Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45251 

SIX DRAFT GUIDANCES PUBLISHED JULY 12, 2018—Continued 

Docket No. Draft guidance document title FR cite 

FDA–2018–D–2258 ........ Human Gene Therapy for Rare Diseases; Draft Guidance for Industry ................................................. 83 FR 32303 

The Agency has received requests for 

a 60-day extension of the comment 

period for the six draft guidance 

documents. These requests conveyed 

concern that the current 90-day 

comment period does not allow 

sufficient time to develop a meaningful 

or thoughtful response to the draft 

guidance documents. 

FDA has considered these requests 

and is extending the comment period 

for the six draft guidance documents for 

60 days, until December 10, 2018. The 

Agency believes that a 60-day extension 

allows adequate time for interested 

persons to submit comments. 

II. References 

The following references are on 

display in the Dockets Management 

Staff (see ADDRESSES) and are available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; they are also available 

electronically at https://

www.regulations.gov. 

1. Letter from Robert Falb, Director, U.S. 

Policy and Advocacy, Alliance for 

Regenerative Medicine, to Dr. Peter 

Marks, Director, Center for Biologics 

Evaluation and Research, FDA (July 23, 

2018). 

2. Letter from Sesquile Ramon, Ph.D., 

Director, Science and Regulatory Affairs, 

Biotechnology Innovation Organization, 

to FDA Dockets Management Staff 

(August 3, 2018). 

Dated: August 29, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19303 Filed 9–5–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0147] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry and Food and Drug 

Administration Staff; Section 905(j) 

Reports: Demonstrating Substantial 

Equivalence 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 ‘‘Guidance for 

Industry and Food and Drug 

Administration Staff; Section 905(j) 

Reports: Demonstrating Substantial 

Equivalence for Tobacco Products.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 5, 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 5, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 5, 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– 

2011–D–0147 for ‘‘Guidance for 

Industry and Food and Drug 

Administration Staff; Section 905(j) 

Reports: Demonstrating Substantial 

Equivalence 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 


daltland on DSKBBV9HB2PROD with NOTICES
45252 Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 

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. 

Guidance for Industry and Food and 

Drug Administration Staff on Section 

905(j) Reports: Demonstrating 

Substantial Equivalence for Tobacco 

Products 

OMB Control Number 0910–0673— 

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 chapter granting FDA 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)). 

FDA has issued a guidance document 

containing recommendations for 

preparing substantial equivalence 

reports (SE Reports) under section 

905(j)(1)(A)(i). A tobacco product 

manufacturer must show that a new 

tobacco product is substantially 

equivalent, within the meaning of 

section 910, to a tobacco product 

commercially marketed (other than for 

test marketing) in the United States as 

of February 15, 2007, or to a tobacco 

product that the Secretary has 

previously determined, pursuant to 

subsection (a)(3) of section 910, is 

substantially equivalent and that it is in 

compliance with the requirements of the 

FD&C Act. The comparison product 

chosen by the tobacco product 

manufacturer is referred to by FDA as 

the predicate tobacco product. 

The guidance document associated 

with this collection of information 

contains recommendations on preparing 

reports intended to demonstrate 

substantial equivalence to a predicate 

tobacco product and compliance with 

the FD&C Act as required under section 

905(j)(1)(A)(i). Submission of a section 

905(j)(1)(A)(i) report intended to 

demonstrate substantial equivalence 

and, in response, an order from the 

Agency finding that the new tobacco 

product is substantially equivalent to a 

predicate tobacco product and in 

compliance with the requirements of the 

FD& C Act, is one means for a new 

tobacco product to legally enter the 

market. FDA’s guidance entitled 

‘‘Demonstrating the Substantial 

Equivalence of a New Tobacco Product: 

Responses to Frequently Asked 

Questions’’ (December 2016). This 

guidance may be accessed at https://

www.fda.gov/TobaccoProducts/ 

Labeling/RulesRegulationsGuidance/ 

default.htm). In that guidance, FDA 

recommends that certain modifications 

might be addressed in a ‘‘Product 

Quantity Change Report,’’ which is a 

more streamlined SE Reports for certain 

modifications that should be easier for 

manufacturers to prepare. 

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 

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) (‘‘the Deeming final 

rule’’). 

FDA estimates the burden of this 

collection of information as follows: 


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Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45253 

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 

Full SE 905(j)(1)(A)(i) and 910(a) ........................................ 683 1 683 300 204,900 

Full SE 905(j)(1)(A)(i) and 910(a) Bundled ......................... 456 1 456 90 41,040 

Product Quantity Change SE Report .................................. 239 1 239 87 20,793 

Product Quantity Change Bundled SE Report .................... 192 1 192 62 11,904 

Total .............................................................................. ........................ ........................ ........................ ........................ 278,637 

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

FDA’s estimates are based on 

experience with SE Reports, initial 

updated deemed registration and listing 

data, interactions with the industry, and 

information related to other regulated 

products. The estimated number of SE 

Reports is expected to increase from an 

annual average of 979 to 1,570. 

When groups of full or product 

quantity change SE Reports have 

identical content, they may be bundled; 

when a group of similar reports are 

bundled, the subsequent bundled 

reports are expected to take less time to 

prepare than the initial report. 

FDA has based these estimates on 

information it now has available from 

interactions with the industry, 

information related to other regulated 

products, and FDA expectations 

regarding the tobacco industry’s use of 

the section 905(j) pathway to market 

their products. Table 1 describes the 

annual reporting burden as a result of 

the implementation of the substantial 

equivalence requirements of sections 

905(j)(1)(A)(i) and 910(a) of the FD&C 

Act (21 U.S.C. 387j(a)) for an SE 

application. 

FDA estimates that 683 respondents 

will prepare and submit 683 section 

905(j)(1)(A)(i) SE Reports each year. In 

addition, anyone submitting an SE 

Report is required to submit an 

environmental assessment (EA) under 

21 CFR 25.40. The burden for 

environmental reports has been 

included in the burden per response for 

each type of SE report. Based on FDA’s 

experience with EAs for currently 

regulated tobacco products, we expect 

industry to spend 80 hours to prepare 

an environmental assessment for a SE 

Report. Thus, FDA estimates that it will 

take a manufacturer approximately 300 

hours per report to prepare an SE Report 

and the EA for a new tobacco product, 

which is a total of 204,900 hours. 

In addition, we estimate receiving 456 

Full SE Bundled Reports at 90 hours per 

submission for a total of 41,040 hours. 

FDA estimates that it will receive 239 

Product Quantity Change SE Reports 

and that it will take a manufacturer 

approximately 87 hours to prepare this 

report for a total of 20,793 hours. This 

includes time to prepare the 

environmental assessment, which FDA 

believes will take less time due to the 

typically more limited modification(s) 

included in a Product Quantity Change 

SE Report. We estimate receiving 192 

Product Quantity Change Bundled SE 

Reports at approximately 62 hours per 

submission for a total of 11,904 hours, 

this number excludes the time for the 

initial SE Report which was previously 

account for. 

Therefore, FDA estimates the burden 

for submission of SE information will be 

278,637 hours. This is an increase of 

106,759 hours from the currently 

approved burden. We attribute this 

increase to an increase in the number of 

SE Reports we expect related to Deemed 

products (e.g., based on the initial 

registration and listing information). 

Dated: August 31, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19353 Filed 9–5–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3179] 

Request for Nominations on Public 

Advisory Panels of the Medical 

Devices Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting that 

any industry organizations interested in 

participating in the selection of 

nonvoting industry representatives to 

serve on certain panels of the Medical 

Devices Advisory Committee (MDAC or 

Committee) in the Center for Devices 

and Radiological Health (CDRH) notify 

FDA in writing. FDA is also requesting 

nominations for nonvoting industry 

representatives to serve on certain 

device panels of the MDAC in the 

CDRH. A nominee may either be selfnominated or nominated by an 

organization to serve as a nonvoting 

industry representative. Nominations 

will be accepted for current and 

upcoming vacancies effective with this 

notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

FDA by October 9, 2018 (see sections I 

and II of this document for further 

details). Concurrently, nomination 

materials for prospective candidates 

should be sent to FDA by October 9, 

2018. 

ADDRESSES: All statements of interest 

from industry organizations interested 

in participating in the selection process 

of nonvoting industry representative 

nomination should be sent to Margaret 

Ames (see FOR FURTHER INFORMATION

CONTACT). All nominations for 

nonvoting industry representatives 

should be submitted electronically by 

accessing the FDA Advisory Committee 

Membership 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. Information about 

becoming a member of an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Margaret Ames, Division of Workforce 

Management, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5264, Silver Spring, 

MD 20993, 301–796–5960, Fax: 301– 

847–8505, email: margaret.ames@

fda.hhs.gov. 


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