27996 Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices 

total estimated hour burden per 

respondent for the proposed DD Council 

PPR will increase from the 138 hours 

estimated in 2015 to 172 burden hours 

per response. The number of hours is 

multiplied by 56 State Council 

programs, resulting in a total estimated 

hour aggregate burden of 9,632. 

Respondent/data 

collection activity 

Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Annual 

burden hours 

State Councils on ............................................................................................

Developmental Disabilities/Program Performance Report .............................. 56 1 172 9632 

Total .......................................................................................................... 56 1 172 9632 

Dated: June 7, 2018. 

Lance Robertson, 

Administrator and Assistant Secretary for 

Aging. 

[FR Doc. 2018–12826 Filed 6–14–18; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Notice of Intent To Award a SingleSource Supplement 

ACTION: Intent To Award a SingleSource Supplement for the Amputee 

Coalition of America, Inc. for the 

National Limb Loss Resource Center 

Cooperative Agreement. 

The Administration for Community 

Living (ACL) announces the intent to 

award a single-source supplement to the 

current cooperative agreement held by 

the Amputee Coalition of America, Inc. 

for the National Limb Loss Resource 

Center (NLLRC). The purpose of this 

project is to expand on current grant 

activities, such as increasing activities 

and programs that promote health, 

wellness, and the adoption of healthy 

behaviors with the objective of 

preventing and/or reducing chronic 

conditions associated with limb loss 

and increase partnerships and 

collaborations with ACL programs that 

will benefit all people living with limb 

loss or limb differences. The 

administrative supplement for FY 2018 

will be in the amount of $669,905, 

bringing the total award for FY 2018 to 

$3,697,142. 

The additional funding will not be 

used to begin new projects. The funding 

will be used to enhance and expand 

existing programs that can serve an 

increased number of veterans and 

people living with limb loss and limb 

differences by providing increased 

technical assistance activities; 

promoting health and wellness 

programs; promoting the adoption of 

healthy behaviors with the objective of 

preventing and/or reducing chronic 

conditions associated with limb loss; 

increasing partnerships and 

collaborations with ACL programs that 

will benefit all people living with limb 

loss or limb differences; enhancing and 

expanding the evaluation activities 

currently under way; and enhancing 

website capacities for improved 

information dissemination. 

Program Name: National Limb Loss 

Resource Center. 

Recipient: The Amputee Coalition of 

America, Inc. 

Period of Performance: The 

supplement award will be issued for the 

third year of the three-year project 

period of April 1, 2016, through March 

29, 2019. 

Total Award Amount: $669,905 in FY 

2018. 

Award Type: Cooperative Agreement 

Supplement. 

Statutory Authority: This program is 

authorized under Section 317 of the 

Public Health Service Act (42 U.S.C. 

247(b–4)); Consolidated and Further 

Continuing Appropriations Act, 2015, 

Public Law 113–235 (Dec. 16, 2014). 

Basis for Award: The Amputee 

Coalition of America, Inc. is currently 

funded to carry out the objectives of this 

program, entitled The National Limb 

Loss Resource Center for the period of 

April 1, 2016, through March 29, 2019. 

Since the program transferred from CDC 

to ACL in late 2015, the grantee has 

accomplished a great deal. The 

supplement will enable the grantee to 

carry their work even further, serving 

more people living with limb loss and/ 

or limb differences and providing even 

more comprehensive training and 

technical assistance in the development 

of LTSS supportive services. The 

additional funding will not be used to 

begin new projects or activities. The 

NLLRC will enhance and expand 

currently funded activities such as 

conducting national outreach for the 

development and dissemination of 

patient education materials, programs, 

and services; providing technical 

support and assistance to community 

based limb loss support groups; and 

raising awareness about the limb loss 

and limb differences communities. 

Establishing an entirely new grant 

project at this time would be potentially 

disruptive to the current work already 

well under way. More importantly, the 

people living with limb loss and limb 

differences currently being served by 

this program could be negatively 

impacted by a service disruption, thus 

posing the risk of not being able to find 

the right resources that could negatively 

impact on health and wellbeing. If this 

supplement were not provided, the 

project would be less able to address the 

significant unmet needs of additional 

limb loss survivors. Similarly, the 

project would be unable to expand its 

current technical assistance and training 

efforts in NLLRC concepts and 

approaches, let alone reach beyond 

traditional providers of services to this 

population to train more ‘‘mainstream’’ 

providers of disability services. 

For More Information Contact: For 

further information or comments 

regarding this program supplement, 

contact Elizabeth Leef, U.S. Department 

of Health and Human Services, 

Administration for Community Living, 

Administration on Disabilities, 

Independent Living Administration: 

telephone (202) 475–2486; email 

Elizabeth.leef@acl.hhs.gov. 

Dated: June 6, 2018. 

Lance Robertson, 

Administrator and Assistant Secretary for 

Aging. 

[FR Doc. 2018–12978 Filed 6–14–18; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1788] 

Intravascular Catheters, Wires, and 

Delivery Systems With Lubricious 

Coatings—Labeling Considerations; 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices 27997 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Intravascular 

Catheters, Wires, and Delivery Systems 

with Lubricious Coatings—Labeling 

Considerations.’’ This draft guidance 

addresses labeling considerations for 

devices containing lubricious coatings 

that are used in the vasculature. The 

purpose of this draft guidance is to 

provide recommendations for 

information to be included in device 

labeling, as submitted in premarket 

applications (PMAs) or premarket 

notification submissions (510(k)s) for 

class III and class II devices, to enhance 

the consistency of information across 

these product areas as well as to 

promote the safe use of these devices in 

clinical settings. 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 August 14, 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–1788 for ‘‘Intravascular 

Catheters, Wires, and Delivery Systems 

with Lubricious Coatings—Labeling 

Considerations.’’ 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://

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 draft 

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 ‘‘Intravascular 

Catheters, Wires, and Delivery Systems 

with Lubricious Coatings—Labeling 

Considerations’’ 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 selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Leigh Anderson, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2656, Silver Spring, 

MD 20993–0002, 301–796–5613. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Hydrophilic- and/or hydrophobiccoated devices have been used for more 

than 20 years in minimally invasive 

diagnostic and therapeutic 

cerebrovascular, cardiovascular, and 

peripheral vascular procedures. 

Although these devices may offer 

patient benefits, evidence indicates that 

the coating may separate from 

intravascular devices in some 

circumstances. FDA has received and 

analyzed information concerning 

serious adverse events associated with 

hydrophilic and/or hydrophobic 

coatings separating (e.g., peeling, 

flaking, shedding, delaminating, or 

sloughing off) from intravascular 

medical devices. 

FDA has not concluded that any 

specific manufacturer or brand of these 

devices is associated with higher risks 

than others. The cause of coating 

separation is multifactorial, and can be 

associated with factors including device 

design, manufacturing, and use. Current 

FDA analysis suggests that use-related 

issues may be mitigated through proper 

device selection, preparation, and other 

labeling considerations that are 

addressed within this draft guidance. 

This draft guidance addresses labeling 

considerations for devices containing 

lubricious coatings used in the 

vasculature. The purpose of this draft 


sradovich on DSK3GMQ082PROD with NOTICES
27998 Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices 

guidance is to provide 

recommendations for information to be 

included in device labeling, as 

submitted in PMAs or 510(k)s for class 

III and class II devices, to enhance the 

consistency of coating information 

across these product areas as well as to 

promote the safe use of these devices in 

clinical settings. 

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 ‘‘Intravascular Catheters, Wires, and 

Delivery Systems with Lubricious 

Coatings—Labeling Considerations.’’ 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 

draft guidance document is also 

available at https://

www.regulations.gov. Persons unable to 

download an electronic copy of 

‘‘Intravascular Catheters, Wires, and 

Delivery Systems with Lubricious 

Coatings—Labeling Considerations’’ 

may send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 16016 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 21 CFR part 807, 

subpart E have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 814, subparts A through E have 

been approved under OMB control 

number 0910–0231; and the collections 

of information in 21 CFR part 801 have 

been approved under OMB control 

number 0910–0485. 

Dated: June 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12824 Filed 6–14–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1775] 

Coronary, Peripheral, and 

Neurovascular Guidewires— 

Performance Tests and Recommended 

Labeling; 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 ‘‘Coronary, Peripheral, 

and Neurovascular Guidewires— 

Performance Tests and Recommended 

Labeling.’’ This draft guidance provides 

recommendations for the information 

and testing that should be included in 

premarket submissions for guidewires 

intended for use in the coronary, 

peripheral, and neurovasculature. 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 August 14, 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–1775 for ‘‘Coronary, Peripheral, 

and Neurovascular Guidewires— 

Performance Tests and Recommended 

Labeling.’’ 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 


sradovich on DSK3GMQ082PROD with NOTICES