82 FR 46078 - M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use; International Council for Harmonisation; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 190 (October 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 190 (October 3, 2017)
| Page Range | 46078-46079 | |
| FR Document | 2017-21229 |
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)] [Notices] [Pages 46078-46079] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21229] ----------------------------------------------------------------------- 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 [[Page 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.thefederalregister.org/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, [email protected]; 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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/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
![46078 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
the docket (see the ADDRESSES section) DEPARTMENT OF HEALTH AND that if you include your name, contact
on or before October 17, 2017, will be HUMAN SERVICES information, or other information that
provided to the committees. Oral identifies you in the body of your
presentations from the public will be Food and Drug Administration comments, that information will be
scheduled between approximately 1 [Docket No. FDA–2017–D–5139] posted on https://www.regulations.gov.
p.m. and 2 p.m. Those individuals • If you want to submit a comment
interested in making formal oral M4 Organization of the Common with confidential information that you
presentations should notify the contact Technical Document for the do not wish to be made available to the
Registration of Pharmaceuticals for public, submit the comment as a
person and submit a brief statement of
Human Use; International Council for written/paper submission and in the
the general nature of the evidence or
Harmonisation; Guidance for Industry; manner detailed (see ‘‘Written/Paper
arguments they wish to present, the Submissions’’ and ‘‘Instructions’’).
names and addresses of proposed Availability
participants, and an indication of the AGENCY: Food and Drug Administration, Written/Paper Submissions
approximate time requested to make HHS. Submit written/paper submissions as
their presentation on or before October ACTION: Notice of availability. follows:
6, 2017. Time allotted for each • Mail/Hand delivery/Courier (for
presentation may be limited. If the SUMMARY: The Food and Drug written/paper submissions): Dockets
number of registrants requesting to Administration (FDA or Agency) is Management Staff (HFA–305), Food and
speak is greater than can be reasonably announcing the availability of a Drug Administration, 5630 Fishers
guidance for industry (GIF) entitled ‘‘M4 Lane, Rm. 1061, Rockville, MD 20852.
accommodated during the scheduled
open public hearing session, FDA may
Organization of the Common Technical • For written/paper comments
Document for the Registration of submitted to the Dockets Management
conduct a lottery to determine the Pharmaceuticals for Human Use.’’ The Staff, FDA will post your comment, as
speakers for the scheduled open public guidance was prepared under the well as any attachments, except for
hearing session. The contact person will auspices of the International Council for information submitted, marked and
notify interested persons regarding their Harmonisation (ICH), formerly the identified, as confidential, if submitted
request to speak by October 10, 2017. International Conference on as detailed in ‘‘Instructions.’’
Persons attending FDA’s advisory Harmonisation. The guidance updates Instructions: All submissions received
committee meetings are advised that the the Quality-related sections of the must include the Docket No. FDA–
Agency is not responsible for providing Granularity Document Annex, Module 2017–D–5139 for ‘‘M4 Organization of
access to electrical outlets. 2.3 Quality Overall Summary, and the Common Technical Document for
Module 3 Quality. The guidance is the Registration of Pharmaceuticals for
FDA welcomes the attendance of the
intended to provide recommendations Human Use; International Council for
public at its advisory committee on the organization of the common Harmonisation; Guidance for Industry;
meetings and will make every effort to technical document (CTD)/eCTD and Availability.’’ Received comments will
accommodate persons with disabilities. replaces the August 2001 FDA guidance be placed in the docket and, except for
If you require special accommodations for industry ‘‘M4: Organization of the those submitted as ‘‘Confidential
due to a disability, please contact CTD’’ and the October 2005 FDA Submissions,’’ publicly viewable at
Kalyani Bhatt at least 7 days in advance guidance for industry ‘‘Granularity https://www.regulations.gov or at the
of the meeting. Document Annex to M4: Organization of Dockets Management Staff between 9
FDA is committed to the orderly the CTD.’’ a.m. and 4 p.m., Monday through
conduct of its advisory committee DATES: The announcement of the Friday.
meetings. Please visit our Web site at guidance is published in the Federal • Confidential Submissions—To
https://www.fda.gov/Advisory Register on October 3, 2017. submit a comment with confidential
Committees/AboutAdvisoryCommittees/ ADDRESSES: You may submit either information that you do not wish to be
ucm111462.htm for procedures on electronic or written comments on made publicly available, submit your
public conduct during advisory Agency guidances at any time as comments only as a written/paper
follows: submission. You should submit two
committee meetings.
copies total. One copy will include the
Notice of this meeting is given under Electronic Submissions information you claim to be confidential
the Federal Advisory Committee Act (5 Submit electronic comments in the with a heading or cover note that states
U.S.C. app. 2). following way: ‘‘THIS DOCUMENT CONTAINS
Dated: September 27, 2017. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Anna K. Abram,
https://www.regulations.gov. Follow the Agency will review this copy, including
instructions for submitting comments. the claimed confidential information, in
Deputy Commissioner for Policy, Planning,
Comments submitted electronically, its consideration of comments. The
Legislation, and Analysis.
including attachments, to https:// second copy, which will have the
[FR Doc. 2017–21171 Filed 10–2–17; 8:45 am]
www.regulations.gov will be posted to claimed confidential information
BILLING CODE 4164–01–P the docket unchanged. Because your redacted/blacked out, will be available
asabaliauskas on DSKBBXCHB2PROD with NOTICES
comment will be made public, you are for public viewing and posted on
solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
third party may not wish to be posted, contact information to be made publicly
such as medical information, your or available, you can provide this
anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
as a manufacturing process. Please note 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 I. Background and eCTD v4 submissions, and includes
as ‘‘confidential’’ will not be disclosed In recent years, many important ‘‘Appendices for eCTD v4 Submissions’’
except in accordance with 21 CFR 10.20 initiatives have been undertaken by to facilitate the implementation of the
and other applicable disclosure law. For regulatory authorities and industry next major version of the eCTD. This
more information about FDA’s posting associations to promote international guidance replaces both the August 2001
of comments to public dockets, see 80 harmonization of regulatory FDA GIF ‘‘M4: Organization of the CTD’’
FR 56469, September 18, 2015, or access requirements. FDA has participated in and the October 2005 FDA GIF
the information at: https://www.gpo.gov/ many meetings designed to enhance ‘‘Granularity Document Annex to M4:
fdsys/pkg/FR-2015-09-18/pdf/2015- harmonization and is committed to Organization of the CTD.’’ This merger
23389.pdf. seeking scientifically-based harmonized reflects the 2002 addition of the Annex:
Docket: For access to the docket to Granularity Document into the ‘‘M4
technical procedures for pharmaceutical
read background documents or the Organization of the Common Technical
development. One of the goals of
electronic and written/paper comments Document for the Registration of
harmonization is to identify and then
received, go to https:// Pharmaceuticals for Human Use.’’
reduce differences in technical There have been no updates or
www.regulations.gov and insert the requirements for drug development changes relative to Module 4 or Module
docket number, found in brackets in the among regulatory agencies. 5.
heading of this document, into the ICH was organized to provide an This guidance is being issued
‘‘Search’’ box and follow the prompts opportunity for harmonization consistent with FDA’s good guidance
and/or go to the Dockets Management initiatives to be developed with input practices regulation (21 CFR 10.115).
Staff, 5630 Fishers Lane, Rm. 1061, from both regulatory and industry The guidance represents the current
Rockville, MD 20852. representatives. FDA also seeks input thinking of FDA on the organization of
You may submit comments on any from consumer representatives and the CTD for the registration of
guidance at any time (see 21 CFR others. ICH is concerned with pharmaceuticals for human use. It does
10.115(g)(5)). harmonization of technical not establish any rights for any person
requirements for the registration of and is not binding on FDA or the public.
Submit written requests for single
pharmaceutical products for human use You can use an alternative approach if
copies of this guidance to the Division
among regulators around the world. The it satisfies the requirements of the
of Drug Information, Center for Drug
six founding members of the ICH are the applicable statutes and regulations.
Evaluation and Research, Food and
European Commission; the European
Drug Administration (CDER), 10001 II. Electronic Access
Federation of Pharmaceutical Industries
New Hampshire Ave., Hillandale
Associations; the Japanese Ministry of Persons with access to the internet
Building, 4th Floor, Silver Spring, MD
Health, Labour, and Welfare; the may obtain the document at https://
20993–0002, or the Office of
Japanese Pharmaceutical Manufacturers www.regulations.gov, https://
Communication, Outreach and
Association; CDER and CBER, FDA; and www.fda.gov/Drugs/
Development, Center for Biologics
the Pharmaceutical Research and GuidanceCompliance
Evaluation and Research (CBER), Food
Manufacturers of America. The RegulatoryInformation/Guidances/
and Drug Administration, 10903 New
Standing Members of the ICH default.htm, or https://www.fda.gov/
Hampshire Ave., Bldg. 71, Rm. 3128,
Association include Health Canada and BiologicsBloodVaccines/
Silver Spring, MD 20993–0002. Send
Swissmedic. Any party eligible as a GuidanceCompliance
one self-addressed adhesive label to
member in accordance with the ICH RegulatoryInformation/Guidances/
assist that office in processing your
Articles of Association can apply for default.htm.
requests. The guidance may also be
membership in writing to the ICH
obtained by mail by calling CBER at 1– Dated: September 28, 2017.
Secretariat. The ICH Secretariat, which
800–835–4709 or 240–402–8010. See Leslie Kux,
coordinates the preparation of
the SUPPLEMENTARY INFORMATION section Associate Commissioner for Policy.
documentation, operates as an
for electronic access to the guidance [FR Doc. 2017–21229 Filed 10–2–17; 8:45 am]
international nonprofit organization and
document.
is funded by the members of the ICH BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT: Association.
The ICH Assembly is the overarching
Regarding the guidance: Norman R. DEPARTMENT OF HEALTH AND
body of the Association and includes
Schmuff, Center for Drug Evaluation HUMAN SERVICES
representatives from each of the ICH
and Research, Food and Drug
members and observers.
Administration, 10903 New Hampshire Food and Drug Administration
The M4 guidance provides guidance
Ave., Bldg. 21, Rm. 2526, Silver Spring,
on the organization of the CTD and [Docket No. FDA–2017–N–4563]
MD 20993–0002, Norman.Schmuff@
eCTD for Modules 2 through 5
fda.hhs.gov; or Stephen Ripley, Center Johnson & Johnson Consumer Inc. et
providing direction on the location and
for Biologics Evaluation and Research, al.; Withdrawal of Approval of 7 New
hierarchy of headings within modules,
Food and Drug Administration, 10903 Drug Applications and 71 Abbreviated
document pagination and segregation,
New Hampshire Ave., Bldg. 71, Rm. New Drug Applications
section numbering within documents,
7301, Silver Spring, MD 20993–0002,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
and the formatting of the table of AGENCY: Food and Drug Administration,
240–402–7911. Regarding the ICH:
contents. The guidance updates the HHS.
Amanda Roache, Center for Drug
Quality-related sections of the ACTION: Notice.
Evaluation and Research, Food and
Granularity Document Annex, Module
Drug Administration, 10903 New
2.3 Quality Overall Summary, and SUMMARY: The Food and Drug
Hampshire Ave., Bldg. 51, Rm. 1176,
Module 3 Quality. The guidance Administration (FDA) is withdrawing
Silver Spring, MD 20993–0002, 301–
provides separate tables describing the approval of 7 new drug applications
796–4548.
recommended granularity for paper and (NDAs) and 71 abbreviated new drug
SUPPLEMENTARY INFORMATION: eCTD v3.2.2 submissions, and for paper applications (ANDAs) from multiple
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Document Created: 2017-10-03 01:01:23
Document Modified: 2017-10-03 01:01:23
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on October 3, 2017. | |
| 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, [email protected]; 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. | |
| FR Citation | 82 FR 46078 |
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