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single hard copy of the draft guidance 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developed this draft guidance for 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This draft guidance is being issued 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The draft guidance, when finalized, will 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, 


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35660 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 

1The term ‘‘food’’ for purposes of this document 

has the same meaning as such term in section 201(f) 

of the FD&C Act (21 U.S.C. 321(f)). 

301–796–5957, email: Jason.Lewis@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 107 of FSMA (Pub. L. 111– 

353) added section 743 to the FD&C Act 

(21 U.S.C. 379j–31) to provide FDA with 

the authority to assess and collect fees 

from, in part: (1) The responsible party 

for each domestic facility and the U.S. 

agent for each foreign facility subject to 

a reinspection, to cover reinspectionrelated costs; (2) the responsible party 

for a domestic facility and an importer 

who does not comply with a recall 

order, to cover food 1 recall activities 

associated with such order; and (3) each 

importer subject to a reinspection to 

cover reinspection-related costs (section 

743(a)(1)(A), (B), and (D) of the FD&C 

Act). Section 743 of the FD&C Act 

directs FDA to establish fees for each of 

these activities based on an estimate of 

100 percent of the costs of each activity 

for each year (section 743(b)(2)(A)(i), 

(ii), and (iv)), and these fees must be 

made available solely to pay for the 

costs of each activity for which the fee 

was incurred (section 743(b)(3)). These 

fees are effective on October 1, 2018, 

and will remain in effect through 

September 30, 2019. Section 

743(b)(2)(B)(iii) of the FD&C Act directs 

FDA to develop a proposed set of 

guidelines in consideration of the 

burden of fee amounts on small 

businesses. As a first step in developing 

these guidelines, FDA invited public 

comment on the potential impact of the 

fees authorized by section 743 of the 

FD&C Act on small businesses (76 FR 

45818, August 1, 2011). The comment 

period for this request ended November 

30, 2011. As stated in FDA’s September 

2011 ‘‘Guidance for Industry: 

Implementation of the Fee Provisions of 

Section 107 of the FDA Food Safety 

Modernization Act,’’ (http://

www.fda.gov/Food/ 

GuidanceRegulation/

GuidanceDocuments

RegulatoryInformation/FoodDefense/ 

ucm274176.htm), because FDA 

recognizes that for small businesses the 

full cost recovery of FDA reinspection 

or recall oversight could impose severe 

economic hardship, FDA intends to 

consider reducing certain fees for those 

firms. FDA does not intend to issue 

invoices for reinspection or recall order 

fees until FDA publishes a guidance 

document outlining the process through 

which firms may request a reduction in 

fees. 

In addition, as stated in the 

September 2011 Guidance, FDA is in 

the process of considering various 

issues associated with the assessment 

and collection of importer reinspection 

fees. The fee rates set forth in this notice 

will be used to determine any importer 

reinspection fees assessed in FY 2019. 

II. Estimating the Average Cost of a 

Supported Direct FDA Work Hour for 

FY 2019 

FDA is required to estimate 100 

percent of its costs for each activity to 

establish fee rates for FY 2019. In each 

year, the costs of salary (or personnel 

compensation) and benefits for FDA 

employees account for between 50 and 

60 percent of the funds available to, and 

used by, FDA. Almost all of the 

remaining funds (operating funds) 

available to FDA are used to support 

FDA employees for paying rent, travel, 

utility, information technology (IT), and 

other operating costs. 

A. Estimating the Full Cost per Direct 

Work Hour in FY 2019 

Full-time equivalent (FTE) reflects the 

total number of regular straight-time 

hours—not including overtime or 

holiday hours—worked by employees, 

divided by the number of compensable 

hours applicable to each fiscal year. 

Annual leave, sick leave, compensatory 

time off, and other approved leave 

categories are considered ‘‘hours 

worked’’ for purposes of defining FTE 

employment. 

In general, the starting point for 

estimating the full cost per direct work 

hour is to estimate the cost of an FTE 

or paid staff year. Calculating an 

Agency-wide total cost per FTE requires 

three primary cost elements: Payroll, 

non-payroll, and rent. 

We have used an average of past year 

cost elements to predict the FY 2019 

cost. The FY 2019 FDA-wide average 

cost for payroll (salaries and benefits) is 

$157,731; non-payroll—including 

equipment, supplies, IT, general and 

administrative overhead—is $91,008; 

and rent, including cost allocation 

analysis and adjustments for other rent 

and rent-related costs, is $24,400 per 

paid staff year, excluding travel costs. 

Summing the average cost of an FTE 

for payroll, non-payroll, and rent, brings 

the FY 2019 average fully supported 

cost to $273,139 per FTE, excluding 

travel costs. FDA will use this base unit 

fee in determining the hourly fee rate for 

reinspection and recall order fees for FY 

2019 prior to including domestic or 

foreign travel costs as applicable for the 

activity. 

To calculate an hourly rate, FDA must 

divide the FY 2019 average fully 

supported cost of $273,139 per FTE by 

the average number of supported direct 

FDA work hours in FY 2017—the last 

FY for which data are available. See 

table 1. 

TABLE 1—SUPPORTED DIRECT FDA 

WORK HOURS IN A PAID STAFF

YEAR IN FY 2017 

Total number of hours in a paid staff 

year ...................................................... 2,080 

Less: 

10 paid holidays ...................................... ¥80 

20 days of annual leave .......................... ¥160 

10 days of sick leave .............................. ¥80 

12.5 days of training ............................... ¥100 

26.5 days of general administration ........ ¥184 

26.5 days of travel .................................. ¥212 

2 hours of meetings per week ................ ¥104 

Net Supported Direct FDA Work Hours 

Available for Assignments ................... 1,160 

Dividing the average fully supported 

FTE cost in FY 2019 ($273,139) by the 

total number of supported direct work 

hours available for assignment in FY 

2017 (1,160) results in an average fully 

supported cost of $235 (rounded to the 

nearest dollar), excluding inspection 

travel costs, per supported direct work 

hour in FY 2019. 

B. Adjusting FY 2017 Travel Costs for 

Inflation To Estimate FY 2019 Travel 

Costs 

To adjust the hourly rate for FY 2019, 

FDA must estimate the cost of inflation 

in each year for FY 2018 and FY 2019. 

FDA uses the method prescribed for 

estimating inflationary costs under the 

Prescription Drug User Fee Act 

(PDUFA) provisions of the FD&C Act 

(section 736(c)(1) (21 U.S.C. 379h(c)(1)), 

the statutory method for inflation 

adjustment in the FD&C Act that FDA 

has used consistently. FDA previously 

determined the FY 2018 inflation rate to 

be 1.6868 percent; this rate was 

published in the FY 2018 PDUFA user 

fee rates notice in the Federal Register 

(September 14, 2017, 82 FR 43244). 

Utilizing the method set forth in section 

736(c)(1) of the FD&C Act, FDA has 

calculated an inflation rate of 1.6868 

percent for 2018 and 1.7708 percent for 

2019, and FDA intends to use these 

inflation rates to make inflation 

adjustments for FY 2019 for several of 

its user fee programs; the derivation of 

this rate will be published in the 

Federal Register in the FY 2019 notice 

for the PDUFA user fee rates. 

The average fully supported cost per 

supported direct FDA work hour, 

excluding travel costs of $235 already 

takes into account inflation as the 

calculation above is based on FY 2019 


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predicted costs. FDA will use this base 

unit fee in determining the hourly fee 

rate for reinspection and recall order 

fees for FY 2019 prior to including 

domestic or foreign travel costs as 

applicable for the activity. In FY 2017, 

FDA’s Office of Regulatory Affairs 

(ORA) spent a total of $5,846,091 for 

domestic regulatory inspection travel 

costs and General Services 

Administration Vehicle costs related to 

FDA’s Center for Food Safety and 

Applied Nutrition (CFSAN) and Center 

for Veterinary Medicine (CVM) field 

activities programs. The total ORA 

domestic travel costs spent is then 

divided by the 10,289 CFSAN and CVM 

domestic inspections, which averages a 

total of $568 per inspection. These 

inspections average 34.05 hours per 

inspection. Dividing $568 per 

inspection by 34.05 hours per 

inspection results in a total and an 

additional cost of $17 (rounded to the 

nearest dollar) per hour spent for 

domestic inspection travel costs in FY 

2017. To adjust for the $17 per hour 

additional domestic cost inflation 

increases for FY 2018 and FY 2019, FDA 

must multiply the FY 2018 PDUFA 

inflation rate adjustor (1.016868) times 

the FY 2019 PDUFA inflation rate 

adjustor (1.017708) times the $17 

additional domestic cost, which results 

in an estimated cost of $18 (rounded to 

the nearest dollar) per paid hour in 

addition to $235 for a total of $253 per 

paid hour ($235 plus $18) for each 

direct hour of work requiring domestic 

inspection travel. FDA will use these 

rates in charging fees in FY 2019 when 

domestic travel is required. 

In FY 2017, ORA spent a total of 

$2,566,050 on 480 foreign inspection 

trips related to FDA’s CFSAN and CVM 

field activities programs, which 

averaged a total of $5,346 per foreign 

inspection trip. These trips averaged 3 

weeks (or 120 paid hours) per trip. 

Dividing $5,346 per trip by 120 hours 

per trip results in a total and an 

additional cost of $45 (rounded to the 

nearest dollar) per paid hour spent for 

foreign inspection travel costs in FY 

2017. To adjust $45 for inflationary 

increases in FY 2018 and FY 2019, FDA 

must multiply it by the same inflation 

factors mentioned previously in this 

document (1.016868 and 1.107708), 

which results in an estimated cost of 

$47 (rounded to the nearest dollar) per 

paid hour in addition to $235 for a total 

of $282 per paid hour ($235 plus $47) 

for each direct hour of work requiring 

foreign inspection travel. FDA will use 

these rates in charging fees in FY 2019 

when foreign travel is required. 

TABLE 2—FSMA FEE SCHEDULE FOR

FY 2019 

Fee category Fee rates 

for FY 2019 

Hourly rate if domestic travel 

is required ......................... $253 

Hourly rate if foreign travel is 

required ............................. 282 

III. Fees for Reinspections of Domestic 

or Foreign Facilities Under Section 

743(a)(1)(A) 

A. What will cause this fee to be 

assessed? 

The fee will be assessed for a 

reinspection conducted under section 

704 of the FD&C Act (21 U.S.C. 374) to 

determine whether corrective actions 

have been implemented and are 

effective and compliance has been 

achieved to the Secretary of Health and 

Human Services’ (the Secretary) (and, 

by delegation, FDA’s) satisfaction at a 

facility that manufactures, processes, 

packs, or holds food for consumption 

necessitated as a result of a previous 

inspection (also conducted under 

section 704) of this facility, which had 

a final classification of Official Action 

Indicated (OAI) conducted by or on 

behalf of FDA, when FDA determined 

the non-compliance was materially 

related to food safety requirements of 

the FD&C Act. FDA considers such noncompliance to include non-compliance 

with a statutory or regulatory 

requirement under section 402 of the 

FD&C Act (21 U.S.C. 342) and section 

403(w) of the FD&C Act (21 U.S.C. 

343(w)). However, FDA does not 

consider non-compliance that is 

materially related to a food safety 

requirement to include circumstances 

where the non-compliance is of a 

technical nature and not food safety 

related (e.g., failure to comply with a 

food standard or incorrect font size on 

a food label). Determining when noncompliance, other than under sections 

402 and 403(w) of the FD&C Act, is 

materially related to a food safety 

requirement of the FD&C Act may 

depend on the facts of a particular 

situation. FDA intends to issue guidance 

to provide additional information about 

the circumstances under which FDA 

would consider non-compliance to be 

materially related to a food safety 

requirement of the FD&C Act. 

Under section 743(a)(1)(A) of the 

FD&C Act, FDA is directed to assess and 

collect fees from ‘‘the responsible party 

for each domestic facility (as defined in 

section 415(b) (21 U.S.C. 350d(b))) and 

the United States agent for each foreign 

facility subject to a reinspection’’ to 

cover reinspection-related costs. 

Section 743(a)(2)(A)(i) of the FD&C 

Act defines the term ‘‘reinspection’’ 

with respect to domestic facilities as ‘‘1 

or more inspections conducted under 

section 704 subsequent to an inspection 

conducted under such provision which 

identified non-compliance materially 

related to a food safety requirement of 

th[e] Act, specifically to determine 

whether compliance has been achieved 

to the Secretary’s satisfaction.’’ 

The FD&C Act does not contain a 

definition of ‘‘reinspection’’ specific to 

foreign facilities. In order to give 

meaning to the language in section 

743(a)(1)(A) of the FD&C Act to collect 

fees from the U.S. agent of a foreign 

facility subject to a reinspection, the 

Agency is using the following definition 

of ‘‘reinspection’’ for purposes of 

assessing and collecting fees under 

section 743(a)(1)(A), with respect to a 

foreign facility, ‘‘1 or more inspections 

conducted by officers or employees duly 

designated by the Secretary subsequent 

to such an inspection which identified 

non-compliance materially related to a 

food safety requirement of the FD&C 

Act, specifically to determine whether 

compliance has been achieved to the 

Secretary’s (and, by delegation, FDA’s) 

satisfaction.’’ 

This definition allows FDA to fulfill 

the mandate to assess and collect fees 

from the U.S. agent of a foreign facility 

in the event that an inspection reveals 

non-compliance materially related to a 

food safety requirement of the FD&C 

Act, causing one or more subsequent 

inspections to determine whether 

compliance has been achieved to the 

Secretary’s (and, by delegation, FDA’s) 

satisfaction. By requiring the initial 

inspection to be conducted by officers 

or employees duly designated by the 

Secretary, the definition ensures that a 

foreign facility would be subject to fees 

only in the event that FDA, or an entity 

designated to act on its behalf, has made 

the requisite identification at an initial 

inspection of non-compliance materially 

related to a food safety requirement of 

the FD&C Act. The definition of 

‘‘reinspection-related costs’’ in section 

743(a)(2)(B) of the FD&C Act relates to 

both a domestic facility reinspection 

and a foreign facility reinspection, as 

described in section 743(a)(1)(A). 

B. Who will be responsible for paying 

this fee? 

The FD&C Act states that this fee is to 

be paid by the responsible party for each 

domestic facility (as defined in section 

415(b) of the FD&C Act) and by the U.S. 

agent for each foreign facility (section 

743(a)(1)(A) of the FD&C Act). This is 


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35662 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 

the party to whom FDA will send the 

invoice for any fees that are assessed 

under this section. 

C. How much will this fee be? 

The fee is based on the number of 

direct hours spent on such 

reinspections, including time spent 

conducting the physical surveillance 

and/or compliance reinspection at the 

facility, or whatever components of 

such an inspection are deemed 

necessary, making preparations and 

arrangements for the reinspection, 

traveling to and from the facility, 

preparing any reports, analyzing any 

samples or examining any labels if 

required, and performing other activities 

as part of the OAI reinspection until the 

facility is again determined to be in 

compliance. The direct hours spent on 

each such reinspection will be billed at 

the appropriate hourly rate shown in 

table 2 of this document. 

IV. Fees for Non-Compliance With a 

Recall Order Under Section 743(a)(1)(B) 

A. What will cause this fee to be 

assessed? 

The fee will be assessed for not 

complying with a recall order under 

section 423(d) (21 U.S.C. 350l(d)) or 

section 412(f) of the FD&C Act (21 

U.S.C. 350a(f)) to cover food recall 

activities associated with such order 

performed by the Secretary (and by 

delegation, FDA) (section 743(a)(1)(B) of 

the FD&C Act). Non-compliance may 

include the following: (1) Not initiating 

a recall as ordered by FDA; (2) not 

conducting the recall in the manner 

specified by FDA in the recall order; or 

(3) not providing FDA with requested 

information regarding the recall, as 

ordered by FDA. 

B. Who will be responsible for paying 

this fee? 

Section 743(a)(1)(B) of the FD&C Act 

states that the fee is to be paid by the 

responsible party for a domestic facility 

(as defined in section 415(b) of the 

FD&C Act) and an importer who does 

not comply with a recall order under 

section 423 or under section 412(f) of 

the FD&C Act. In other words, the party 

paying the fee would be the party that 

received the recall order. 

C. How much will this fee be? 

The fee is based on the number of 

direct hours spent on taking action in 

response to the firm’s failure to comply 

with a recall order. Types of activities 

could include conducting recall audit 

checks, reviewing periodic status 

reports, analyzing the status reports and 

the results of the audit checks, 

conducting inspections, traveling to and 

from locations, and monitoring product 

disposition. The direct hours spent on 

each such recall will be billed at the 

appropriate hourly rate shown in table 

2 of this document. 

V. How must the fees be paid? 

An invoice will be sent to the 

responsible party for paying the fee after 

FDA completes the work on which the 

invoice is based. Payment must be made 

within 90 days of the invoice date in 

U.S. currency by check, bank draft, or 

U.S. postal money order payable to the 

order of the Food and Drug 

Administration. Detailed payment 

information will be included with the 

invoice when it is issued. 

VI. What are the consequences of not 

paying these fees? 

Under section 743(e)(2) of the FD&C 

Act, any fee that is not paid within 30 

days after it is due shall be treated as a 

claim of the U.S. Government subject to 

provisions of subchapter II of chapter 37 

of title 31, United States Code. 

Dated: July 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16069 Filed 7–26–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the President’s Council on 

Sports, Fitness, and Nutrition 

AGENCY: President’s Council on Sports, 

Fitness, and Nutrition, Office of the 

Assistant Secretary for Health, Office of 

the Secretary, Department of Health and 

Human Services. 

ACTION: Notice of meeting. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the U.S. 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that the President’s Council on Sports, 

Fitness, and Nutrition (PCSFN) will 

hold its annual meeting. The meeting 

will be open to the public. 

DATES: The meeting will be held on 

September 21, 2018, from 9:30 a.m. to 

12:30 p.m. 

ADDRESSES: Newseum, Knight 

Conference Center 7th Floor, 555 

Pennsylvania Ave. NW, Washington, DC 

20001. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Holli M. Richmond, Executive Director, 

Office of the President’s Council on 

Sports, Fitness, and Nutrition, Tower 

Building, 1101 Wootton Parkway, Suite 

560, Rockville, MD 20852, (240) 276– 

9567. Information about PCSFN, 

including details about the upcoming 

meeting, can be obtained at 

www.fitness.gov. 

SUPPLEMENTARY INFORMATION: The 

primary functions of the PCSFN include 

(1) advising the President, through the 

Secretary, concerning progress made in 

carrying out the provisions of Executive 

Order 13265, as amended by Executive 

Order 13824, and recommending to the 

President, through the Secretary, actions 

to accelerate such progress; (2) 

recommending to the Secretary a 

national strategy to expand children’s 

participation in youth sports, encourage 

regular physical activity, including 

active play and promote good nutrition 

for all Americans. Recommendations 

may address, but are not necessarily 

limited to, increasing awareness of the 

benefits of participation in sports and 

regular physical activity, as well as the 

importance of good nutrition; promoting 

private and public sector strategies to 

increase participation in sports, 

encourage regular physical activity, and 

improve nutrition; developing metrics 

that gauge youth sports participation 

and physical activity to inform efforts 

that will improve participation in sports 

and regular physical activity among 

young Americans; and establishing a 

national and local strategy to recruit 

volunteers who will encourage and 

support youth participation in sports 

and regular physical activity, through 

coaching, mentoring, teaching, or 

administering athletic and nutritional 

programs. The Council’s performance of 

these functions shall take into account 

the Department of Health and Human 

Services’ Physical Activity Guidelines 

for Americans, including consideration 

for youth with disabilities. 

The Council shall meet, at a 

minimum, one time per fiscal year. The 

meeting will be held to (1) assess 

ongoing Council activities; and, (2) 

discuss and plan future projects and 

programs. The agenda for the planned 

meeting is being developed and will be 

posted at www.fitness.gov when it has 

been finalized. 

The meeting that is scheduled to be 

held on September 21, 2018, is open to 

the public and the media. Every effort 

will be made to provide reasonable 

accommodations for persons with 

disabilities and/or special needs who 

wish to attend the meeting. Persons 

with disabilities and/or special needs 

should call (240) 276–9567 no later than 

close of business Monday, September 

10, 2018, to request accommodations. 

Members of the public who wish to 

attend the meeting are asked to preregister by sending an email to 


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