Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices 46737 

Federal Officer, NIOSH, CDC, 1600 

Clifton Road, Mailstop E–20, Atlanta, 

Georgia 30329, Telephone (513) 533– 

6800, Toll Free 1 (800) CDC–INFO, 

Email ocas@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Background: The Advisory Board was 

established under the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000 to advise the 

President on a variety of policy and 

technical functions required to 

implement and effectively manage the 

new compensation program. Key 

functions of the Advisory Board include 

providing advice on the development of 

probability of causation guidelines that 

have been promulgated by the 

Department of Health and Human 

Services (HHS) as a final rule; advice on 

methods of dose reconstruction, which 

have also been promulgated by HHS as 

a final rule; advice on the scientific 

validity and quality of dose estimation 

and reconstruction efforts being 

performed for purposes of the 

compensation program; and advice on 

petitions to add classes of workers to the 

Special Exposure Cohort (SEC). 

In December 2000, the President 

delegated responsibility for funding, 

staffing, and operating the Advisory 

Board to HHS, which subsequently 

delegated this authority to CDC. NIOSH 

implements this responsibility for CDC. 

The charter was issued on August 3, 

2001, renewed at appropriate intervals, 

rechartered on February 12, 2018, 

pursuant to Executive Order 13708, and 

will terminate on September 30, 2019. 

Purpose: The Advisory Board is 

charged with (a) providing advice to the 

Secretary, HHS, on the development of 

guidelines under Executive Order 

13179; (b) providing advice to the 

Secretary, HHS, on the scientific 

validity and quality of dose 

reconstruction efforts performed for this 

program; and (c) upon request by the 

Secretary, HHS, advise the Secretary on 

whether there is a class of employees at 

any Department of Energy facility who 

were exposed to radiation but for whom 

it is not feasible to estimate their 

radiation dose, and on whether there is 

reasonable likelihood that such 

radiation doses may have endangered 

the health of members of this class. SPR 

is responsible for overseeing, tracking, 

and participating in the reviews of all 

procedures used in the dose 

reconstruction process by the NIOSH 

Division of Compensation Analysis and 

Support (DCAS) and its dose 

reconstruction contractor (Oak Ridge 

Associated Universities—ORAU). 

Matters to be Considered: The agenda 

will include discussions on the 

following dose reconstruction 

procedures: (a) Procedures associated 

specifically with the following sites: 

Norton Company, Paducah, Blockson 

Chemical Company, DuPont Deepwater 

Works, Huntington Pilot Plan, Y–12, 

Aliquippa Forge, Hooker 

Electrochemical Plant; (b) procedures 

associated with Atomic Weapons 

Employers generally; and, (c) general 

procedures for dose reconstructions. 

Agenda items are subject to change as 

priorities dictate. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Sherri Berger, 

Chief Operating Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2018–20016 Filed 9–13–18; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP)—CE19–001, 

Injury Control Research Centers; 

Amended Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Disease, Disability, 

and Injury Prevention and Control 

Special Emphasis Panel (SEP)—CE19– 

001, Injury Control Research Centers; 

October 30 and November 2, 2018, 8:30 

a.m.–5:00 p.m., EDT, in the original 

FRN. 

The Georgian Terrace, 659 Peachtree 

St. NE, Atlanta, GA 30308 which was 

published in the Federal Register on 

August 23, 2018, Volume 83, Number 

164, pages 42655–42656. 

The meeting is being amended to 

change the location and time to the 

Sheraton Atlanta Hotel, 165 Courtland 

Street NE, Atlanta, GA 30303; October 

30–November 2, 2018, 8:00 a.m.–5:30 

p.m., EDT. The meeting is closed to the 

public. 

FOR FURTHER INFORMATION CONTACT: 

Mikel L. Walters, M.A., Ph.D., Scientific 

Review Official, NCIPC, CDC, 4770 

Buford Highway NE, Mailstop F–63, 

Atlanta, Georgia 30341, (404) 639–0913; 

mwalters@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Sherri Berger, 

Chief Operating Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2018–20024 Filed 9–13–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Intent To Award a Single-Source 

Supplement; Notice 

ACTION: Announcing the Intent to Award 

a Single-Source Supplement to provide 

the National Aging Network with 

timely, relevant, high quality 

opportunities to further enhance their 

knowledge and skills related to 

nutrition services. 

SUMMARY: The Administration for 

Community Living (ACL) announces the 

intent to award a single-source 

supplement to the current cooperative 

agreement held by Meals on Wheels 

America for the project Enhancing the 

Knowledge and Skills of the Aging 

Network. 

FOR FURTHER INFORMATION CONTACT: For 

further information or comments 

regarding this program supplement, 

contact Keri Lipperini, U.S. Department 

of Health and Human Services, 

Administration for Community Living, 

Administration on Aging, Office of 

Nutrition and Health Promotion 

Programs, 202–795–7422, email 

keri.lipperini@acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

purpose of this supplement is to: (1) 

Support the development and 

dissemination of resources for 

experienced and inexperienced Aging 

Network Nutrition Program providers; 

and (2) enhance peer-learning 

opportunities for State Units on Aging 

(SUAs), Area Agencies on Aging 

(AAAs), and Nutrition Program 

providers. 

The administrative supplement for FY 

2018 will be in the amount of $175,242, 

bringing the total award for FY 2018 to 

$400,001. 

The additional funding will not be 

used to begin new projects, but it will 

be used to enhance existing efforts. The 

grantee will continue to provide 

appropriate, quality nutrition-related 


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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. 


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