46738 Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices 

resources, address new opportunities to 

embed nutrition services within the 

home and community-based service 

systems, and engage successfully in 

emerging models of integrated health 

care. 

Program Name: Enhancing the 

Knowledge and Skills of the Aging 

Network. 

Recipient: Meals on Wheels America. 

Period of Performance: The 

supplement award will be issued for the 

second year of a three year project 

period of Sept 1, 2017 to August 31, 

2020. 

Total Award Amount: $400,001 in FY 

2018. 

Award Type: Cooperative Agreement 

Supplement. 

Statutory Authority: The Older 

Americans Act (OAA) of 1965, as 

amended, Public Law 114–144. 

Basis for Award: Meals on Wheels 

America (MOWA) is currently funded to 

carry out the objectives of this project 

through its current project entitled, 

National Resource Center on Nutrition 

and Aging for the period of September 

1, 2017 through August 31, 2020. Since 

the project’s implementation, the 

grantee has made satisfactory progress 

toward its approved work plan. The 

supplement will enable the grantee to 

carry their work even further, enhancing 

the support they provide to the Aging 

Network Nutrition Program Providers. 

The additional funding will not be used 

to begin new projects or activities, but 

rather to enhance efforts specific to 

tribal populations and congregate meal 

settings. 

MOWA is uniquely positioned to 

complete the work called for under this 

project. They have an already 

established infrastructure and are a 

known and trusted organization in the 

Aging Network. Prior to this current 

award, MOWA competed and was 

awarded the National Nutrition Center 

for 6 years. They have an established 

presence within much of the Aging 

Network. Under this current award 

period, they are providing educational 

opportunities for the Aging Network 

Nutrition Program Providers, including 

webinars and live trainings. They have 

a comprehensive, interactive web-based 

repository (www.nutritionandaging.org) 

with tools and resources, including— 

but not limited to—issues briefs, policy 

and practice models, and toolkits. They 

have also presented to the Aging 

Network locally and on a national level. 

They have reached thousands of 

providers using their: (1) 

Comprehensive database of SUAs, 

AAAs, and other Nutrition Program 

Providers; and (2) Leadership Academy, 

which provides expert consultation 

around nutrition program delivery and 

the use of technology to enhance 

services. In addition, they have 

developed partnerships with 

organizations, universities, and other 

entities to provide education and 

support for the Aging Network. 

Establishing an entirely new grant 

project at this time would be potentially 

disruptive to the current work already 

well under way. More importantly, it 

could cause confusion among the Aging 

Network Nutrition Program Providers, 

which could have a negative effect on 

training and support opportunities. If 

this supplement were not provided, the 

project would be unable to address the 

significant unmet educational needs of 

the Aging Network Nutrition Program 

Providers. 

Dated: September 5, 2018. 

Mary Lazare, 

Principal Deputy Administrator. 

[FR Doc. 2018–19925 Filed 9–13–18; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0456] 

Appropriate Use of Voluntary 

Consensus Standards in Premarket 

Submissions for Medical Devices; 

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 a final 

guidance entitled ‘‘Appropriate Use of 

Voluntary Consensus Standards in 

Premarket Submissions for Medical 

Devices.’’ Voluntary consensus 

standards can be a valuable resource for 

industry and FDA staff because such 

standards can increase predictability, 

streamline premarket review, provide 

clearer regulatory expectations, and 

facilitate market entry for safe and 

effective medical products. FDA 

developed this document to provide 

guidance to industry and FDA reviewers 

about the appropriate use of voluntary 

consensus standards in the preparation 

and evaluation of premarket 

submissions for medical devices. This 

guidance applies to all articles that meet 

the definition of a ‘‘device’’ under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 14, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2014–D–0456 for ‘‘Appropriate Use of 

Voluntary Consensus Standards in 

Premarket Submissions for Medical 

Devices.’’ 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. 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices 46739 

• 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 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 guidance 

document entitled ‘‘Appropriate Use of 

Voluntary Consensus Standards in 

Premarket Submissions for Medical 

Devices’’ 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 or the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Scott Colburn, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5514, Silver Spring, 

MD 20993–0002, 301–796–6287; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In 1996, Congress passed the National 

Technology Transfer and Advancement 

Act (NTTAA) (Pub. L. 104–113). The 

NTTAA codified guidance previously 

issued by the Office of Management and 

Budget (OMB), which had established a 

policy to use voluntary consensus 

standards in lieu of government-unique 

standards except where voluntary 

consensus standards are inconsistent 

with law or otherwise impractical. 

Section 514(c) of the FD&C Act provides 

FDA the authority to recognize 

voluntary consensus standards and 

accept declarations of conformity to 

such standards (see 21 U.S.C. 360d(c)). 

Voluntary consensus standards can be 

a valuable resource for industry and 

FDA staff because such standards can 

increase predictability, streamline 

premarket review, provide clearer 

regulatory expectations, and facilitate 

market entry for safe and effective 

medical products. The Agency 

developed this document to provide 

guidance to industry and FDA staff 

about the appropriate use of voluntary 

consensus standards in the preparation 

and evaluation of premarket 

submissions for medical devices. This 

guidance applies to all articles that meet 

the definition of a ‘‘device’’ under 

section 201(h) of the FD&C Act (21 

U.S.C. 321(h)). 

FDA considered comments received 

on the draft guidance that appeared in 

the Federal Register of May 13, 2014 (79 

FR 27311). FDA revised the guidance as 

appropriate in response to the 

comments. This guidance supersedes: 

(1) ‘‘Guidance for Industry and FDA 

Staff; Recognition and Use of Consensus 

Standards,’’ issued on September 17, 

2007; (2) ‘‘Frequently Asked Questions 

on Recognition of Consensus 

Standards,’’ issued on September 17, 

2007; and (3) ‘‘Guidance for Industry 

and for FDA Staff: Use of Standards in 

Substantial Equivalence 

Determinations,’’ issued on March 12, 

2000. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Appropriate Use of 

Voluntary Consensus Standards in 

Premarket Submissions for Medical 

Devices.’’ 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 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. 

Guidance documents are also available 

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

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or https:// 

www.regulations.gov. Persons unable to 

download an electronic copy of 

‘‘Appropriate Use of Voluntary 

Consensus Standards in Premarket 

Submissions for Medical Devices’’ may 

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

electronic copy of the document. Please 

use the document number 1770 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information. 

These collections of information are 

subject to review by the OMB under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). The collections of 

information in the following FDA 

regulations, guidance, and form have 

been approved by OMB as listed in the 

following table: 


daltland on DSKBBV9HB2PROD with NOTICES
46740 Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices 

21 CFR part. guidance, or FDA form Topic 

OMB 

control 

No. 

807, subpart E and Form FDA 3654 .............................................................. Premarket Notification ............................................ 0910–0120 

814, subparts A through E ............................................................................. Premarket Approval ............................................... 0910–0231 

814, subpart H ................................................................................................ Humanitarian Device Exemption ............................ 0910–0332 

‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff‘‘.Q-Submissions ....................................................... 0910–0756 

820 .................................................................................................................. Current Good Manufacturing Practice; Quality 

System Regulation.

0910–0073 

312 .................................................................................................................. Investigational New Drug Regulation ..................... 0910–0014 

601 .................................................................................................................. Biologics License Application ................................. 0910–0338 

Dated: September 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19989 Filed 9–13–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2936] 

Recognition and Withdrawal of 

Voluntary Consensus Standards; 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, Agency, or we) is 

announcing the availability of the draft 

guidance entitled ‘‘Recognition and 

Withdrawal of Voluntary Consensus 

Standards.’’ This draft guidance 

identifies the principles FDA uses for 

recognizing a standard, and it explains 

the extent of recognition and other 

supplementary information. It provides 

information on how you may request 

recognition as well as circumstances 

under which FDA may withdraw 

recognition. This draft guidance also 

responds to a provision of the 21st 

Century Cures Act (Cures Act) by 

updating published guidance on these 

topics. 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 November 13, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit either electronic or written 

comments on the collection of 

information by November 13, 2018. 

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–2936 for ‘‘Recognition and 

Withdrawal of Voluntary Consensus 

Standards.’’ 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. 


daltland on DSKBBV9HB2PROD with NOTICES