80 FR 60390 - Established Conditions: Reportable Chemistry, Manufacturing, and Controls Changes for Approved Drug and Biologic Products; Draft Guidance for Industry; Reopening of the Comment Period
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 | 60390-60391 | |
| FR Document | 2015-25356 |
[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)] [Notices] [Pages 60390-60391] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25356] ----------------------------------------------------------------------- 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Conditions: Reportable Chemistry, Manufacturing, and Controls Changes for Approved Drug and Biologic Products; Draft Guidance for Industry; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS.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Conditions: Reportable Chemistry, Manufacturing, and Controls (CMC) Changes for Approved Drug and Biologic Products; Draft Guidance for Industry,'' published in the Federal Register of June 1, 2015.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: 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-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 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 [[Page 60391]] 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 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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://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
![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
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![Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices 60391
comments to public dockets, see 80 FR decision-making on these important ADDRESSES: You may submit comments
56469, September 18, 2015, or access issues. as follows:
the information at: http://www.fda.gov/
II. Electronic Access Electronic Submissions
regulatoryinformation/dockets/
default.htm. Persons with access to the Internet Submit electronic comments in the
Docket: For access to the docket to may obtain the draft guidance at following way:
read background documents or the http://www.fda.gov/Drugs/Guidance • Federal eRulemaking Portal: http://
electronic and written/paper comments ComplianceRegulatoryInformation/ www.regulations.gov. Follow the
received, go to http:// Guidances/default.htm, http:// instructions for submitting comments.
www.regulations.gov and insert the www.fda.gov/BiologicsBloodVaccines/ Comments submitted electronically,
docket number, found in brackets in the GuidanceComplianceRegulatory including attachments, to http://
heading of this document, into the Information/default.htm, or http:// www.regulations.gov will be posted to
‘‘Search’’ box and follow the prompts www.regulations.gov. the docket unchanged. Because your
and/or go to the Division of Dockets comment will be made public, you are
Dated: September 30, 2015.
Management, 5630 Fishers Lane, Rm. solely responsible for ensuring that your
Leslie Kux, comment does not include any
1061, Rockville, MD 20852. Associate Commissioner for Policy. confidential information that you or a
Submit written requests for single [FR Doc. 2015–25356 Filed 10–5–15; 8:45 am] third party may not wish to be posted,
copies of the draft guidance to the BILLING CODE 4164–01–P such as medical information, your or
Division of Drug Information, Center for anyone else’s Social Security number, or
Drug Evaluation and Research, Food confidential business information, such
and Drug Administration, 10001 New DEPARTMENT OF HEALTH AND as a manufacturing process. Please note
Hampshire Ave., Hillandale Building, HUMAN SERVICES that if you include your name, contact
4th Floor, Silver Spring, MD 20993– information, or other information that
0002; or Office of Communication, Food and Drug Administration
identifies you in the body of your
Outreach and Development, Center for comments, that information will be
Biologics Evaluation and Research, [Docket No. FDA–2015–N–3402] posted on http://www.regulations.gov.
Food and Drug Administration, 10903 • If you want to submit a comment
New Hampshire Ave., Bldg. 71, Rm. Electronic Submission of Final with confidential information that you
3128, Silver Spring, MD 20993–0002. Approved Risk Evaluation and do not wish to be made available to the
Send one self-addressed adhesive label Mitigation Strategies and Summary public, submit the comment as a
to assist the office in processing your Information in a Standard Structured written/paper submission and in the
requests. The draft guidance may also be Product Labeling Format; Pilot Project manner detailed (see ‘‘Written/Paper
obtained by mail by calling CBER at 1– Submissions’’ and ‘‘Instructions’’).
800–835–4709 or 240–402–8010. See AGENCY: Food and Drug Administration,
the SUPPLEMENTARY INFORMATION section HHS. Written/Paper Submissions
for electronic access to the draft ACTION:Notice of pilot project, request Submit written/paper submissions as
guidance document. for comments. follows:
FOR FURTHER INFORMATION CONTACT: • Mail/Hand delivery/Courier (for
SUMMARY: The Food and Drug written/paper submissions): Division of
Ashley Boam, Center for Drug Administration (FDA or Agency) is
Evaluation and Research, Food and Dockets Management (HFA–305), Food
announcing a pilot project for the and Drug Administration, 5630 Fishers
Drug Administration, 10903 New submission of final approved Risk
Hampshire Ave., Bldg. 51, Rm. 4192, Lane, Rm. 1061, Rockville, MD 20852.
Evaluation and Mitigation Strategies • For written/paper comments
Silver Spring, MD 20993, 301–796– (REMS) and certain REMS summary
2400; or Stephen Ripley, Center for submitted to the Division of Dockets
information electronically in a standard Management, FDA will post your
Biologics Evaluation and Research, Structured Product Labeling (SPL)
Food and Drug Administration, 10903 comment, as well as any attachments,
format. Participation in the pilot is except for information submitted,
New Hampshire Ave., Bldg. 71, Rm. voluntary and is open to application
7301, Silver Spring, MD 20993, 240– marked and identified, as confidential,
holders of drugs with REMS. The pilot if submitted as detailed in
402–7911. is intended to help application holders, ‘‘Instructions.’’
SUPPLEMENTARY INFORMATION: FDA, and other interested stakeholders Instructions: All submissions received
evaluate a potential approach to must include the Docket No. FDA–
I. Background converting REMS into SPL format and 2015–N–3402 for ‘‘Electronic
In the Federal Register of June 1, 2015 evaluate the usefulness of the REMS Submission of Final Approved Risk
(80 FR 31050), FDA announced the information to be provided in SPL Evaluation and Mitigation Strategies
availability of a draft guidance for format. This project also will help and Summary Information in a Standard
industry entitled ‘‘Established provide FDA with feedback on these Structured Product Labeling Format;
Conditions: Reportable CMC Changes topics from pilot participants and other Pilot Project.’’ Received comments will
for Approved Drug and Biologic interested stakeholders. be placed in the docket and, except for
Products.’’ Interested persons were DATES: Submit requests to participate in those submitted as ‘‘Confidential
originally given until July 31, 2015, to the REMS SPL pilot from October 6, Submissions,’’ publicly viewable at
tkelley on DSK3SPTVN1PROD with NOTICES
comment on the draft guidance. The 2015 to December 7, 2015. See the http://www.regulations.gov or at the
Agency believes that reopening the ‘‘Participation’’ section for instructions Division of Dockets Management
comment period for an additional 90 on how to submit a request to between 9 a.m. and 4 p.m., Monday
days from the date of publication of this participate. The pilot will proceed for 4 through Friday.
notice will allow adequate time for months, from October 6, 2015 to • Confidential Submissions—To
interested persons to submit comments February 3, 2016. This pilot may be submit a comment with confidential
without significantly delaying Agency extended as resources and needs allow. information that you do not wish to be
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Document Created: 2015-12-15 08:51:08
Document Modified: 2015-12-15 08:51:08
| 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; reopening of the comment period. | |
| Dates | Submit either electronic or written comments by January 4, 2016. | |
| 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. | |
| FR Citation | 80 FR 60390 |
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