Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 46501 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3263] 

Request for Nominations for Voting 

Members on the Tobacco Products 

Scientific Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for members to serve on 

the Tobacco Products Scientific 

Advisory Committee, Office of Science, 

Center for Tobacco Products. 

FDA seeks to include the views of 

women and men, members of all racial 

and ethnic groups, and individuals with 

and without disabilities on its advisory 

committees and, therefore encourages 

nominations of appropriately qualified 

candidates from these groups. 

DATES: Nominations received on or 

before November 13, 2018 will be given 

first consideration for membership on 

the Tobacco Products Scientific 

Advisory Committee. Nominations 

received after November 13, 2018 will 

be considered for nomination to the 

committee as later vacancies occur. 

ADDRESSES: All nominations for 

membership should be sent 

electronically by logging into the FDA 

Advisory Nomination Portal: https://

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. 

FOR FURTHER INFORMATION CONTACT: 

Regarding all nomination questions for 

membership, the primary contact is: 

Caryn Cohen, Office of Science, Center 

for Tobacco Products, Food and Drug 

Administration, Document Control 

Center, 10903 New Hampshire Ave., 

Bldg. 71, Rm. G335, Silver Spring, MD 

20993–0002, 1–877–287–1373 (choose 

option 5), email: TPSAC@fda.hhs.gov. 

Information about becoming a 

member on an FDA advisory committee 

can also be obtained by visiting FDA’s 

website at: https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for voting 

members on the Tobacco Products 

Scientific Advisory Committee. 

I. General Description of the Committee 

Duties 

The Tobacco Products Scientific 

Advisory Committee (the Committee) 

advises the Commissioner of Food and 

Drugs (the Commissioner) or designee in 

discharging responsibilities related to 

the regulation of tobacco products. The 

Committee reviews and evaluates safety, 

dependence, and health issues relating 

to tobacco products and provides 

appropriate advice, information, and 

recommendations to the Commissioner. 

II. Criteria for Voting Members 

The Committee consists of 12 

members including the Chair. Members 

and the Chair are selected by the 

Commissioner or designee from among 

individuals knowledgeable in the fields 

of medicine, medical ethics, science, or 

technology involving the manufacture, 

evaluation, or use of tobacco products. 

Almost all non-Federal members of this 

committee serve as Special Government 

Employees. The Committee includes 

nine technically qualified voting 

members, selected by the Commissioner 

or designee. The nine voting members 

include seven members who are 

physicians, dentists, scientists, or 

healthcare professionals practicing in 

the area of oncology, pulmonology, 

cardiology, toxicology, pharmacology, 

addiction, or any other relevant 

specialty. The nine voting members also 

include one member who is an officer 

or employee of a State or local 

government or of the Federal 

Government, and one member who is a 

representative of the general public. 

Almost all non-Federal members of this 

committee serve as Special Government 

Employees. Members will be invited to 

serve for terms of up to 4 years. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified individuals for 

membership on the advisory committee. 

Self-nominations are also accepted. 

Nominations must include a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee and a signed copy of the 

Acknowledgement and Consent form 

available at the FDA Advisory 

Nomination Portal (see ADDRESSES). 

Nominations must also specify the 

advisory committee for which the 

nominee is recommended. Nominations 

must also acknowledge that the 

nominee is aware of the nomination 

unless self-nominated. FDA will ask 

potential candidates to provide detailed 

information concerning such matters 

related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflicts of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: September 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19921 Filed 9–12–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1588] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Exemptions From 

Substantial Equivalence Requirements 

for Tobacco Products 

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 exemptions from 

substantial equivalence requirements for 

tobacco products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 13, 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 November 13, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 13, 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: 


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46502 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 

• 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–1588 for ‘‘Exemptions From 

Substantial Equivalence Requirements 

for Tobacco Products.’’ 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 

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. 

Exemptions From Substantial 

Equivalence Requirements for Tobacco 

Products 

OMB Control Number 0910–0684— 

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 a 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. 

The FD&C Act, as amended by the 

Tobacco Control Act, requires that 

before a new tobacco product may be 

introduced or delivered for introduction 

into interstate commerce, the new 

tobacco product must undergo 

premarket review by FDA. FDA must 

issue an order authorizing the 

commercial distribution of the new 

tobacco product or find the product 

exempt from the requirements of 

substantial equivalence under section 

910(a)(2)(A) of the FD&C Act, before the 

product may be introduced into 

commercial distribution (section 910 of 

the FD&C Act (21 U.S.C. 387j)). 

The Tobacco Control Act also gave 

FDA the authority to issue a regulation 

deeming all other products that meet the 

statutory definition of a tobacco product 

to be subject to Chapter IX of the FD&C 

Act (section 901(b) (21 U.S.C. 387a(b)) 

of the FD&C Act). On May 10, 2016, 

FDA issued that rule, extending FDA’s 

tobacco product authority to all 

products that meet the definition of 

tobacco product in the law (except for 

accessories of newly regulated tobacco 

products), including electronic nicotine 

delivery systems, cigars, hookah, pipe 


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Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 46503 

tobacco, nicotine gels, dissolvables that 

were not already subject to the FD&C 

Act, and other tobacco products that 

may be developed in the future (81 FR 

28974 at 28976, May 10, 2016) (‘‘the 

final deeming rule’’)). 

FDA has established a pathway for 

manufacturers to request exemptions 

from the substantial equivalence 

requirements of the FD&C Act in 

§ 1107.1 (21 CFR 1107.1) of the 

Agency’s regulations. As described in 

§ 1107.1(a), FDA may exempt tobacco 

products that are modified by adding or 

deleting a tobacco additive, or 

increasing or decreasing the quantity of 

an existing tobacco additive, from the 

requirement of demonstrating 

substantial equivalence if the Agency 

determines that: (1) The modification 

would be a minor modification of a 

tobacco product that can be sold under 

the FD&C Act; (2) a report 

demonstrating substantial equivalence 

is not necessary to ensure that 

permitting the tobacco product to be 

marketed would be appropriate for the 

protection of public health; and (3) an 

exemption is otherwise appropriate. 

Section 1107.1(b) states that a request 

for exemption under section 905(j)(3) of 

the FD&C Act may be made only by the 

manufacturer of a legally marketed 

tobacco product for a minor 

modification to that tobacco product 

and that the manufacturer must submit 

the request and all information 

supporting it to FDA. The request must 

be made in an electronic format that 

FDA can process, review, and archive 

(or a written request must be made by 

the manufacturer explaining in detail 

why the manufacturer cannot submit 

the request in an electronic format and 

requesting an alternative means of 

submission to the electronic format). 

An exemption request must contain: 

(1) The manufacturer’s address and 

contact information; (2) identification of 

the tobacco product(s); (3) a detailed 

explanation of the purpose for the 

modification; (4) a detailed description 

of the modification, including a 

statement as to whether the 

modification involves adding or 

deleting a tobacco additive, or 

increasing or decreasing the quantity of 

the existing tobacco additive; (5) a 

detailed explanation of why the 

modification is a minor modification of 

a tobacco product that can be sold under 

the FD&C Act; (6) a detailed explanation 

of why a report under section 905(j)(1) 

of the FD&C Act intended to 

demonstrate substantial equivalence is 

not necessary to ensure that permitting 

the tobacco product to be marketed 

would be appropriate for protection of 

the public health; (7) a certification (i.e., 

a signed statement by a responsible 

official of the company) summarizing 

the supporting evidence and providing 

the rationale for the official’s 

determination that the modification 

does not increase the tobacco product’s 

appeal to or use by minors, toxicity, 

addictiveness, or abuse liability; (8) 

other information justifying an 

exemption; and (9) an environmental 

assessment (EA) under part 25 (21 CFR 

part 25) prepared in accordance with 

the requirements of § 25.40. 

The National Environmental Policy 

Act of 1969 (NEPA) (42 U.S.C. 4321– 

4347) states national environmental 

objectives and imposes upon each 

Federal Agency the duty to consider the 

environmental effects of its actions. 

Section 102(2)(C) of NEPA requires the 

preparation of an environmental impact 

statement for every major Federal action 

that will significantly affect the quality 

of the human environment. 

The FDA NEPA regulations are 

contained in part 25. All applications 

for exemption from substantial 

equivalence require the submission of 

an EA. An EA provides information that 

is used to determine whether an FDA 

action could result in a significant 

environmental impact. Section 25.40(a) 

and (c) specifies the content 

requirements for EAs for nonexcluded 

actions. 

The information required by 

§ 1107.1(b) is submitted to FDA so FDA 

can determine whether an exemption 

from substantial equivalence to the 

product is appropriate for the protection 

of the public health. Section 1107.1(c) 

states that FDA will review the 

information submitted and determine 

whether to grant or deny an exemption 

based on whether the criteria in section 

905(j)(3) of the FD&C Act are met. FDA 

may request additional information if 

necessary to make a determination and 

may consider the exemption request 

withdrawn if the information is not 

provided within the requested 

timeframe. 

Section 905(j)(1)(A)(ii) of the FD&C 

Act states that if an exemption has been 

requested and granted, a report must be 

submitted to FDA that demonstrates that 

the tobacco product is modified within 

the meaning of section 905(j)(3), the 

modifications are to a product that is 

commercially marketed and in 

compliance with the requirements of the 

FD&C Act, and all of the modifications 

are covered by exemptions granted by 

the Secretary of Health and Human 

Services (the Secretary) under section 

905(j)(3). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section and activity Number of 

respondents 

Number of 

responses per 

respondent 2

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

§ 1107.1(b) Optional Preparation of Tobacco Product Exemption From Substantial Equivalence Request Including § 25.40 Preparation of 

an Environmental Assessment 

21 CFR 1107.1(b)—Preparation of tobacco product exemption from substantial equivalence request and 21 

CFR 25.40—Preparation of an environmental assessment .................................................................................. 812 1 812 24 19,488 

Total Hours (§ 1107.1(b)) .............................................. ........................ ........................ ........................ ........................ 19,218 

§ 1107.1(c) Preparation of Additional Information for Tobacco Product Exemption From Substantial Equivalence Request 

21 CFR 1107.1(c)—Preparation of additional information 

for tobacco product exemption from substantial equivalence request .................................................................... 244 1 244 3 732 


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46504 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section and activity Number of 

respondents 

Number of 

responses per 

respondent 2

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

Total Hours (§ 1107.1(c)) .............................................. ........................ ........................ ........................ ........................ 732 

Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption granted, report submitted to demonstrate tobacco product is modified under section 905(j)(3), modifications are to a product that is commercially marketed and compliant, and modifications covered by exemptions granted by Secretary under section 905(j)(3) 

Abbreviated report submitted to demonstrate tobacco 

product is modified under section 905(j)(3), modifications are to a product that is commercially marketed and 

compliant, and modifications covered by exemptions 

granted by Secretary under section 905(j)(3) .................. 1217 1 1217 3 3,651 

Total Hours (section 905(j)(1)(A)(ii)) of the FD&C Act ........................ ........................ ........................ ........................ 3,651 

Total Hours Exemptions From Substantial Equivalence Requirements .................................................. ........................ ........................ ........................ ........................ 23,871 

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

FDA estimates that we will receive 

812 exemption requests under 

§ 1107.1(b) for 24 hours per response 

including EA for a total of 19,488 hours. 

Since an EA is required for each 

§ 1107.1(b) (Optional Preparation of 

Tobacco Product Exemption From 

Substantial Equivalence Request), the 

burden per response for EAs (12 hours) 

has been combined with the 12 hours 

for an SE request for a total of 24 hours 

per response. 

FDA further estimates that we will 

receive 244 submissions requiring 

additional information in support of the 

initial exemption request, and it is 

expected that it will take an average of 

3 hours to prepare the additional 

information for a total of 732 hours. 

FDA estimates that 1,217 respondents 

will prepare 1,217 responses and each 

response will take approximately 3 

hours to prepare, as required by section 

905(j)(1)(A)(ii) of the FD&C Act, for a 

total of 3,651 hours. 

This collection of information 

requires a manufacturer to submit a 

report at least 90 days prior to making 

an introduction or delivery for 

introduction into interstate commerce 

for commercial distribution of a tobacco 

product. Section 905(j)(1)(A)(ii) of the 

FD&C Act states that if an exemption 

has been requested and granted, the 

manufacturer must submit to FDA a 

report that demonstrates that the 

tobacco product is modified within the 

meaning of section 905(j)(3), the 

modifications are to a product that is 

commercially marketed and in 

compliance with the requirements of the 

FD&C Act, and all the modifications are 

covered by exemptions granted by the 

Secretary under section 905(j)(3). FDA 

estimates the total hours for exemptions 

from Substantial Equivalence 

Requirements will be 23,871 hours. 

FDA’s estimates are based on full 

analysis of economic impacts and 

information gathered from other FDAregulated products. Based on a review of 

the currently approved information 

collection, we have made no 

adjustments to our burden estimate. 

Dated: September 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19913 Filed 9–12–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Forms for Use With 

Applications to the Maternal and Child 

Health Bureau Research and Training 

Grants, OMB No. 0906—New 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate 

below or any other aspect of the ICR. 

DATES: Comments on this ICR must be 

received no later than November 13, 

2018. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Lisa Wright-Solomon, the HRSA 

Information Collection Clearance Officer 

at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

Forms for Use with Applications to the 

Maternal and Child Health Bureau 

Research and Training Grants, OMB No. 

0906–xxxx—New. 

Abstract: HRSA currently utilizes the 

National Institute of Health’s (NIH) 

Biographical Sketch and Public Health 

Service (PHS) Inclusion Enrollment 

forms (0925–0001) for HRSA’s SF424 

Research & Related application package 

research grants. In order to update the 

forms to meet HRSA’s needs, HRSA 

plans to remove the NIH-specific 

references and obtain its own OMB 

control number for the collection of this 

information. 

Need and Proposed Use of the 

Information: HRSA’s Maternal and 

Child Health Bureau (MCHB) plans to 

modify the Biographical Sketch and the 


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