Established Conditions: Reportable Chemistry, Manufacturing, and Controls Changes for Approved Drug and Biologic Products; Draft Guidance for Industry; Reopening of the Comment Period, 60390-60391 [2015-25356]

Download as PDF 60390 Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices 71, Rm. 7301, Silver Spring, MD 20993– 0002, 240–402–7911. SUPPLEMENTARY INFORMATION: [FR Doc. 2015–25353 Filed 10–5–15; 8:45 am] I. Background BILLING CODE 4164–01–P tkelley on DSK3SPTVN1PROD with NOTICES 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 eCTDbased 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 eCTDbased 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 eCTDbased 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 https:// www.fda.gov/forindustry/ datastandards/studydatastandards/ default.htm or https:// www.regulations.gov. VerDate Sep<11>2014 18:31 Oct 05, 2015 Dated: September 30, 2015. Leslie Kux, Associate Commissioner for Policy. Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–1659] Established Conditions: Reportable Chemistry, Manufacturing, and Controls Changes for Approved Drug and Biologic Products; Draft Guidance for Industry; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice; reopening of the comment period. ACTION: The Food and Drug Administration (FDA) is reopening the comment period for the ‘‘Established Conditions: Reportable Chemistry, Manufacturing, and Controls (CMC) Changes for Approved Drug and Biologic Products; Draft Guidance for Industry,’’ published in the Federal Register of June 1, 2015. FDA is reopening the comment period to allow interested persons additional time to submit comments. DATES: Submit either electronic or written comments by January 4, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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–1659 for Established Conditions: Reportable Chemistry, Manufacturing, and Controls Changes for Approved Drug and Biologic Products; Draft Guidance for Industry; Reopening of the Comment Period. 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 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 https://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 E:\FR\FM\06OCN1.SGM 06OCN1 Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices 60391 comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://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 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft 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 Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, 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 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 draft guidance document. decision-making on these important issues. ADDRESSES: II. Electronic Access 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’’). FOR FURTHER INFORMATION CONTACT: SUMMARY: Ashley Boam, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4192, Silver Spring, MD 20993, 301–796– 2400; 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, 240– 402–7911. SUPPLEMENTARY INFORMATION: tkelley on DSK3SPTVN1PROD with NOTICES I. Background In the Federal Register of June 1, 2015 (80 FR 31050), FDA announced the availability of a draft guidance for industry entitled ‘‘Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products.’’ Interested persons were originally given until July 31, 2015, to comment on the draft guidance. The Agency believes that reopening the comment period for an additional 90 days from the date of publication of this notice will allow adequate time for interested persons to submit comments without significantly delaying Agency VerDate Sep<11>2014 18:31 Oct 05, 2015 Jkt 238001 Persons with access to the Internet may obtain the draft guidance at https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, or https:// www.regulations.gov. Dated: September 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–25356 Filed 10–5–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–3402] Electronic Submission of Final Approved Risk Evaluation and Mitigation Strategies and Summary Information in a Standard Structured Product Labeling Format; Pilot Project AGENCY: Food and Drug Administration, HHS. Notice of pilot project, request for comments. ACTION: The Food and Drug Administration (FDA or Agency) is announcing a pilot project for the submission of final approved Risk Evaluation and Mitigation Strategies (REMS) and certain REMS summary information electronically in a standard Structured Product Labeling (SPL) format. Participation in the pilot is voluntary and is open to application holders of drugs with REMS. The pilot is intended to help application holders, FDA, and other interested stakeholders evaluate a potential approach to converting REMS into SPL format and evaluate the usefulness of the REMS information to be provided in SPL format. This project also will help provide FDA with feedback on these topics from pilot participants and other interested stakeholders. DATES: Submit requests to participate in the REMS SPL pilot from October 6, 2015 to December 7, 2015. See the ‘‘Participation’’ section for instructions on how to submit a request to participate. The pilot will proceed for 4 months, from October 6, 2015 to February 3, 2016. This pilot may be extended as resources and needs allow. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 You may submit comments as follows: 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–N–3402 for ‘‘Electronic Submission of Final Approved Risk Evaluation and Mitigation Strategies and Summary Information in a Standard Structured Product Labeling Format; Pilot Project.’’ 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 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 E:\FR\FM\06OCN1.SGM 06OCN1

Agencies

[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60390-60391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25356]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1659]


Established Conditions: Reportable Chemistry, Manufacturing, and 
Controls Changes for Approved Drug and Biologic Products; Draft 
Guidance for Industry; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the ``Established Conditions: Reportable Chemistry, 
Manufacturing, and Controls (CMC) Changes for Approved Drug and 
Biologic Products; Draft Guidance for Industry,'' published in the 
Federal Register of June 1, 2015. FDA is reopening the comment period 
to allow interested persons additional time to submit comments.

DATES: Submit either electronic or written comments by January 4, 2016.

ADDRESSES: You may submit comments 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): 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-1659 for Established Conditions: Reportable Chemistry, 
Manufacturing, and Controls Changes for Approved Drug and Biologic 
Products; Draft Guidance for Industry; Reopening of the Comment Period. 
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 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 https://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

[[Page 60391]]

comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://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 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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft 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 Office 
of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, 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 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 draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Ashley Boam, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4192, Silver Spring, MD 20993, 301-796-
2400; 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, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of June 1, 2015 (80 FR 31050), FDA 
announced the availability of a draft guidance for industry entitled 
``Established Conditions: Reportable CMC Changes for Approved Drug and 
Biologic Products.'' Interested persons were originally given until 
July 31, 2015, to comment on the draft guidance. The Agency believes 
that reopening the comment period for an additional 90 days from the 
date of publication of this notice will allow adequate time for 
interested persons to submit comments without significantly delaying 
Agency decision-making on these important issues.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: September 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25356 Filed 10-5-15; 8:45 am]
 BILLING CODE 4164-01-P
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