80 FR 23279 - M8 Electronic Common Technical Document v4.0 Draft Implementation Guide v2.0; Electronic Common Technical Document v4.0 Implementation Package Draft Specification for Submission Formats v2.0; International Conference on Harmonisation; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 80 (April 27, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 80 (April 27, 2015)
| Page Range | 23279-23280 | |
| FR Document | 2015-09646 |
[Federal Register Volume 80, Number 80 (Monday, April 27, 2015)] [Notices] [Pages 23279-23280] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09646] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-1309] M8 Electronic Common Technical Document v4.0 Draft Implementation Guide v2.0; Electronic Common Technical Document v4.0 Implementation Package Draft Specification for Submission Formats v2.0; International Conference on Harmonisation; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``M8 Electronic Common Technical Document (eCTD) v4.0 Draft Implementation Guide v2.0'' (the M8 eCTD draft implementation guidance) and a related document entitled ``eCTD v4.0 Implementation Package Draft Specification for Submission Formats v2.0'' (the draft specifications document). The M8 eCTD draft implementation guidance and the draft specifications document were prepared under the auspices of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. The M8 eCTD draft implementation guidance provides instructions for creating the eCTD v4.0 Health Level 7 Regulated Product Submission (RPS) message for Modules 2 through 5 of the eCTD. The draft specifications document provides specifications for creating files for inclusion in the eCTD. These draft documents represent major updates to the eCTD specifications. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the Agency considers your comment on these draft documents before it begins work on the final versions of the documents, submit either electronic or written comments on the draft documents by May 27, 2015. ADDRESSES: Submit written requests for single copies of the draft documents to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research (CDER), 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 the office in processing your requests. The draft documents may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402- 7800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance documents. Submit electronic comments on the draft documents to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Jared Lantzy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1116, Silver Spring, MD 20993- 0002, 301-796-0597; or Mark Gray, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7217, Silver Spring, MD 20993-0002, 301-796-2081. Regarding the ICH: Michelle Limoli, Center for Drug Evaluation and Research, International Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1174, Silver Spring, MD 20993-0002, 301-796-8377. 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 tripartite harmonization initiatives to be developed with input [[Page 23280]] 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 among three regions: The European Union, Japan, and the United States. The eight ICH sponsors 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; the Pharmaceutical Research and Manufacturers of America; Health Canada; and Swissmedic. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization and the European Free Trade Area. The eCTD is an ICH standard based on specifications developed by ICH and its member parties. The ICH M2 Expert Working Group has previously developed a list of requirements for input in the eCTD RPS Project. The list of requirements was last updated on November 11, 2010, and is available at http://estri.ich.org/ICH_eCTD_NMV_Requirements-V4-0.pdf (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register). The ICH M8 Expert Working Group was formed in November 2010 to assume responsibility for the continued development of the next major version of the eCTD. In February 2015, the ICH Steering Committee agreed that a draft guidance entitled ``M8 eCTD v4.0 Draft Implementation Guide v2.0'' and the related document entitled ``eCTD v4.0 Implementation Package Draft Specification for Submission Formats v2.0'' should be made available for public comment. These documents are the product of the M8 Expert Working Group. Comments about these draft documents will be considered by FDA and the M8 Expert Working Group. Since adoption of the eCTD standard, the ICH Steering Committee has endorsed using the RPS Release 2 standard. A core feature of the RPS standard is the flexibility the message provides to enable future eCTD enhancements. The M8 eCTD draft implementation guidance provides instructions for creating the eCTD v4.0 RPS message for the ICH Modules 2 through 5 of the eCTD. The draft specifications document provides specifications for creating files for inclusion in the eCTD. These draft documents facilitate implementation of the eCTD v4.0 standard. The draft documents are being issued as a package that includes the draft ICH code list and the M8 schema files. In addition, the FDA regional/module 1 documents have been developed and are available at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm309911.htm. The M8 eCTD draft implementation 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 this topic. 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. Comments Interested persons may submit either electronic comments regarding these documents to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the documents at http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Dated: April 21, 2015. Peter Lurie, Associate Commissioner for Public Health Strategy and Analysis. [FR Doc. 2015-09646 Filed 4-24-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 80 / Monday, April 27, 2015 / Notices 23279
represented on the APOE. Therefore, we Dated: April 21, 2015. the Division of Drug Information (HFD–
encourage nominations of qualified Andrew M. Slavitt 240), Center for Drug Evaluation and
candidates who can represent these Acting Administrator, Centers for Medicare Research (CDER), Food and Drug
interests. Any interested organization or & Medicaid Services. Administration, 10001 New Hampshire
person may nominate one or more [FR Doc. 2015–09730 Filed 4–24–15; 8:45 am] Ave., Hillandale Building, 4th Floor,
qualified persons. BILLING CODE 4120–01–P Silver Spring, MD 20993–0002; or the
Each nomination must include a letter Office of Communication, Outreach and
stating that the nominee has expressed Development, Center for Biologics
a willingness to serve as a Panel DEPARTMENT OF HEALTH AND Evaluation and Research (CBER), Food
member and must be accompanied by a HUMAN SERVICES and Drug Administration, 10903 New
curricula vitae and a brief biographical Hampshire Ave., Bldg. 71, rm. 3128,
summary of the nominee’s experience. Food and Drug Administration Silver Spring, MD 20993–0002. Send
[Docket No. FDA–2015–D–1309] one self-addressed adhesive label to
While we are looking for experts in a
assist the office in processing your
number of fields, our most critical needs
M8 Electronic Common Technical requests. The draft documents may also
are for experts in Health IT, Tribal
Document v4.0 Draft Implementation be obtained by mail by calling CBER at
Affairs, Community Health Centers/
Guide v2.0; Electronic Common 1–800–835–4709 or 240–402–7800. See
Medically Underserved Populations,
Technical Document v4.0 the SUPPLEMENTARY INFORMATION section
African-American Health/Disparities,
Implementation Package Draft for electronic access to the draft
Health/Disability, Quality/Disparities,
Specification for Submission Formats guidance documents.
and State Programs/Medicaid/Rural.
v2.0; International Conference on Submit electronic comments on the
We are requesting that all curricula Harmonisation; Draft Guidance for draft documents to http://
vitae include the following: Industry; Availability www.regulations.gov. Submit written
• Date of birth comments to the Division of Dockets
AGENCY: Food and Drug Administration, Management (HFA–305), Food and Drug
• Place of birth HHS. Administration, 5630 Fishers Lane, rm.
• Title and current position ACTION: Notice. 1061, Rockville, MD 20852.
• Professional affiliation FOR FURTHER INFORMATION CONTACT:
• Home and business address SUMMARY: The Food and Drug
Administration (FDA or Agency) is Regarding the guidance: Jared Lantzy,
• Telephone and fax numbers announcing the availability of a draft Center for Drug Evaluation and
• Email address guidance entitled ‘‘M8 Electronic Research, Food and Drug
Administration, 10903 New Hampshire
• List of areas of expertise Common Technical Document (eCTD)
Ave., Bldg. 22, Rm. 1116, Silver Spring,
v4.0 Draft Implementation Guide v2.0’’
Phone interviews of nominees may also (the M8 eCTD draft implementation MD 20993–0002, 301–796–0597; or
be requested after review of the guidance) and a related document Mark Gray, Center for Biologics
nominations. entitled ‘‘eCTD v4.0 Implementation Evaluation and Research, Food and
Package Draft Specification for Drug Administration, 10903 New
In order to permit an evaluation of Hampshire Ave., Bldg. 71, Rm. 7217,
possible sources of conflict of interest, Submission Formats v2.0’’ (the draft
specifications document). The M8 eCTD Silver Spring, MD 20993–0002, 301–
potential candidates will be asked to 796–2081.
provide detailed information concerning draft implementation guidance and the
Regarding the ICH: Michelle Limoli,
such matters as financial holdings, draft specifications document were
Center for Drug Evaluation and
consultancies, and research grants or prepared under the auspices of the
Research, International Programs, Food
contracts. International Conference on
and Drug Administration, 10903 New
Harmonisation (ICH) of Technical
Members are invited to serve for 2- Hampshire Ave., Bldg. 51, Rm. 1174,
Requirements for Registration of
year terms, contingent upon the renewal Silver Spring, MD 20993–0002, 301–
Pharmaceuticals for Human Use. The
of the APOE by appropriate action prior 796–8377.
M8 eCTD draft implementation
to its termination. A member may serve SUPPLEMENTARY INFORMATION:
guidance provides instructions for
after the expiration of his or her term
creating the eCTD v4.0 Health Level 7 I. Background
until a successor takes office. Any
Regulated Product Submission (RPS)
member appointed to fill a vacancy for In recent years, many important
message for Modules 2 through 5 of the
an unexpired term shall be appointed initiatives have been undertaken by
eCTD. The draft specifications
for the remainder of that term. regulatory authorities and industry
document provides specifications for
III. Copies of the Charter creating files for inclusion in the eCTD. associations to promote international
These draft documents represent major harmonization of regulatory
The Secretary’s Charter for the APOE updates to the eCTD specifications. requirements. FDA has participated in
is available on the CMS Web site at: many meetings designed to enhance
DATES: Although you can comment on
http://www.cms.gov/Regulations- harmonization and is committed to
andGuidance/Guidance/FACA/ any guidance at any time (see 21 CFR seeking scientifically based harmonized
APOE.html, or you may obtain a copy of 10.115 (g)(5)), to ensure that the Agency technical procedures for pharmaceutical
the charter by submitting a request to considers your comment on these draft development. One of the goals of
Rmajette on DSK2VPTVN1PROD with NOTICES
the contact listed in the FOR FURTHER documents before it begins work on the harmonization is to identify and then
INFORMATION CONTACT section of this
final versions of the documents, submit reduce differences in technical
notice. either electronic or written comments requirements for drug development
on the draft documents by May 27, among regulatory agencies.
Authority: Sec. 222 of the Public Health 2015.
Service Act (42 U.S.C. 217a) and sec. 10(a) ICH was organized to provide an
of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a) ADDRESSES: Submit written requests for opportunity for tripartite harmonization
and 41 CFR 102–3). single copies of the draft documents to initiatives to be developed with input
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![23280 Federal Register / Vol. 80, No. 80 / Monday, April 27, 2015 / Notices
from both regulatory and industry enhancements. The M8 eCTD draft DEPARTMENT OF HEALTH AND
representatives. FDA also seeks input implementation guidance provides HUMAN SERVICES
from consumer representatives and instructions for creating the eCTD v4.0
others. ICH is concerned with RPS message for the ICH Modules 2 National Institutes of Health
harmonization of technical through 5 of the eCTD. The draft
requirements for the registration of specifications document provides Center For Scientific Review; Notice of
pharmaceutical products among three Closed Meetings
specifications for creating files for
regions: The European Union, Japan, inclusion in the eCTD. These draft Pursuant to section 10(d) of the
and the United States. The eight ICH documents facilitate implementation of Federal Advisory Committee Act, as
sponsors are the European Commission; the eCTD v4.0 standard. The draft amended (5 U.S.C. App.), notice is
the European Federation of documents are being issued as a package hereby given of the following meetings.
Pharmaceutical Industries Associations; that includes the draft ICH code list and The meetings will be closed to the
the Japanese Ministry of Health, Labour, public in accordance with the
the M8 schema files. In addition, the
and Welfare; the Japanese provisions set forth in sections
FDA regional/module 1 documents have
Pharmaceutical Manufacturers 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Association; CDER and CBER, FDA; the been developed and are available at
http://www.fda.gov/Drugs/ as amended. The grant applications and
Pharmaceutical Research and the discussions could disclose
Manufacturers of America; Health DevelopmentApprovalProcess/
FormsSubmissionRequirements/ confidential trade secrets or commercial
Canada; and Swissmedic. The ICH property such as patentable material,
Secretariat, which coordinates the ElectronicSubmissions/ucm309911.htm.
and personal information concerning
preparation of documentation, is The M8 eCTD draft implementation individuals associated with the grant
provided by the International guidance is being issued consistent with applications, the disclosure of which
Federation of Pharmaceutical FDA’s good guidance practices would constitute a clearly unwarranted
Manufacturers Associations (IFPMA). regulation (21 CFR 10.115). The draft invasion of personal privacy.
The ICH Steering Committee includes guidance, when finalized, will represent
representatives from each of the ICH Name of Committee: Cell Biology
the current thinking of FDA on this Integrated Review Group; Nuclear and
sponsors and the IFPMA, as well as topic. It does not establish any rights for
observers from the World Health Cytoplasmic Structure/Function and
any person and is not binding on FDA Dynamics Study Section.
Organization and the European Free or the public. You can use an alternative Date: May 28–29, 2015.
Trade Area. Time: 8:00 a.m. to 5:00 p.m.
The eCTD is an ICH standard based approach if it satisfies the requirements
of the applicable statutes and Agenda: To review and evaluate grant
on specifications developed by ICH and applications.
its member parties. The ICH M2 Expert regulations.
Place: BW Plus Tuscan, a Kimpton Hotel,
Working Group has previously II. Comments 425 North Point Street, San Francisco, CA
developed a list of requirements for 94133.
input in the eCTD RPS Project. The list Interested persons may submit either Contact Person: David Balasundaram,
of requirements was last updated on electronic comments regarding these Ph.D., Scientific Review Officer, Center for
November 11, 2010, and is available at documents to http:// Scientific Review, National Institutes of
http://estri.ich.org/ICH_eCTD_NMV_ Health, 6701 Rockledge Drive, Room 5189,
www.regulations.gov or written MSC 7840, Bethesda, MD 20892, 301–435–
Requirements-V4-0.pdf (FDA has comments to the Division of Dockets 1022, balasundaramd@csr.nih.gov.
verified the Web site address, but FDA Management (see ADDRESSES). It is Name of Committee: Population Sciences
is not responsible for any subsequent only necessary to send one set of and Epidemiology Integrated Review Group;
changes to the Web site after this comments. Identify comments with the Kidney, Nutrition, Obesity and Diabetes
document publishes in the Federal docket number found in brackets in the Study Section.
Register). heading of this document. Received Date: May 28–29, 2015.
The ICH M8 Expert Working Group comments may be seen in the Division Time: 8:00 a.m. to 3:30 p.m.
was formed in November 2010 to of Dockets Management between 9 a.m. Agenda: To review and evaluate grant
assume responsibility for the continued and 4 p.m., Monday through Friday, and applications.
development of the next major version Place: Hotel Nikko San Francisco, 222
will be posted to the docket at http:// Mason Street, San Francisco, CA 94102.
of the eCTD. www.regulations.gov.
In February 2015, the ICH Steering Contact Person: Fungai Chanetsa, Ph.D.,
Committee agreed that a draft guidance MPH, Scientific Review Officer, Center for
III. Electronic Access Scientific Review, National Institutes of
entitled ‘‘M8 eCTD v4.0 Draft Health, 6701 Rockledge Drive, Room 3135,
Implementation Guide v2.0’’ and the Persons with access to the Internet
MSC 7770, Bethesda, MD 20892, 301–408–
related document entitled ‘‘eCTD v4.0 may obtain the documents at http:// 9436, fungai.chanetsa@nih.hhs.gov.
Implementation Package Draft www.regulations.gov, http://
Name of Committee: Center for Scientific
Specification for Submission Formats www.fda.gov/Drugs/Guidance Review Special Emphasis Panel; PAR Panel:
v2.0’’ should be made available for ComplianceRegulatoryInformation/ High Throughput Screening.
public comment. These documents are Guidances/default.htm, or http:// Date: May 28, 2015.
the product of the M8 Expert Working www.fda.gov/BiologicsBloodVaccines/ Time: 8:00 a.m. to 6:00 p.m.
Group. Comments about these draft GuidanceComplianceRegulatory Agenda: To review and evaluate grant
documents will be considered by FDA Information/Guidances/default.htm. applications.
Rmajette on DSK2VPTVN1PROD with NOTICES
and the M8 Expert Working Group. Place: Residence Inn Bethesda, 7335
Dated: April 21, 2015. Wisconsin Avenue, Bethesda, MD 20814.
Since adoption of the eCTD standard,
Peter Lurie, Contact Person: Nancy Templeton, Ph.D.,
the ICH Steering Committee has Scientific Review Officer, Center for
endorsed using the RPS Release 2 Associate Commissioner for Public Health
Scientific Review, National Institutes of
standard. A core feature of the RPS Strategy and Analysis.
Health, 6701 Rockledge Drive, Room 5168,
standard is the flexibility the message [FR Doc. 2015–09646 Filed 4–24–15; 8:45 am] MSC 7849, Bethesda, MD 20892, 301–408–
provides to enable future eCTD BILLING CODE 4164–01–P 9694, templetonns@mail.nih.gov.
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Document Created: 2015-12-16 08:29:42
Document Modified: 2015-12-16 08:29:42
| 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. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the Agency considers your comment on these draft documents before it begins work on the final versions of the documents, submit either electronic or written comments on the draft documents by May 27, 2015. | |
| Contact | Regarding the guidance: Jared Lantzy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1116, Silver Spring, MD 20993- 0002, 301-796-0597; or Mark Gray, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7217, Silver Spring, MD 20993-0002, 301-796-2081. | |
| FR Citation | 80 FR 23279 |
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