42664 Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 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 

parts 312 and 314 have been approved 

under OMB control numbers 0910–0014 

and 0910–0001, respectively. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/default.htm, https://

www.fda.gov/MedicalDevices/Device

RegulationandGuidance/ 

GuidanceDocuments/default.htm, or 

https://www.regulations.gov. 

Dated: August 20, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18214 Filed 8–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0377] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Tobacco Health 

Document Submission 

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 Tobacco Health 

Document Submissions. 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 22, 2018. 

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 October 22, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 22, 2018. 

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– 

2013–N–0377 for ‘‘Tobacco Health 

Document Submission.’’ 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. 

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 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices 42665 

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. 

Tobacco Health Document Submission 

OMB Control Number 0910–0654— 

Extension 

On June 22, 2009, the President 

signed the Family Smoking Prevention 

and Tobacco Control Act (Tobacco 

Control Act) (Pub. L. 111–31) into law. 

The Tobacco Control Act amended the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) by adding, among other 

things, a new chapter granting FDA 

important authority to regulate the 

manufacture, marketing, and 

distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. 

Additionally, section 101 of the Tobacco 

Control Act amended the FD&C Act by 

adding, among other things, new section 

904(a)(4) (21 U.S.C. 387d(a)(4)). 

Section 904(a)(4) of the FD&C Act 

requires each tobacco product 

manufacturer or importer, or agent 

thereof, to submit all documents 

developed after June 22, 2009, ‘‘that 

relate to health, toxicological, 

behavioral, or physiologic effects of 

current or future tobacco products, their 

constituents (including smoke 

constituents), ingredients, components, 

and additives’’ (herein referred to as 

‘‘tobacco health documents’’). 

FDA announced the availability of a 

guidance on this collection in the 

Federal Register of April 4, 2010 (75 FR 

20606) (revised December 5, 2016 (81 

FR 87565) and August 10, 2017 (82 FR 

37459) (extending compliance dates)), 

and requested health documents that 

were created during the period of June 

23, 2009, through December 31, 2009 

based on the statutory requirements. 

The guidance stated that information 

required under section 904(a)(4) of the 

FD&C Act must be submitted to FDA 

beginning December 22, 2009. However, 

FDA also explained that it did not 

intend to enforce the December 22, 

2009, deadline provided that the 

documents were submitted by April 30, 

2010, for all health documents 

developed between June 23, 2009 and 

December 31, 2009. Further, FDA stated 

it would publish a revised guidance 

specifying the timing of subsequent 

reporting. 

FDA has been collecting the 

information submitted pursuant to 

section 904(a)(4) of the FD&C Act 

through a facilitative electronic form 

and through a paper form (Form FDA 

3743) for those individuals who choose 

not to use the electronic method. On 

both forms, FDA is requesting the 

following information from firms that 

have not already reported or still have 

documents to report: 

• Submitter identification 

• Submitter type, company name, 

address, country, company 

headquarters Dun and Bradstreet 

D–U–N–S number, and FDA assigned 

Facility Establishment Identifier (FEI) 

number 

• Submitter point of contact 

• Contact name, title, position title, 

email, telephone, and fax 

• Submission format and contents (as 

applicable) 

• Electronic documents: Media type, 

media quantity, size of submission, 

quantity of documents, file type, and 

file software 

• Paper documents: Quantity of 

documents, quantity of volumes, and 

quantity of boxes 

• Whether or not a submission is being 

provided 

• Confirmation statement 

• Identification and signature of 

submitter including name, company 

name, address, position title, email, 

telephone, and fax 

• Document categorization (as 

applicable): Relationship of the 

document or set of documents to the 

following: 

Æ Health, behavioral, toxicological, or 

physiological effects 

Æ Uniquely identified current or future 

tobacco product(s) 

Æ Category of current or future tobacco 

product(s) 

Æ Specific ingredient(s), constituent(s), 

component(s), or additive(s) 

Æ Class of ingredient(s), constituent(s), 

component(s), or additive(s) 

• Document readability and 

accessibility: Keywords; glossary or 

explanation of any abbreviations, jargon, 

or internal (e.g., code) names; special 

instructions for loading or compiling 

submission. 

• Document metadata: Date document 

was created, document author(s), 

document recipient(s), document 

custodian, document title or 

identification number, beginning and 

ending Bates numbers, Bates number 

ranges for documents attached to a 

submitted email, document type, and 

whether the document is present in the 

University of California San Francisco’s 

Truth Tobacco Documents database. 

In addition to the electronic and 

paper forms, FDA issued guidance 

documents intended to assist persons 

making tobacco health document 

submissions (draft guidance: December 

28, 2009 (74 FR 68629); final guidance: 

April 20, 2010 (75 FR 20606); revised 

December 5, 2016 (81 FR 87565) and 

August 10, 2017 (82 FR 37459) 

(extending compliance dates)). For 

further assistance, FDA is providing a 

technical guide, embedded hints, and a 

web tutorial on the electronic portal. 

FDA issued a final rule to deem 

products meeting the statutory 

definition of ‘‘tobacco product’’ to be 

subject to the FD&C Act on May 10, 

2016 (81 FR 28973), which became 

effective on August 8, 2016. The FD&C 

Act provides FDA authority to regulate 

cigarettes, cigarette tobacco, roll-yourown tobacco (RYO), smokeless tobacco, 

and any other tobacco products that the 

Agency by regulation deems to be 

subject to the law. This final rule 

extends the Agency’s ‘‘tobacco product’’ 

authorities to all other categories of 

products that meet the statutory 

definition of ‘‘tobacco product’’ in the 

FD&C Act, except accessories of such 

deemed tobacco products. 

For tobacco products subject to the 

deeming rule, FDA understands 

‘‘current or future tobacco products’’ to 

refer to products commercially 

distributed on or after August 8, 2016, 

or products in any stage of research or 

development at any time after August 8, 

2016, including experimental products 

and developmental products intended 

for introduction into the market for 

consumer use. For cigarettes, cigarette 

tobacco, RYO, and smokeless tobacco, 

FDA understands ‘‘current or future 

tobacco products’’ to refer to products 

commercially distributed on or after 


daltland on DSKBBV9HB2PROD with NOTICES
42666 Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices 

June 23, 2009, or products in any stage 

of research or development at any time 

after June 23, 2009, including 

experimental products and 

developmental products intended for 

introduction into the market for 

consumer use. 

All manufacturers and importers of 

tobacco products are now subject to the 

FD&C Act and are required to comply 

with section 904(a)(4), which requires 

immediate and ongoing submission of 

health documents developed after June 

22, 2009 (the date of enactment of the 

Tobacco Control Act). However, FDA 

generally does not intend to enforce the 

requirement at this time with respect to 

all such health documents relating to 

the deemed tobacco products, so long as 

a specified set of documents, those 

developed between June 23, 2009, and 

December 31, 2009, were submitted by 

February 8, 2017, or in the case of smallscale deemed tobacco product 

manufacturers (small-scale 

manufacturers), by November 8, 2017 

(81 FR 28974 at 29008–09). 

Additionally, FDA extended the 

compliance deadlines by an additional 

6 months for small-scale manufacturers 

in the areas impacted by recent natural 

disasters to May 8, 2018. Thereafter, 

FDA’s compliance plan requests 

deemed manufacturers provide tobacco 

health document submissions from the 

specified period, at least 90 days prior 

to the delivery for introduction into 

interstate commerce of tobacco products 

to which the health documents relate. 

Manufacturers or importers of cigarettes, 

cigarette tobacco, RYO, or smokeless 

tobacco products must provide all 

health documents developed between 

June 23, 2009, and December 31, 2009, 

at least 90 days prior to the delivery for 

introduction of tobacco products into 

interstate commerce. FDA estimates the 

burden of this collection of information 

as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Tobacco Health Document Submissions and Form FDA 

3743 .................................................................................. 10 3.2 32 50 1,600 

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

The number of documents received 

each year since the original collection 

period has fallen to less than 5 percent 

of what was received in the original 

collection period. FDA expects this is 

because documents created within the 

specified period should have already 

been submitted. The Agency bases this 

estimate on the total number of tobacco 

firms it is aware of and its experience 

with document production and the 

number of additional documents that 

have been reported each year since the 

original estimate of the reporting 

burden. 

FDA estimates that a tobacco health 

document submission for cigars, pipe 

and waterpipe tobacco, electronic 

nicotine delivery systems (ENDS), and 

other tobacco products as required by 

section 904(a)(4) of the FD&C Act, will 

take approximately 50 hours per 

submission based on the existing 

collection that applies to tobacco 

products currently subject to the FD&C 

Act and FDA experience. To derive the 

number of respondents for this 

provision, FDA assumes that very few 

manufacturers or importers of deemed 

tobacco products, or agents thereof, 

would have health documents to 

submit. In addition to the existing 4 

respondents, the Agency estimates that 

approximately 6 submissions (2 for cigar 

manufacturers, 1 for pipe and waterpipe 

tobacco manufacturers, 1 for other 

tobacco product manufacturers, 1 for 

tobacco importers, and 1 for importers 

of ENDS who are considered 

manufacturers) will be submitted on an 

annual basis for a total of 10 

respondents. FDA estimates the total 

annual reporting burden to be 1,600 

hours. 

Based on a review of the information 

collection of our current OMB approval, 

we have made no adjustments to our 

burden estimate. 

Dated: August 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18212 Filed 8–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2776] 

Evaluating Inclusion and Exclusion 

Criteria in Clinical Trials; Workshop 

Report; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency is 

announcing the availability of a 

summary report of a public workshop 

that was held on April 16, 2018, entitled 

‘‘Evaluating Inclusion and Exclusion 

Criteria in Clinical Trials.’’ The FDA 

Reauthorization Act of 2017 (FDARA) 

requires that the Agency convene a 

public workshop to discuss clinical trial 

eligibility criteria to inform a guidance 

on this subject and to publish a report 

summarizing the topics discussed 

within 90 days of the public workshop. 

This summary report fulfills FDA’s 

mandate under FDARA. 

ADDRESSES: For persons without 

internet access, copies of the summary 

report can be requested from the 

Division of Drug Information, Food and 

Drug Administration, by mail: 10001 

New Hampshire Ave, Silver Spring, MD 

20993–0002, or toll free telephone: 855– 

543–3784. 

FOR FURTHER INFORMATION CONTACT: 

Dianne Paraoan, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg 51, Rm. 3326, 

Silver Spring, MD 20993, 301–796– 

2500, Dianne.Paraoan@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 610 of FDARA requires that 

FDA convene a public workshop to 

discuss clinical trial eligibility criteria 

to inform a guidance on this subject and 

to publish a report summarizing the 

topics discussed within 90 days of the 

public workshop (Pub. L. 115–52). On 

April 16, 2018, FDA convened the 

public workshop required by FDARA 

entitled ‘‘Evaluating Inclusion and 

Exclusion Criteria in Clinical Trials.’’ 

This notice announces the availability 

of the report required by FDARA that 

summarizes the major points explored 

with stakeholders during the public 

workshop. The report is intended only 

as a summary of the workshop 


daltland on DSKBBV9HB2PROD with NOTICES