Federal Register / Vol. 82, No. 209 / Tuesday, October 31, 2017 / Notices 50431 

Further discussion is needed regarding 

(1) the role of packaging, storage, and 

disposal options within the larger 

landscape of activities aimed at 

addressing opioid abuse, misuse, or 

inappropriate access; (2) guiding 

principles and considerations for the 

design of packaging, storage, and 

disposal options for opioids; (3) 

integrating packaging, storage, and 

disposal options into existing health 

care and pharmacy systems, including 

both open and closed health care 

systems (e.g., a closed system such as 

the U.S. Department of Veterans 

Affairs); (4) data needs and how to 

address challenges in assessing the 

impact of packaging, storage, and 

disposal options in both the premarket 

and postmarket settings; and (5) ways in 

which FDA could encourage the 

development and assessment of 

packaging, storage, and disposal options 

for opioids that have the potential to 

enhance opioid safety. 

Participants will include individuals 

from a broad set of Federal, State, and 

private and public stakeholders who are 

working on the challenges of improving 

pain management while addressing the 

opioid abuse epidemic. Public 

participation and comment is 

encouraged. 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, ‘‘Packaging, Storage, and 

Disposal Options to Enhance Opioid 

Safety—Exploring the Path Forward,’’ 

please visit the following Web site to 

register: https://

nakamotoevents.wufoo.com/forms/ 

pads-task-force-public-meeting/. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public workshop must 

register by December 1, 2017, midnight 

Eastern Time. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. Registrants will receive 

confirmation when they have been 

accepted. If time and space permit, 

onsite registration on the day of the 

public workshop will be provided 

beginning at 7:30 a.m. We will let 

registrants know if registration closes 

before the day of the public workshop. 

If you need special accommodations 

due to a disability, please contact 

Michelle Eby at Michelle.Eby@

fda.hhs.gov no later than December 4, 

2017. 

Public Participation in Scientific 

Workshop: Time will be provided 

during the discussion of each agenda 

topic for audience participants to 

provide comments if desired. Comments 

should be specific to the discussion 

topic, and the time provided will be at 

the discretion of the session chair. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be webcast. Additional information 

will be made available regarding 

accessing the webcast 2 days prior to the 

public workshop at https://

www.fda.gov/Drugs/NewsEvents/ 

ucm571797.htm. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

workshop is available, it will be 

accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (see 

ADDRESSES). A link to the transcript will 

also be available on the internet at 

https://www.fda.gov/Drugs/NewsEvents/ 

ucm571797.htm. 

Dated: October 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23535 Filed 10–30–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No FDA–2008–D–0610] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on Postmarketing Adverse 

Event Reporting for Medical Products 

and Dietary Supplements During an 

Influenza Pandemic 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the 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 the information 

collection in the guidance on 

‘‘Postmarketing Adverse Event 

Reporting for Medical Products and 

Dietary Supplements During an 

Influenza Pandemic.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 2, 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 January 2, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of January 2, 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
50432 Federal Register / Vol. 82, No. 209 / Tuesday, October 31, 2017 / Notices 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2008–D–0610 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Guidance 

for Industry on Postmarketing Adverse 

Event Reporting for Medical Products 

and Dietary Supplements During an 

Influenza Pandemic.’’ 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 on 

Postmarketing Adverse Event Reporting 

for Medical Products and Dietary 

Supplements During an Influenza 

Pandemic 

OMB Control Number 0910–0701— 

Extension 

This information collection supports 

the above captioned Agency guidance. 

The guidance includes 

recommendations for planning, 

notification, and documentation for 

firms that report postmarketing adverse 

events. The guidance recommends that 

each firm’s pandemic influenza 

continuity of operations plan (COOP) 

include instructions for reporting 

adverse events, including a plan for the 

submission of stored reports that were 

not submitted within regulatory 

timeframes. The guidance explains that 

firms that are unable to fulfill normal 

adverse event reporting requirements 

during an influenza pandemic should: 

(1) Maintain documentation of the 

conditions that prevent them from 

meeting normal reporting requirements; 

(2) notify the appropriate FDA 

organizational unit responsible for 

adverse event reporting compliance 

when the conditions exist and when the 

reporting process is restored; and (3) 

maintain records to identify what 

reports have been stored. 

Based on the number of 

manufacturers that would be covered by 

the guidance, we estimate that 

approximately 5,000 firms will add the 

following to their COOP: (1) Instructions 

for reporting adverse events and (2) a 

plan for submitting stored reports that 

were not submitted within regulatory 

timeframes. We estimate that each firm 

will take approximately 50 hours to 

prepare the adverse event reporting plan 

for its COOP. 

We estimate that approximately 500 

firms will be unable to fulfill normal 

adverse event reporting requirements 

because of conditions caused by an 

influenza pandemic and that these firms 

will notify the appropriate FDA 

organizational unit responsible for 

adverse event reporting compliance 

when the conditions exist. Although we 

do not anticipate such pandemic 

influenza conditions to occur every 

year, for purposes of the PRA, we 

estimate that each of these firms will 

notify FDA approximately once each 

year and that each notification will take 

approximately 8 hours to prepare and 

submit. 

Concerning the recommendation in 

the guidance that firms unable to fulfill 

normal adverse event reporting 

requirements maintain documentation 

of the conditions that prevent them from 

meeting these requirements and also 

maintain records to identify what 

adverse event reports have been stored 

and when the reporting process is 

restored, we estimate that 

approximately 500 firms will each need 

approximately 8 hours to maintain the 

documentation and that approximately 

500 firms will each need approximately 

8 hours to maintain the records. 

We therefore estimate the burden of 

the collection of information as follows: 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 209 / Tuesday, October 31, 2017 / Notices 50433 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of reporting Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Notify FDA when normal reporting is not feasible ............... 500 1 500 8 4,000 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Type of recordkeeping Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Hours per 

record Total hours 

Add adverse event reporting plan to COOP ....................... 5,000 1 5,000 50 250,000 

Maintain documentation of influenza pandemic conditions 

and resultant high absenteeism ....................................... 500 1 500 8 4,000 

Maintain records to identify what reports have been stored 

and when the reporting process was restored ................ 500 1 500 8 4,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 258,000 

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

Based on our experience with the 

information collection we have retained 

our current burden estimate of 258,000 

hours annually. 

Dated: October 26, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23659 Filed 10–30–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6113] 

E9(R1) Statistical Principles for Clinical 

Trials: Addendum: Estimands and 

Sensitivity Analysis in Clinical Trials; 

International Council for 

Harmonisation; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance entitled ‘‘E9(R1) Statistical 

Principles for Clinical Trials: 

Addendum: Estimands and Sensitivity 

Analysis in Clinical Trials.’’ The draft 

guidance was prepared under the 

auspices of the International Council for 

Harmonisation (ICH), formerly the 

International Conference on 

Harmonisation. The draft guidance 

clarifies, updates, and extends the 

earlier ‘‘E9 Statistical Principles for 

Clinical Trials’’ in two main areas. 

Concerning estimands, it provides a 

framework for discussion of how the 

aims of a trial relate to the proposed 

statistical analysis. Concerning 

sensitivity analysis, it discusses how to 

use additional analyses to address 

concerns about the validity of 

assumptions underlying the main 

analysis. The draft guidance is intended 

to better align the choice of statistical 

methods with questions of regulatory 

importance and to improve the 

reliability of decisions about and 

representations of the effects of medical 

products. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 30, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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– 

2017–D–6113 for ‘‘E9(R1) Statistical 

Principles for Clinical Trials: 

Addendum: Estimands and Sensitivity 

Analysis in Clinical Trials; International 

Council for Harmonisation; Guidance 

for Industry; Availability.’’ Received 

comments 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 

office 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES