draft guidance provides 

recommendations for premarket 

submissions for a new or modified 

peripheral vascular atherectomy device. 

This draft guidance is not final nor is it 

in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 25, 2018 to ensure that 

the Agency considers your comment on 

this draft guidance before it begins work 

on the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–D–2494 for ‘‘Peripheral Vascular 

Atherectomy Devices—Premarket 

Notification [510(k)] Submissions.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https:// 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35659 

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Peripheral Vascular 

Atherectomy Devices—Premarket 

Notification [510(k)] Submissions’’ to 

the Office of the Center Director, 

Guidance and Policy Development, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request. 

FOR FURTHER INFORMATION CONTACT: 

Misti Malone, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 120, Silver Spring, 

MD 20993–0002, 301–796–2520. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Atherectomy is an interventional 

procedure performed to debulk 

atherosclerotic plaque from diseased 

arteries. Atherectomy has been used in 

treatment of both coronary and 

peripheral arterial disease. FDA has 

developed this draft guidance for 

members of industry who submit and 

FDA staff who review premarket 

submissions for atherectomy devices 

used in the peripheral vasculature. 

When finalized, this guidance is 

intended to provide recommendations 

for information to include in premarket 

notifications (510(k)) for peripheral 

vascular atherectomy devices (e.g., 

descriptive characteristics, labeling, 

biocompatibility, sterility, non-clinical, 

animal, and clinical performance 

testing). 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Peripheral Vascular Atherectomy 

Devices—Premarket Notification 

[510(k)] Submissions.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. This 

guidance document is also available at 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Peripheral Vascular Atherectomy 

Devices—Premarket Notification 

[510(k)] Submissions’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 16013 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in the following FDA 

regulations and guidance have been 

approved by OMB as listed in the 

following table: 

21 CFR part Topic OMB Control 

No. 

807, subpart E .......................................... Premarket Notification .................................................................................................. 0910–0120 

812 ............................................................ Investigational Device Exemption ................................................................................ 0910–0078 

820 ............................................................ Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ..... 0910–0073 

807, subparts A through D ....................... Electronic Submission of Medical Device Registration and Listing ............................. 0910–0625 

50, 56 ........................................................ Protection of Human Subjects: Informed Consent; Institutional Review Boards ........ 0910–0755 

56 .............................................................. Institutional Review Boards .......................................................................................... 0910–0130 

58 .............................................................. Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies ..... 0910–0119 

801.150(a)(2) and (e) ............................... Agreement for Shipments of Devices for Sterilization ................................................. 0910–0131 

Dated: July 20, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16029 Filed 7–26–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2775] 

Food Safety Modernization Act 

Domestic and Foreign Facility 

Reinspection, Recall, and Importer 

Reinspection Fee Rates for Fiscal Year 

2019 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

fiscal year (FY) 2019 fee rates for certain 

domestic and foreign facility 

reinspections, failures to comply with a 

recall order, and importer reinspections 

that are authorized by the Federal Food, 

Drug, and Cosmetic Act (FD&C Act), as 

amended by the FDA Food Safety 

Modernization Act (FSMA). These fees 

are effective on October 1, 2018, and 

will remain in effect through September 

30, 2019. 

FOR FURTHER INFORMATION CONTACT: 

Jason Lewis, Office of Management, 

Office of Regulatory Affairs, Food and 

Drug Administration, 12420 Parklawn 

Dr., Rm. 2406, Rockville, MD 20857, 


amozie on DSK3GDR082PROD with NOTICES1