46078 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 

the docket (see the ADDRESSES section) 

on or before October 17, 2017, will be 

provided to the committees. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before October 

6, 2017. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by October 10, 2017. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require special accommodations 

due to a disability, please contact 

Kalyani Bhatt at least 7 days in advance 

of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 27, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21171 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5139] 

M4 Organization of the Common 

Technical Document for the 

Registration of Pharmaceuticals for 

Human Use; International Council for 

Harmonisation; 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 

guidance for industry (GIF) entitled ‘‘M4 

Organization of the Common Technical 

Document for the Registration of 

Pharmaceuticals for Human Use.’’ The 

guidance was prepared under the 

auspices of the International Council for 

Harmonisation (ICH), formerly the 

International Conference on 

Harmonisation. The guidance updates 

the Quality-related sections of the 

Granularity Document Annex, Module 

2.3 Quality Overall Summary, and 

Module 3 Quality. The guidance is 

intended to provide recommendations 

on the organization of the common 

technical document (CTD)/eCTD and 

replaces the August 2001 FDA guidance 

for industry ‘‘M4: Organization of the 

CTD’’ and the October 2005 FDA 

guidance for industry ‘‘Granularity 

Document Annex to M4: Organization of 

the CTD.’’ 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 3, 2017. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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–5139 for ‘‘M4 Organization of 

the Common Technical Document for 

the Registration of Pharmaceuticals for 

Human Use; 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 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 


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Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46079 

‘‘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 (CDER), 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: Norman R. 

Schmuff, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 21, Rm. 2526, Silver Spring, 

MD 20993–0002, Norman.Schmuff@

fda.hhs.gov; or Stephen Ripley, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 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, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically-based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized 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; the Japanese Ministry of 

Health, Labour, and Welfare; the 

Japanese Pharmaceutical Manufacturers 

Association; CDER and CBER, FDA; 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 M4 guidance provides guidance 

on the organization of the CTD and 

eCTD for Modules 2 through 5 

providing direction on the location and 

hierarchy of headings within modules, 

document pagination and segregation, 

section numbering within documents, 

and the formatting of the table of 

contents. The guidance updates the 

Quality-related sections of the 

Granularity Document Annex, Module 

2.3 Quality Overall Summary, and 

Module 3 Quality. The guidance 

provides separate tables describing the 

recommended granularity for paper and 

eCTD v3.2.2 submissions, and for paper 

and eCTD v4 submissions, and includes 

‘‘Appendices for eCTD v4 Submissions’’ 

to facilitate the implementation of the 

next major version of the eCTD. This 

guidance replaces both the August 2001 

FDA GIF ‘‘M4: Organization of the CTD’’ 

and the October 2005 FDA GIF 

‘‘Granularity Document Annex to M4: 

Organization of the CTD.’’ This merger 

reflects the 2002 addition of the Annex: 

Granularity Document into the ‘‘M4 

Organization of the Common Technical 

Document for the Registration of 

Pharmaceuticals for Human Use.’’ 

There have been no updates or 

changes relative to Module 4 or Module 

5. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on the organization of 

the CTD for the registration of 

pharmaceuticals for human use. 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. 

II. Electronic Access 

Persons with access to the internet 

may obtain the document at https://

www.regulations.gov, https://

www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, or https://www.fda.gov/ 

BiologicsBloodVaccines/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm. 

Dated: September 28, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–21229 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4563] 

Johnson & Johnson Consumer Inc. et 

al.; Withdrawal of Approval of 7 New 

Drug Applications and 71 Abbreviated 

New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of 7 new drug applications 

(NDAs) and 71 abbreviated new drug 

applications (ANDAs) from multiple 


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