39106 Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section FDA 

form No. 

Number of 

respondents 

Number 

of responses 

per respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

Supporting data for reclassification petition—21 CFR 860.123 ......................... ........................ 6 1 6 497 2,982 

Supplemental Data Sheet ........................ 3427 6 1 6 1.5 9 

General Device Classification Questionnaire ...................................................... 3429 6 1 6 1.5 9 

Total .................................................. ........................ ........................ ........................ ........................ ........................ 3,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on reclassification petitions 

received in the past 3 years, FDA 

anticipates that six petitions will be 

submitted each year. The time required 

to prepare and submit a reclassification 

petition, including the time needed to 

assemble supporting data, averages 500 

hours per petition. This average is based 

upon estimates by FDA administrative 

and technical staff who: (1) Are familiar 

with the requirements for submission of 

a reclassification petition, (2) have 

consulted and advised manufacturers on 

these requirements, and (3) have 

reviewed the documentation submitted. 

The burden estimate for this 

information collection has not changed 

since the past OMB approval. 

Dated: August 2, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16983 Filed 8–7–18; 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; 

Correction 

AGENCY: Office of the Assistant 

Secretary for Health, President’s Council 

on Sports, Fitness, and Nutrition, Office 

of the Secretary, Department of Health 

and Human Services. 

ACTION: Notice of meeting; correction. 

SUMMARY: The Department of Health and 

Human Services published a document 

in the Federal Register of July 27, 2018, 

concerning the upcoming annual 

meeting of the President’s Council on 

Sports, Fitness, and Nutrition (PCSFN). 

The document contained an incorrect 

location and time. 

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. 

Correction 

In the Federal Register of July 27, 

2018, in FR Vol. 83 No. 145, on page 

35662, in the second column, correct 

the DATES and ADDRESSES captions to 

read: 

DATES: The meeting will be held on 

September 21, 2018, from 9:00 a.m. to 

12:30 p.m. 

ADDRESSES: Hubert H. Humphrey 

Building, 200 Independence Avenue 

SW, Room 800, Washington, DC 20201. 

Dated: August 1, 2018. 

Holli M. Richmond, 

Executive Director, Office of the President’s 

Council on Sports, Fitness, and Nutrition, 

U.S. Department of Health and Human 

Services. 

[FR Doc. 2018–16970 Filed 8–7–18; 8:45 am] 

BILLING CODE 4150–35–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the President’s Council on 

Sports, Fitness, and Nutrition; 

Correction 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of the Assistant Secretary for 

Health, President’s Council on Sports, 

Fitness, and Nutrition. 

ACTION: Notice of meeting; correction. 

SUMMARY: The Department of Health and 

Human Services published a document 

in the Federal Register of July 27, 2018, 

concerning the upcoming annual 

meeting of the President’s Council on 

Sports, Fitness, and Nutrition (PCSFN). 

The document contained an incorrect 

location and time. 

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. 

Correction 

In the Federal Register of July 27, 

2018, in FR Vol. 83 No. 145, on page 

35662, in the second column, correct 

the DATES and ADDRESSES captions to 

read: 

DATES: The meeting will be held on 

September 21, 2018, from 9:00 a.m. to 

12:30 p.m. 

ADDRESSES: Hubert H. Humphrey 

Building, 200 Independence Avenue 

SW, Room 800, Washington, DC 20201. 

Dated: August 1, 2018. 

Holli M. Richmond, 

Executive Director, Office of the President’s 

Council on Sports, Fitness, and Nutrition, 

U.S. Department of Health and Human 

Services. 

[FR Doc. 2018–16969 Filed 8–7–18; 8:45 am] 

BILLING CODE 4150–35–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Nursing Research; 

Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory 

Council for Nursing Research. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 


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