Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices 39105 

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. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information that 

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 314 for 

submitting NDAs and abbreviated new 

drug applications, including 

supplemental applications and annual 

reports, have been approved under OMB 

control number 0910–0001. The 

collections of information in 21 CFR 

parts 211 and 212 (current good 

manufacturing practices) have been 

approved under OMB control numbers 

0910–0139 and 0910–0667. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, or https://www.fda.gov/

BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or https://

www.regulations.gov. 

Dated: August 3, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16984 Filed 8–7–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0776] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Reclassification 

Petitions for Medical Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by September 

7, 2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0138. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Reclassification Petitions for Medical 

Devices 

OMB Control Number 0910–0138— 

Extension 

Under sections 513(e) and (f), 514(b), 

515(b), and 520(l) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 360c(e) and (f), 360d(b), 360e(b), 

and 360j(l)) and part 860 (21 CFR part 

860), subpart C, FDA has the 

responsibility to collect data and 

information contained in 

reclassification petitions. The 

reclassification provisions of the FD&C 

Act allow any person to petition for 

reclassification of a device from any of 

the three classes, i.e., I, II, and III, to 

another class. The reclassification 

content regulation (§ 860.123) requires 

the submission of valid scientific 

evidence demonstrating that the 

proposed reclassification will provide a 

reasonable assurance of safety and 

effectiveness of the device type for its 

indications for use. 

The reclassification procedure 

regulation requires the submission of 

specific data when a manufacturer is 

petitioning for reclassification. This 

includes a ‘‘Supplemental Data Sheet,’’ 

Form FDA 3427, and a ‘‘General Device 

Classification Questionnaire,’’ Form 

FDA 3429. Both forms contain a series 

of questions concerning the safety and 

effectiveness of the device type. 

In the Federal Register of March 25, 

2014 (79 FR 16252), FDA issued a 

proposed rule that would eliminate the 

need for Forms FDA 3427 and 3429. 

However, because the proposed rule has 

not been finalized, we continue to 

include the forms in the burden 

estimate for this information collection. 

The reclassification provisions of the 

FD&C Act serve primarily as a vehicle 

for manufacturers to seek 

reclassification from a higher to a lower 

class, thereby reducing the regulatory 

requirements applicable to a particular 

device type, or to seek reclassification 

from a lower to a higher class, thereby 

increasing the regulatory requirements 

applicable to that device type. If 

approved, petitions requesting 

classification from class III to class II or 

class I provide an alternative route to 

market in lieu of premarket approval for 

class III devices. If approved, petitions 

requesting reclassification from class I 

or II, to a different class, may increase 

requirements. 

In the Federal Register of March 07, 

2018 (83 FR 9743), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. FDA received one 

comment. 

The comment supports continued use 

of Forms FDA 3427 and FDA 3429. 

Specifically, the commenter is 

addressing the issue of discontinuing 

the forms as previously referenced, 

wherein FDA issued a proposed rule (79 

FR 16252) to eliminate the need for the 

forms. Because FDA is not 

discontinuing use of the forms at this 

time, and this comment relates to the 

proposed rule (79 FR 16252) and not to 

the information collection itself, we 

make no changes to this information 

collection based on the comment. 

The Center for Devices and 

Radiological Health (CDRH) has 

continually maintained contact with 

industry. Informal communications 

concerning the importance and effect of 

reclassification are provided primarily 

through trade organizations, and via 

CDRH’s website (https://www.fda.gov/ 

MedicalDevices/default.htm). 

FDA estimates the burden of this 

collection of information as follows: 


sradovich on DSK3GMQ082PROD with NOTICES
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 


sradovich on DSK3GMQ082PROD with NOTICES