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Harmonisation; Draft Guidance for 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
50434 Federal Register / Vol. 82, No. 209 / Tuesday, October 31, 2017 / Notices 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002, or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 71, 

Rm. 3128, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Thomas 

Permutt, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 21, Rm. 3614, Silver Spring, 

MD 20993–0002, 301–796–1271; or John 

Scott, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 1018, Silver Spring, 

MD 20993–0002, 240–402–8779. 

Regarding the ICH: Amanda Roache, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1176, Silver Spring, 

MD 20993–0002, 301–796–4548. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, regulatory authorities 

and industry associations from around 

the world have participated in many 

important initiatives to promote 

international harmonization of 

regulatory requirements under the ICH. 

FDA has participated in several ICH 

meetings designed to enhance 

harmonization, and FDA is committed 

to seeking scientifically based 

harmonized technical procedures for 

pharmaceutical development. One of 

the goals of harmonization is to identify 

and reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was established to provide an 

opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products for human use 

among regulators around the world. The 

six founding members of the ICH are the 

European Commission; the European 

Federation of Pharmaceutical Industries 

Associations; FDA; the Japanese 

Ministry of Health, Labour, and Welfare; 

the Japanese Pharmaceutical 

Manufacturers Association; and the 

Pharmaceutical Research and 

Manufacturers of America. The 

Standing Members of the ICH 

Association include Health Canada and 

Swissmedic. Any party eligible as a 

Member in accordance with the ICH 

Articles of Association can apply for 

membership in writing to the ICH 

Secretariat. The ICH Secretariat, which 

coordinates the preparation of 

documentation, operates as an 

international nonprofit organization and 

is funded by the Members of the ICH 

Association. 

The ICH Assembly is the overarching 

body of the Association and includes 

representatives from each of the ICH 

members and observers. The Assembly 

is responsible for the endorsement of 

draft guidelines and adoption of final 

guidelines. FDA publishes ICH 

guidelines as FDA guidance. 

In July 2017, the ICH Assembly 

endorsed the draft guideline entitled 

‘‘E9(R1) Statistical Principles for 

Clinical Trials: Addendum: Estimands 

and Sensitivity Analysis in Clinical 

Trials’’ and agreed that the guidance 

should be made available for public 

comment. The draft guidance is the 

product of the Efficacy Expert Working 

Group of the ICH. Comments about this 

draft will be considered by FDA and the 

Efficacy Expert Working Group. 

The draft guidance provides guidance 

on aligning the choice of statistical 

methods with the goals of a clinical 

trial; on communicating the rationale for 

such choices to FDA; and on using 

sensitivity analysis to characterize the 

robustness of the conclusions to 

plausible deviations from the 

assumptions of the main analysis. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘E9(R1) Statistical Principles for 

Clinical Trials: Addendum: Estimands 

and Sensitivity Analysis in Clinical 

Trials.’’ It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. This guidance is not 

subject to Executive Order 12866. 

II. Electronic Access 

Persons with access to the internet 

may obtain the document at https://

www.regulations.gov, https://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, or https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm. 

Dated: October 26, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23613 Filed 10–30–17; 8:45 am] 

BILLING CODE 4164–01–P 


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