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. 


daltland on DSKBBV9HB2PROD with NOTICES
45254 Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 

SUPPLEMENTARY INFORMATION: The 

Agency is requesting nominations for 

nonvoting industry representatives to 

the panels listed in the table in this 

document. 

I. Medical Devices Advisory Committee 

The Committee reviews and evaluates 

data on the safety and effectiveness of 

marketed and investigational devices 

and makes recommendations for their 

regulation. The panels engage in a 

number of activities to fulfill the 

functions the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) envisions for 

device advisory panels. With the 

exception of the Medical Devices 

Dispute Resolution Panel, each panel, 

according to its specialty area, advises 

the Commissioner of Food and Drugs 

(the Commissioner) regarding 

recommended classification or 

reclassification of devices into one of 

three regulatory categories; advises on 

any possible risks to health associated 

with the use of devices; advises on 

formulation of product development 

protocols; reviews premarket approval 

applications for medical devices; 

reviews guidelines and guidance 

documents; recommends exemption of 

certain devices from the application of 

portions of the FD&C Act; advises on the 

necessity to ban a device; and responds 

to requests from the Agency to review 

and make recommendations on specific 

issues or problems concerning the safety 

and effectiveness of devices. With the 

exception of the Medical Devices 

Dispute Resolution Panel, each panel, 

according to its specialty area, may also 

make appropriate recommendations to 

the Commissioner on issues relating to 

the design of clinical studies regarding 

the safety and effectiveness of marketed 

and investigational devices. The 

Committee also provides 

recommendations to the Commissioner 

or designee on complexity 

categorization of in vitro diagnostics 

under the Clinical Laboratory 

Improvement Amendments of 1988. 

Dental Products Panel (two representatives—one to represent the 

medical device industry, and one to represent the dental drug industry).

Reviews and evaluates data concerning the safety and effectiveness of 

marketed and investigational products for use in dentistry, 

endodontics, or bone physiology relative to the oral and maxillofacial 

area and makes appropriate recommendations to the Commissioner 

of Food and Drugs. 

Immunology Devices Panel ...................................................................... Reviews and evaluates data concerning the safety and effectiveness of 

marketed and investigational in vitro devices for use in clinical laboratory medicine including oncology, immunology, and allergy and 

makes appropriate recommendations to the Commissioner of Food 

and Drugs. 

II. Qualifications 

Persons nominated for the device 

panels should be full-time employees of 

firms that manufacture products that 

would come before the panel, or 

consulting firms that represent 

manufacturers, or have similar 

appropriate ties to industry. 

III. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document (see DATES). Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations; 

and a list of all nominees along with 

their current resumes. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

nonvoting member to represent industry 

interests for a particular device panel. 

The interested organizations are not 

bound by the list of nominees in 

selecting a candidate. However, if no 

individual is selected within 60 days, 

the Commissioner will select the 

nonvoting member to represent industry 

interests. 

IV. Application Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. Nomination 

must include a current, complete 

re ́sume ́ or curriculum vitae for each 

nominee including current business 

address and telephone number, email 

address if available, and a signed copy 

of the Acknowledgement and Consent 

form available at the FDA Advisory 

Committee Membership Nomination 

Portal (see ADDRESSES) within 30 days of 

publication of this document (see 

DATES). Nominations must also specify 

the advisory panel for which the 

nominee is recommended. Nominations 

must also acknowledge that the 

nominee is aware of the nomination 

unless self-nominated. FDA will 

forward all nominations to the 

organizations expressing interest in 

participating in the selection process for 

the particular device panels listed in the 

table. (Persons who nominate 

themselves as nonvoting industry 

representatives will not participate in 

the selection process). 

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. 

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: August 31, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19350 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–2014–D–0609] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry: Drug Supply Chain Security 

Act Implementation: Identification of 

Suspect Product and Notification 

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 


daltland on DSKBBV9HB2PROD with NOTICES