Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 65683 

section shall be made available for 

inspection and copying by FDA. 

Description of Respondents: 

Respondents include renderers, feed 

manufacturers, and others involved in 

feed and feed ingredient manufacturing 

and distribution. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

589.2000(e)(1)(iv); written procedures .. 320 1 320 14 4,480 

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

We base our estimates on our 

experience with similar requirements to 

maintain written procedures. We base 

our estimate of the number of 

recordkeepers on inspectional data. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: December 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27656 Filed 12–20–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–4465] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Administrative 

Detention and Banned Medical Devices 

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 information 

collection for administrative detention 

and banned medical devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 19, 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 19, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 19, 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– 

2018–N–4465 for ‘‘Administrative 

Detention and Banned Medical 

Devices.’’ 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 

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. 


amozie on DSK3GDR082PROD with NOTICES1
65684 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 

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. 

Administrative Detention and Banned 

Medical Devices—21 CFR 800.55(g)(1) 

and (g)(2), 800.55(k), 895.21(d), and 

895.229(a) 

OMB Control Number 0910–0114— 

Extension 

FDA has the statutory authority under 

section 304(g) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 334(g)) to detain during 

established inspections devices that are 

believed to be adulterated or 

misbranded. Section 800.55 (21 CFR 

800.55), on administrative detention, 

includes among other things certain 

reporting requirements (§ 800.55(g)(1) 

and (g)(2)) and recordkeeping 

requirements (§ 800.55(k)). Under 

§ 800.55(g), an appellant of a detention 

order must show documentation of 

ownership if devices are detained at a 

place other than that of the appellant. 

Under § 800.55(k), the owner or other 

responsible person must supply records 

about how the devices may have 

become adulterated or misbranded, in 

addition to records of distribution of the 

detained devices. These recordkeeping 

requirements for administrative 

detentions permit FDA to trace devices 

for which the detention period expired 

before a seizure is accomplished or 

injunctive relief is obtained. 

FDA also has the statutory authority 

under section 516 of the FD&C Act (21 

U.S.C. 360f) to ban devices that present 

substantial deception or an 

unreasonable and substantial risk of 

illness or injury. Section 895.21 (21 CFR 

895.21), on banned devices, contains 

certain reporting requirements. Section 

895.21(d) describes the procedures for 

banning a device when the 

Commissioner of Food and Drugs (the 

Commissioner) decides to initiate such 

a proceeding. Under 21 CFR 895.22, a 

manufacturer, distributor, or importer of 

a device may be required to submit to 

FDA all relevant and available data and 

information to enable the Commissioner 

to determine whether the device 

presents substantial deception, 

unreasonable and substantial risk of 

illness or injury, or unreasonable, direct, 

and substantial danger to the health of 

individuals. 

During the past several years, there 

has been an average of less than one 

new administrative detention action per 

year. Each administrative detention will 

have varying amounts of data and 

information that must be maintained. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Documentation of ownership—800.55(g) ............................ 1 1 1 25 25 

Banned devices reporting requirements—895.21(d)(8) and 

895.22(a) .......................................................................... 26 1 26 16 416 

Total .............................................................................. ........................ ........................ ........................ ........................ 441 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Records regarding device adulteration or misbranding and 

records of distribution of detained devices—800.55(k) ... 1 1 1 20 20 

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


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 65685 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: December 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27655 Filed 12–20–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3552] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Experimental 

Study of Cigarette Warnings 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 January 22, 

2019. 

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–NEW and 

title ‘‘Experimental Study of Cigarette 

Warnings.’’ 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. 

Experimental Study of Cigarette 

Warnings 

OMB Control Number 0910–NEW 

The Tobacco Control Act (Pub. L. 

111–31) amends the Federal Food, Drug, 

and Cosmetic Act to grant FDA 

authority to regulate the manufacture, 

marketing, and distribution of tobacco 

products to protect the public health 

and to reduce tobacco use by minors. 

Section 201 of the Tobacco Control Act 

amends section 4 of the Federal 

Cigarette Labeling and Advertising Act 

(FCLAA) (15 U.S.C. 1333) to require 

FDA to issue regulations that require 

color graphics depicting the negative 

health consequences of smoking to 

accompany the label statements 

specified in subsection 4(a)(1) of the 

FCLAA. Section 202(b) of the Tobacco 

Control Act further amends section 4 of 

the FCLAA by adding that the Secretary 

of Health and Human Services 

(Secretary), through notice and 

comment rulemaking, may adjust the 

text of any of the label requirements if 

the Secretary finds that such a change 

would promote greater public 

understanding of the risks associated 

with the use of tobacco products. 

In the Federal Register of June 22, 

2011 (76 FR 36628), FDA issued a final 

rule entitled ‘‘Required Warnings for 

Cigarette Packages and 

Advertisements,’’ which specified nine 

images to accompany new textual 

warning statements for cigarettes. 

Although the rule was scheduled to 

become effective 15 months after it 

issued, a panel of the U.S. Court of 

Appeals of the District of Columbia 

held, on August 24, 2012, that the rule 

in its current form violated the First 

Amendment. In a letter to Congress on 

March 15, 2013, the Attorney General 

reported FDA’s intention to undertake 

research to support a new rulemaking 

consistent with the Tobacco Control 

Act. Various phases of research have 

been underway since 2013. The next 

phase of the research includes the study 

proposed here, which is an effort by 

FDA to collect data concerning 

responses to health warnings placed on 

cigarette packages and advertisements 

for cigarettes. 

The health risks associated with the 

use of cigarettes are significant and farreaching. Cigarette smoking is the 

leading cause of preventable disease and 

death in the United States and is 

responsible for more than 480,000 

deaths per year. Smoking causes more 

deaths each year than human 

immunodeficiency virus, illegal drug 

use, alcohol use, motor vehicle injuries, 

and firearm-related incidents combined 

(Ref. 1). In addition to lung cancer, heart 

disease, and chronic obstructive 

pulmonary disease, smoking also causes 

numerous other serious health 

conditions including several types of 

cancer, premature birth, low birth 

weight, respiratory illnesses, clogged 

arteries, reduced blood flow, diabetes, 

and vision conditions such as agerelated macular degeneration and 

cataracts (Ref. 2). 

Approximately 37.8 million U.S. 

adults smoke cigarettes (Ref. 3) and 8.6 

million Americans have at least one 

serious illness caused by smoking 

cigarettes (Ref. 4). Results from the 2016 

National Survey on Drug Use and 

Health demonstrate that, each day in the 

United States, more than 2,300 youth 

under age 18 smoke their first cigarette, 

and nearly 400 youth become daily 

cigarette smokers (Ref. 5). If the current 

trajectory of smoking rates continues, 

5.6 million children alive today will die 

prematurely as a result of smoking (Ref. 

2). Providing the public with accurate 

information regarding the health 

consequences of cigarette use is critical 

in achieving FDA’s mission to protect 

the public health. 

This Experimental Study of Cigarette 

Warnings is a voluntary online 

experiment. The purpose of the study is 

to assess whether new cigarette health 

warnings increase public understanding 

of the negative health consequences of 

cigarette smoking. The study will collect 

data from various groups of consumers, 

including adolescent current cigarette 

smokers aged 13 to 17 years, adolescent 

non-smokers who are susceptible to 

initiation of cigarette smoking aged 13 

to 17 years, young adult current 

cigarette smokers and non-smokers aged 

18 to 24 years, and older adult current 

cigarette smokers and non-smokers aged 

25 years and older. The results will 

inform the Agency’s efforts to 

implement the mandatory color 

graphics to accompany health warning 

label statements as required by section 

4 of FCLAA. 

Study Overview: In this study, 

adolescent current cigarette smokers, 

adolescent non-smokers who are 

susceptible to initiation of cigarette 

smoking, young adult current cigarette 

smokers and non-smokers, and older 

adult current cigarette smokers and nonsmokers will be recruited from an 

existing internet panel of more than 1.2 

million people and screened for 

inclusion into the study. Participants 

who meet the inclusion criteria will be 

randomized into 1 of 17 conditions. In 

each condition, respondents will view 

one cigarette warning. In the 16 

treatment conditions, participants will 

view 1 cigarette health warning, 

containing a textual warning statement 


amozie on DSK3GDR082PROD with NOTICES1