80 FR 60389 - Electronic Common Technical Document Technical Conformance Guide; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 193 (October 6, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 193 (October 6, 2015)
| Page Range | 60389-60390 | |
| FR Document | 2015-25353 |
[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)] [Notices] [Pages 60389-60390] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25353] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-3390] Electronic Common Technical Document Technical Conformance Guide; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of an Electronic Common Technical Document (eCTD) Technical Conformance Guide, Version 1.0. The eCTD Technical Conformance Guide supplements the guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specification'' and provides specifications, recommendations, and general considerations on how to submit eCTD-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). DATES: Although you can comment on this notice at any time, to ensure that the Agency considers your comments, submit either electronic or written comments by November 20, 2015. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2015-D-3390 for ``Electronic Common Technical Document Technical Conformance Guide.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the documents to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002 or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-0002, ronald.fitzmartin@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. [[Page 60390]] 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of an eCTD Technical Conformance Guide, Version 1.0. The eCTD Technical Conformance Guide supplements the final guidance for industry ``Providing Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specification'' (eCTD Guidance) and provides specifications, recommendations, and general considerations on how to submit eCTD-based electronic submission to CDER or CBER. The eCTD guidance will implement the electronic submission requirements of section 745A(a) of the Food, Drug & Cosmetic Act with respect to electronic submissions for certain investigational new drug applications (INDs); new drug applications (NDAs); abbreviated new drug applications(ANDAs); certain biologics license applications(BLAs); and Master Files that are submitted to the CDER or CBER. The Guide provides specifications, recommendations, and general considerations on how to submit eCTD-based electronic submissions to CDER or CBER and is intended to complement and promote interactions between sponsors and applicants and FDA's review divisions. It is not intended to replace the need for sponsors and applicants to communicate directly with review divisions regarding their eCTD-based submissions. The Guide is organized as follows: Section 1: Introduction--provides information on regulatory policy and guidance background, purpose, and document control. Section 2: General Considerations--recommends and provides general details on preparing an eCTD submission. Section 3: Organization of the eCTD--presents specific topics organized by their placement (by module) in the eCTD submission. Section 4: Issues and Solutions--presents instructions for correcting common problems seen in eCTD submissions. II. Electronic Access Persons with access to the Internet may obtain the Guide at either http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm or http://www.regulations.gov. Dated: September 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-25353 Filed 10-5-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices 60389
labeling, provided that OGD is able to ADDRESSES: You may submit comments copies total. One copy will include the
make a determination that the draft as follows: information you claim to be confidential
labeling complies with applicable with a heading or cover note that states
Electronic Submissions
requirements (other than editorial or ‘‘THIS DOCUMENT CONTAINS
similar minor deficiencies). Submit electronic comments in the CONFIDENTIAL INFORMATION’’. The
The guidance represents the Agency’s following way: Agency will review this copy, including
current thinking on the acceptability of • Federal eRulemaking Portal: http:// the claimed confidential information, in
draft labeling to support ANDA www.regulations.gov. Follow the its consideration of comments. The
approval. It does not establish any rights instructions for submitting comments. second copy, which will have the
for any person and is not binding on Comments submitted electronically, claimed confidential information
FDA or the public. You can use an including attachments, to http:// redacted/blacked out, will be available
alternative approach if it satisfies the www.regulations.gov will be posted to for public viewing and posted on
requirements of the applicable statutes the docket unchanged. Because your http://www.regulations.gov. Submit
and regulations. comment will be made public, you are both copies to the Division of Dockets
solely responsible for ensuring that your Management. If you do not wish your
II. Electronic Access comment does not include any name and contact information to be
Persons with access to the Internet confidential information that you or a made publicly available, you can
may obtain the document at either third party may not wish to be posted, provide this information on the cover
http://www.fda.gov/Drugs/Guidance such as medical information, your or sheet and not in the body of your
ComplianceRegulatoryInformation/ anyone else’s Social Security number, or comments and you must identify this
Guidances/default.htm or http:// confidential business information, such information as ‘‘confidential.’’ Any
www.regulations.gov. as a manufacturing process. Please note information marked as ‘‘confidential’’
that if you include your name, contact will not be disclosed except in
Dated: September 30, 2015.
information, or other information that accordance with 21 CFR 10.20 and other
Leslie Kux, identifies you in the body of your applicable disclosure law. For more
Associate Commissioner for Policy. comments, that information will be information about FDA’s posting of
[FR Doc. 2015–25351 Filed 10–5–15; 8:45 am] posted on http://www.regulations.gov. comments to public dockets, see 80 FR
BILLING CODE 4164–01–P • If you want to submit a comment 56469, September 18, 2015, or access
with confidential information that you the information at: http://www.fda.gov/
do not wish to be made available to the regulatoryinformation/dockets/
DEPARTMENT OF HEALTH AND public, submit the comment as a default.htm.
HUMAN SERVICES written/paper submission and in the
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Food and Drug Administration Submissions’’ and ‘‘Instructions’’). read background documents or the
electronic and written/paper comments
[Docket No. FDA–2015–D–3390] Written/Paper Submissions received, go to http://
Submit written/paper submissions as www.regulations.gov and insert the
Electronic Common Technical follows: docket number, found in brackets in the
Document Technical Conformance • Mail/Hand delivery/Courier (for heading of this document, into the
Guide; Availability written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
Dockets Management (HFA–305), Food and/or go to the Division of Dockets
AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
HHS. Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
ACTION: Notice. • For written/paper comments Submit written requests for single
submitted to the Division of Dockets copies of the documents to the Division
SUMMARY: The Food and Drug Management, FDA will post your
Administration (FDA) is announcing the of Drug Information, Center for Drug
comment, as well as any attachments, Evaluation and Research, Food and
availability of an Electronic Common except for information submitted,
Technical Document (eCTD) Technical Drug Administration, 10903 New
marked and identified, as confidential, Hampshire Ave., Bldg. 51, Rm. 2201,
Conformance Guide, Version 1.0. The if submitted as detailed in
eCTD Technical Conformance Guide Silver Spring, MD 20993–0002 or the
‘‘Instructions.’’ Office of Communication, Outreach and
supplements the guidance for industry Instructions: All submissions received
entitled ‘‘Providing Regulatory Development, Center for Biologics
must include the Docket No. FDA– Evaluation and Research, Food and
Submissions in Electronic Format— 2015–D–3390 for ‘‘Electronic Common
Certain Human Pharmaceutical Product Drug Administration, 10903 New
Technical Document Technical Hampshire Avenue, Bldg. 71, Rm. 3128,
Applications and Related Submissions Conformance Guide.’’ Received
Using the eCTD Specification’’ and Silver Spring, MD 20993–0002. Send
comments will be placed in the docket one self-addressed adhesive label to
provides specifications, and, except for those submitted as
recommendations, and general assist that office in processing your
‘‘Confidential Submissions,’’ publicly requests.
considerations on how to submit eCTD- viewable at http://www.regulations.gov
based electronic submissions to the or at the Division of Dockets FOR FURTHER INFORMATION CONTACT: Ron
Center for Drug Evaluation and Research Management between 9 a.m. and 4 p.m., Fitzmartin, Center for Drug Evaluation
(CDER) or the Center for Biologics
tkelley on DSK3SPTVN1PROD with NOTICES
Monday through Friday. and Research, Food and Drug
Evaluation and Research (CBER). • Confidential Submissions—To Administration, 10903 New Hampshire
DATES: Although you can comment on submit a comment with confidential Ave., Bldg. 51, Rm. 1192, Silver Spring,
this notice at any time, to ensure that information that you do not wish to be MD 20993–0002, ronald.fitzmartin@
the Agency considers your comments, made publicly available, submit your fda.hhs.gov; or Stephen Ripley, Center
submit either electronic or written comments only as a written/paper for Biologics Evaluation and Research,
comments by November 20, 2015. submission. You should submit two Food and Drug Administration, Bldg.
VerDate Sep<11>2014 18:31 Oct 05, 2015 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\06OCN1.SGM 06OCN1](https://thefederalregister.org/doc/80_FR_60582/page/1.svg)
![60390 Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices
71, Rm. 7301, Silver Spring, MD 20993– Dated: September 30, 2015. public, submit the comment as a
0002, 240–402–7911. Leslie Kux, written/paper submission and in the
SUPPLEMENTARY INFORMATION: Associate Commissioner for Policy. manner detailed (see ‘‘Written/Paper
[FR Doc. 2015–25353 Filed 10–5–15; 8:45 am] Submissions’’ and ‘‘Instructions’’).
I. Background
BILLING CODE 4164–01–P Written/Paper Submissions
FDA is announcing the availability of
an eCTD Technical Conformance Guide, Submit written/paper submissions as
Version 1.0. The eCTD Technical DEPARTMENT OF HEALTH AND follows:
HUMAN SERVICES • Mail/Hand delivery/Courier (for
Conformance Guide supplements the
written/paper submissions): Division of
final guidance for industry ‘‘Providing
Food and Drug Administration Dockets Management (HFA–305), Food
Regulatory Submissions in Electronic
and Drug Administration, 5630 Fishers
Format—Certain Human Pharmaceutical [Docket No. FDA–2015–D–1659] Lane, Rm. 1061, Rockville, MD 20852.
Product Applications and Related • For written/paper comments
Submissions Using the eCTD Established Conditions: Reportable
submitted to the Division of Dockets
Specification’’ (eCTD Guidance) and Chemistry, Manufacturing, and
Management, FDA will post your
provides specifications, Controls Changes for Approved Drug
comment, as well as any attachments,
recommendations, and general and Biologic Products; Draft Guidance
except for information submitted,
considerations on how to submit eCTD- for Industry; Reopening of the
marked, and identified as confidential,
based electronic submission to CDER or Comment Period if submitted as detailed in
CBER. The eCTD guidance will AGENCY: Food and Drug Administration, ‘‘Instructions.’’
implement the electronic submission HHS. Instructions: All submissions received
requirements of section 745A(a) of the must include the Docket No. FDA–
Notice; reopening of the
ACTION:
Food, Drug & Cosmetic Act with respect 2015–D–1659 for Established
comment period.
to electronic submissions for certain Conditions: Reportable Chemistry,
investigational new drug applications SUMMARY: The Food and Drug Manufacturing, and Controls Changes
(INDs); new drug applications (NDAs); Administration (FDA) is reopening the for Approved Drug and Biologic
abbreviated new drug comment period for the ‘‘Established Products; Draft Guidance for Industry;
applications(ANDAs); certain biologics Conditions: Reportable Chemistry, Reopening of the Comment Period.
license applications(BLAs); and Master Manufacturing, and Controls (CMC) Received comments will be placed in
Files that are submitted to the CDER or Changes for Approved Drug and the docket and, except for those
CBER. Biologic Products; Draft Guidance for submitted as ‘‘Confidential
The Guide provides specifications, Industry,’’ published in the Federal Submissions,’’ publicly viewable at
recommendations, and general Register of June 1, 2015. FDA is http://www.regulations.gov or at the
considerations on how to submit eCTD- reopening the comment period to allow Division of Dockets Management
based electronic submissions to CDER interested persons additional time to between 9 a.m. and 4 p.m., Monday
or CBER and is intended to complement submit comments. through Friday.
and promote interactions between DATES: Submit either electronic or • Confidential Submissions—To
sponsors and applicants and FDA’s written comments by January 4, 2016. submit a comment with confidential
review divisions. It is not intended to ADDRESSES: You may submit comments information that you do not wish to be
replace the need for sponsors and as follows: made publicly available, submit your
applicants to communicate directly with comments only as a written/paper
review divisions regarding their eCTD- Electronic Submissions submission. You should submit two
based submissions. The Guide is Submit electronic comments in the copies total. One copy will include the
organized as follows: following way: information you claim to be confidential
• Section 1: Introduction—provides • Federal eRulemaking Portal: http:// with a heading or cover note that states
information on regulatory policy and www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
guidance background, purpose, and instructions for submitting comments. CONFIDENTIAL INFORMATION’’. The
document control. Comments submitted electronically, Agency will review this copy, including
• Section 2: General Considerations— including attachments, to http:// the claimed confidential information, in
recommends and provides general www.regulations.gov will be posted to its consideration of comments. The
details on preparing an eCTD the docket unchanged. Because your second copy, which will have the
submission. comment will be made public, you are claimed confidential information
• Section 3: Organization of the solely responsible for ensuring that your redacted/blacked out, will be available
eCTD—presents specific topics comment does not include any for public viewing and posted on
organized by their placement (by confidential information that you or a http://www.regulations.gov. Submit
module) in the eCTD submission. third party may not wish to be posted, both copies to the Division of Dockets
• Section 4: Issues and Solutions— such as medical information, your or Management. If you do not wish your
presents instructions for correcting anyone else’s Social Security number, or name and contact information to be
common problems seen in eCTD confidential business information, such made publicly available, you can
submissions. as a manufacturing process. Please note provide this information on the cover
that if you include your name, contact sheet and not in the body of your
II. Electronic Access
tkelley on DSK3SPTVN1PROD with NOTICES
information, or other information that comments and you must identify this
Persons with access to the Internet identifies you in the body of your information as ‘‘confidential.’’ Any
may obtain the Guide at either http:// comments, that information will be information marked as ‘‘confidential’’
www.fda.gov/forindustry/ posted on http://www.regulations.gov. will not be disclosed except in
datastandards/studydatastandards/ • If you want to submit a comment accordance with 21 CFR 10.20 and other
default.htm or http:// with confidential information that you applicable disclosure law. For more
www.regulations.gov. do not wish to be made available to the information about FDA’s posting of
VerDate Sep<11>2014 18:31 Oct 05, 2015 Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\06OCN1.SGM 06OCN1](https://thefederalregister.org/doc/80_FR_60582/page/2.svg)
Document Created: 2015-12-15 08:50:48
Document Modified: 2015-12-15 08:50:48
| 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 this notice at any time, to ensure that the Agency considers your comments, submit either electronic or written comments by November 20, 2015. | |
| Contact | Ron Fitzmartin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-0002, [email protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 80 FR 60389 |
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