Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices 67287 

Washington, DC 20201. Additional 

information is available at https://

www.acf.hhs.gov/otip/partnerships/thenational-advisory-committee. 

SUPPLEMENTARY INFORMATION: The 

formation and operation of the NAC are 

governed by the provisions of Public 

Law 92–463, as amended (5 U.S.C. App. 

2), which sets forth standards for the 

formation and use of federal advisory 

committees. 

Purpose of the NAC: The purpose of 

the NAC is to advise the Secretary and 

the Attorney General on practical and 

general policies concerning 

improvements to the nation’s response 

to the sex trafficking of children and 

youth in the United States. The NAC is 

established pursuant to Section 121 of 

the Preventing Sex Trafficking and 

Strengthening Families Act of 2014 

(Pub. L. 113–183). 

Tentative Agenda: The agenda can be 

found at https://www.acf.hhs.gov/otip/ 

partnerships/the-national-advisorycommittee. 

To submit written statements or RSVP 

to attend, email Ava.Donald@

acf.hhs.gov by January 2, 2019. Please 

include your name, organization, and 

phone number. More details on these 

options are below. 

Public Accessibility to the Meeting: 

Pursuant to 5 U.S.C. 552b and 41 CFR 

102–3.140 through 102–3.165, and 

subject to the availability of space, this 

meeting is open to the public. Seating is 

on a first to arrive basis. Security 

screening and a photo ID are required. 

The building is fully accessible to 

individuals with disabilities. Note: The 

January 9, 2019 meeting will only be 

held virtually. 

Written Comments or Statements: 

Pursuant to 41 CFR 102–3.105(j) and 

102–3.140 and section 10(a)(3) of the 

FACA, the public or interested 

organizations may submit written 

comments or statements to the NAC in 

response to the stated agenda of the 

meeting or in regard to the committee’s 

mission in general. Organizations with 

recommendations on best practices are 

encouraged to submit their comments or 

resources (hyperlinks preferred). 

Written comments or statements 

received after January 2, 2019 may not 

be provided to the Committee until its 

next meeting. 

Verbal Comments or Statements: 

Pursuant to 41 CFR 102–3.140d, the 

Committee is not obligated to allow a 

member of the public to speak or 

otherwise address the Committee during 

the meeting. Members of the public are 

invited to provide verbal statements 

during the Committee meeting only at 

the time and manner described in the 

agenda. The request to speak should 

include a brief statement of the subject 

matter to be addressed and should be 

relevant to the stated agenda of the 

meeting or the Committee’s mission in 

general. 

Minutes: The minutes of this meeting 

will be available for public review and 

copying within 90 days at: https://

www.acf.hhs.gov/otip/partnerships/thenational-advisory-committee. 

Dated: December 20, 2018. 

Lynn A. Johnson, 

Acting Assistant Secretary for Children and 

Families. 

[FR Doc. 2018–28264 Filed 12–27–18; 8:45 am] 

BILLING CODE 4184–40–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0536] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Device 

User Fee Cover Sheet, Form FDA 3601 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on Form FDA 3601, 

entitled ‘‘Medical Device User Fee 

Cover Sheet,’’ which must be submitted 

along with certain medical device 

product applications, supplements, and 

fee payment of those applications. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 26, 2019. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before February 26, 

2019. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 26, 2019. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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– 

2012–N–0536 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Medical 

Device User Fee Cover Sheet, Form FDA 

3601.’’ Received comments, those filed 

in a timely manner (see ADDRESSES), 

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 


amozie on DSK3GDR082PROD with NOTICES1
67288 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices 

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. 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Medical Device User Fee Cover Sheet, 

Form FDA 3601 

OMB Control Number 0910–0511— 

Extension 

The Federal Food, Drug, and Cosmetic 

Act, as amended by the Medical Device 

User Fee and Modernization Act of 2002 

(Pub. L. 107–250), and the Medical 

Device User Fee Amendments of 2007 

(title II of the Food and Drug 

Administration Amendments Act of 

2007), authorizes FDA to collect user 

fees for certain medical device 

applications. Under this authority, 

companies pay a fee for certain new 

medical device applications or 

supplements submitted to the Agency 

for review. Because the submission of 

user fees concurrently with applications 

and supplements is required, the review 

of an application cannot begin until the 

fee is submitted. Form FDA 3601, the 

‘‘Medical Device User Fee Cover Sheet,’’ 

is designed to provide the minimum 

necessary information to determine 

whether a fee is required for review of 

an application, to determine the amount 

of the fee required, and to account for 

and track user fees. The form provides 

a cross-reference between the fees 

submitted for an application with the 

actual submitted application by using a 

unique number tracking system. The 

information collected is used by FDA’s 

Center for Devices and Radiological 

Health and the Center for Biologics 

Evaluation and Research to initiate the 

administrative screening of new medical 

device applications and supplemental 

applications. 

The total number of annual responses 

is based on the average number of cover 

sheet submissions received by FDA in 

recent years. The number of received 

annual responses includes cover sheets 

for applications that were qualified for 

small businesses and fee waivers or 

reductions. The estimated hours per 

response are based on past FDA 

experience with the various cover sheet 

submissions, and range from 5 to 30 

minutes. The hours per response are 

based on the average of these estimates 

(18 minutes). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses Average burden per response Total hours 

3601 .................. 6,379 1 6,379 0.30 (18 minutes) ............................................................. 1,914 

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

Our estimated burden for the 

information collection reflects an 

overall increase of 350 hours and a 

corresponding increase of 1,165 

responses/records. We attribute this 

adjustment to an increase in the number 

of submissions we received over the last 

few years. 

Dated: December 20, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–28220 Filed 12–27–18; 8:45 am] 

BILLING CODE 4164–01–P 


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