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
Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45255 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the identification 

of a suspect product and the termination 

of notifications regarding an illegitimate 

product. 

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– 

2014–D–0609 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Guidance 

for Industry: Drug Supply Chain 

Security Act Implementation: 

Identification of Suspect Product and 

Notification.’’ 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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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: Drug Supply 

Chain Security Act Implementation: 

Identification of Suspect Product and 

Notification 

OMB Control Number 0910–0806— 

Extension 

This information collection supports 

the previously captioned Agency 

guidance and associated Form FDA 

3911. The Drug Supply Chain Security 

Act (DSCSA) (Title II of Pub. L. 113–54) 

added new section 582(h)(2) to the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), requiring FDA to issue 

guidance to aid trading partners in 

identifying a suspect product and 


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45256 Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 

terminating a notification regarding an 

illegitimate product and, for a 

manufacturer, a product with a high risk 

of illegitimacy. Suspect product is 

defined in section 581(21) of the FD&C 

Act as a product for which there is 

reason to believe it: (1) Is potentially 

counterfeit, diverted, or stolen; (2) is 

potentially intentionally adulterated 

such that the product would result in 

serious adverse health consequences or 

death to humans; (3) is potentially the 

subject of a fraudulent transaction; or (4) 

appears otherwise unfit for distribution 

such that the product would result in 

serious adverse health consequences or 

death to humans. 

Beginning January 1, 2015, section 

582 of the FD&C Act requires certain 

trading partners, upon determining that 

a product in their possession or control 

is a suspect product, to quarantine the 

product while they promptly conduct 

an investigation to determine whether 

the product is an illegitimate product. 

Illegitimate product is defined in 

section 581(8) of the FD&C Act as a 

product for which credible evidence 

shows that it: (1) Is counterfeit, diverted, 

or stolen; (2) is intentionally adulterated 

such that the product would result in 

serious adverse health consequences or 

death to humans; (3) is the subject of a 

fraudulent transaction; or (4) appears 

otherwise unfit for distribution such 

that the product would be reasonably 

likely to result in serious adverse health 

consequences or death to humans. Also 

beginning January 1, 2015, trading 

partners must, upon determining that a 

product in their possession or control is 

illegitimate, notify FDA and all 

immediate trading partners that they 

have reason to believe they may have 

received the illegitimate product not 

later than 24 hours after making the 

determination. Under section 

582(b)(4)(B)(ii)(II) of the FD&C Act, 

manufacturers are additionally required 

to notify FDA and any immediate 

trading partners that they believe may 

possess a product manufactured by or 

purportedly manufactured by the 

manufacturer not later than 24 hours 

after the determination is made or being 

notified by FDA or a trading partner that 

the product has a high risk of 

illegitimacy. 

Under section 202 of the DSCSA, 

manufacturers, repackagers, wholesale 

distributors, and dispensers (e.g., 

pharmacies) must: (1) Notify FDA when 

they have determined that a product in 

their possession or control is 

illegitimate (and, for manufacturers, 

when they have determined or been 

notified by FDA or a trading partner that 

a product has a high risk of 

illegitimacy); (2) notify certain 

immediate trading partners about an 

illegitimate product that they may have 

received (and, for manufacturers, that a 

product has a high risk of illegitimacy); 

(3) terminate notifications regarding 

illegitimate products (and, for 

manufacturers, a product with a high 

risk of illegitimacy), in consultation 

with FDA, when the notifications are no 

longer necessary; and (4) notify 

immediate trading partners when the 

notifications are terminated. Trading 

partners should use Form FDA 3911 to 

submit notifications and requests for 

terminations of notifications to FDA. 

Form FDA 3911 is available on FDA’s 

web page (https://www.accessdata.fda.

gov/scripts/cder/email/ 

drugnotification.cfm). 

A. Notifications to FDA 

Under section 582(b)(4)(B)(ii)(I), 

(c)(4)(B)(ii), (d)(4)(B)(ii), and (e)(4)(B)(ii) 

of the FD&C Act, as amended by the 

DSCSA, and beginning not later than 

January 1, 2015, a manufacturer, 

repackager, wholesale distributor, or 

dispenser who determines that a 

product in its possession or control is 

illegitimate must notify FDA of that 

determination not later than 24 hours 

after the determination is made. In 

addition, section 582(b)(4)(B)(ii)(II) of 

the FD&C Act requires manufacturers to 

notify FDA when a manufacturer 

determines that a product poses a high 

risk of illegitimacy. 

We originally estimated that all 

manufacturers, repackagers, wholesale 

distributors, and dispensers would 

collectively submit 5,000 notifications 

per year. This estimate included the 

notifications by trading partners that 

have determined that illegitimate 

product is in their possession or control, 

as well as notifications by 

manufacturers that have determined a 

product poses a high risk of 

illegitimacy. As discussed in our 

Federal Register notice of June 11, 2014 

(79 FR 33564), the estimate was based 

on our experience with field alert 

reports (FARs) (Form FDA 3331) that 

holders of approved drug applications 

are required to submit for certain drug 

quality issues (21 CFR 314.81(b)(1)) and 

with reports of the falsification of drug 

sample records, diversion, loss, and 

known theft of prescription drug 

samples as currently required under 

§ 203.37 (21 CFR 203.37). Upon 

evaluation of the number of 

notifications we received for fiscal years 

2016 and 2017, however, we are 

lowering our estimate to 150 

notifications. 

We are also combining the estimates 

for manufacturers and repackagers 

because FDA’s establishment and drug 

product listing database indicates that 

many companies perform activities of 

both manufacturers and repackagers. 

Although the DSCSA specifically 

defines dispensers, for estimation 

purposes, we are using estimates for 

pharmacies in general terms based on 

those that must comply with the new 

requirements under section 582(d) of 

the FD&C Act. 

Because manufacturers, repackagers, 

and wholesale distributors are 

collectively responsible for prescription 

drugs from the point of manufacturing 

through distribution in the drug supply 

chain, we assume that most 

notifications of illegitimate products are 

submitted by these three trading 

partners. The total number of 

respondents is comprised of 80 percent 

manufacturers (120), 15 percent 

wholesale distributors (22), and 5 

percent pharmacies (8). 

We estimate that the number of 

annual notifications will vary from 0 to 

2 for manufacturers/repackagers, as well 

as from pharmacies, with the vast 

majority of companies making no 

notifications. Although FDA’s 

establishment and drug product listing 

database currently contains registrations 

for approximately 6,500 manufacturers 

and repackagers, we estimate that 

approximately 120 manufacturers/ 

repackagers will notify us of illegitimate 

products an average of one time per 

year. Although we estimate 

approximately 69,000 pharmacy sites in 

the United States, based on data from 

the National Association of Chain Drug 

Stores, the National Community 

Pharmacists Association, and the 

American Hospital Association, we 

estimate that approximately 8 

pharmacies will notify FDA of 

illegitimate product an average of one 

time per year. According to the 

Healthcare Distribution Alliance 

(formerly known as Healthcare 

Distribution Management Association), 

approximately 30 wholesale distributors 

are responsible for over 90 percent of 

drug distributions; based on sales and 

because FDA is estimating that over 

2,200 small wholesale distributors 

might be responsible for the remaining 

10 percent of drug sales, we estimate 

that wholesale distributors will be 

responsible for making about an average 

of 1 notification per year to account for 

the estimated 22 notifications that FDA 

will receive regarding illegitimate 

product. Each notification should 

include information about the person or 

entity initiating the notification, the 

product determined to be illegitimate or 

having a high risk of illegitimacy, and 

a description of the circumstances 

surrounding the event that prompted 


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the notification. We estimate that each 

notification will take about 1 hour, as 

reflected in table 1. 

B. Notifications to Trading Partners of 

an Illegitimate Product or Product With 

a High Risk of Illegitimacy 

Under section 582(b)(4)(B)(ii)(I), 

(c)(4)(B)(ii), (d)(4)(B)(ii), and (e)(4)(B)(ii) 

of the FD&C Act, a trading partner who 

determines that a product in its 

possession is illegitimate must also 

notify all immediate trading partners 

that they believe may have received 

such illegitimate product not later than 

24 hours after the determination is 

made. In addition, under section 

582(b)(4)(B)(ii)(II) of the FD&C Act, a 

manufacturer is required to notify all 

immediate trading partners that the 

manufacturer believes may possess a 

product manufactured by or purported 

to be manufactured by the manufacturer 

not later than 24 hours after the 

determination is made or being notified 

by FDA or a trading partner that the 

product has a high risk of illegitimacy. 

Because the extent of distribution of 

any illegitimate product is likely to vary 

from one situation to another, we 

assume a wide distribution of each 

illegitimate product. We estimate that, 

for each notification made by a 

manufacturer or repackager to FDA, 

approximately 30 trading partners 

(based on the number of distributors) 

will also be notified. This results in 

approximately 3,600 notifications 

annually to trading partners of 

manufacturers/repackagers. This 

estimate includes the notifications by 

manufacturers and repackagers who 

have determined that illegitimate 

product is in their possession or control, 

as well as notifications by 

manufacturers that have determined 

that a product poses a high risk of 

illegitimacy. 

We estimate that a large wholesale 

distributor may have up to 4,500 trading 

partners, but a small wholesale 

distributor may have 200 trading 

partners, for an average of 

approximately 2,350. We originally 

estimated that a wholesale distributor 

would notify all 2,350 trading partners 

for each of the illegitimate products 

identified. However, we are lowering 

our estimate as a result of our 

experience with the collection and 

informal feedback from industry to 

reflect that 22 respondents will make 

1,175 disclosures for a total of 25,850 

disclosures annually; and that each 

disclosure will require approximately 

12 minutes, for a total of 5,170 hours 

annually. 

We estimate that a pharmacy 

purchases prescription drugs from an 

average of two wholesale distributors. 

Therefore, a pharmacy would notify 2 

trading partners for each of the 8 

illegitimate products identified, 

resulting in approximately 16 

notifications annually to pharmacy 

trading partners. 

Manufacturers/repackagers, wholesale 

distributors, and pharmacies may notify 

their trading partners using existing 

systems and processes used for similar 

types of communications. Such 

communications may include, but are 

not limited to, posting notifications on 

a company website, sending an email, 

telephoning, or mailing or faxing a letter 

or notification. The information 

contained in the notification to the 

immediate trading partner should be the 

same as or based on the notification that 

was already submitted to FDA. We 

estimate that, for all trading partners, 

each notification of immediate trading 

partners will take approximately 0.2 

hours (12 minutes). The estimated total 

burden hours that manufacturers/ 

repackagers, wholesale distributors, and 

pharmacies will take to notify trading 

partners is approximately 5,893 hours 

annually, as reflected in table 2. 

C. Consultations With FDA and 

Termination of Notification 

Section 582(b)(4)(B)(iv), (c)(4)(B)(iv), 

(d)(4)(B)(iv), and (e)(4)(B)(iv) of the 

FD&C Act requires that a trading partner 

who determines, in consultation with 

FDA, that a notification made under 

section 582(b)(4)(B)(ii), (c)(4)(B)(ii), 

(d)(4)(B)(ii), or (e)(4)(B)(ii) is no longer 

necessary must terminate the 

notification. The guidance for industry 

sets forth the process by which trading 

partners should consult with FDA to 

terminate notifications that are no 

longer necessary. 

Each request for termination of 

notification must include information 

about the person or entity initiating the 

request for termination, the illegitimate 

product or product with a high risk of 

illegitimacy, the notification that was 

issued, and an explanation about what 

actions have taken place or what 

information has become available that 

make the notification no longer 

necessary. Trading partners should also 

include the FDA-assigned incident 

number associated with the initial 

notification on the request for 

termination. The request for a 

termination will be viewed as a request 

for consultation with FDA. We estimate 

that the same amount of time will be 

required to provide the information 

necessary to request termination as is 

required to make the notification. The 

time required to investigate and resolve 

an illegitimate product notification will 

vary, but we assume that each 

notification will eventually be 

terminated. We assume that the number 

of requests for termination of a 

notification per year will be the same as 

the original number of notifications for 

a given year. The estimated total burden 

hours of making requests for 

termination of notifications to FDA is 

150 hours annually, as reflected in table 

3. 

D. Notifications to Trading Partners 

That a Notification Has Been 

Terminated 

Section 582(b)(4)(B)(iv), (c)(4)(B)(iv), 

(d)(4)(B)(iv), and (e)(4)(B)(iv) of the 

FD&C Act requires that a trading partner 

who, in consultation with FDA, 

terminates a notification made under 

section 582(b)(4)(B)(ii)(I) or (II), 

(c)(4)(B)(ii), (d)(4)(B)(ii), or (e)(4)(B)(ii) 

must also promptly inform previouslynotified immediate trading partners that 

the notification has been terminated. We 

estimate that the burden for notifying 

trading partners of an illegitimate 

product and the number of trading 

partners notified will be the same as the 

estimates for notification of termination. 

The estimated total burden hours of 

notifying trading partners that the 

notification is terminated is 

approximately 5,893 hours annually, as 

reflected in table 4. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—NOTIFICATIONS TO FDA 1

Respondent description Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Manufacturers and Repackagers ......................................... 120 1 120 1 120 

Wholesale Distributors ......................................................... 22 1 22 1 22 

Dispensers ........................................................................... 8 1 8 1 8 


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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—NOTIFICATIONS TO FDA 1—Continued 

Respondent description Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total .............................................................................. ........................ ........................ ........................ ........................ 150 

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

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NOTIFICATIONS TO TRADING PARTNERS OF AN

ILLEGITIMATE PRODUCT 1

Respondent description Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Manufacturers and Repackagers ......................... 120 30 3,600 0.20 (12 minutes) ......... 720 

Wholesale Distributors .......................................... 22 1,175 25,850 0.20 (12 minutes) ......... 5,170 

Dispensers ............................................................ 8 2 16 0.20 (12 minutes) ......... 3.2 

Total ............................................................... ........................ ........................ ........................ ....................................... 5,893 

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

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR CONSULTATION WITH FDA AND TERMINATION OF NOTIFICATION 1

Respondent description Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Manufacturers and Repackagers ......................................... 120 1 120 1 120 

Wholesale Distributors ......................................................... 22 1 22 1 22 

Dispensers ........................................................................... 8 1 8 1 8 

Total .............................................................................. ........................ ........................ ........................ ........................ 150 

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

TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NOTIFICATIONS TO TRADING PARTNERS OF AN

ILLEGITIMATE PRODUCT TERMINATION 1

Respondent description Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Manufacturers and Repackagers ......................... 120 30 3,600 0.2 (12 minutes) ........... 720 

Wholesale Distributors .......................................... 22 1,175 25,850 0.2 (12 minutes) ........... 5,170 

Dispensers ............................................................ 8 2 16 0.2 (12 minutes) ........... 3.2 

Total ............................................................... ........................ ........................ ........................ ....................................... 5,893 

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

Cumulatively, the total estimated 

burden is 12,086 annual hours, which 

reflects a significant decrease. We base 

this adjustment on our experience with 

the information collection since its 

establishment and implementation. 

Dated: August 31, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19351 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–3207] 

Request for Nominations of Voting 

Members on a Public Advisory 

Committee; National Mammography 

Quality Assurance Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting members to 

serve on the National Mammography 

Quality Assurance Advisory Committee 

in the Center for Devices and 

Radiological Health. Nominations will 

be accepted for upcoming vacancies 

effective with this notice. 

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 5, 2018, will be given 

first consideration for membership on 

the National Mammography Quality 


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