82 FR 28664 - Submission of Proposed Recommendations for Industry on Developing Continuous Manufacturing of Solid Dosage Drug Products in Pharmaceutical Manufacturing; Establishment of a Public Docket
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 120 (June 23, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 120 (June 23, 2017)
| Page Range | 28664-28665 | |
| FR Document | 2017-13195 |
[Federal Register Volume 82, Number 120 (Friday, June 23, 2017)] [Notices] [Pages 28664-28665] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-13195] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-2697] Submission of Proposed Recommendations for Industry on Developing Continuous Manufacturing of Solid Dosage Drug Products in Pharmaceutical Manufacturing; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of docket; request for comments. ----------------------------------------------------------------------- SUMMARY: In connection with promoting the use of innovative technologies, the Food and Drug Administration (FDA or Agency) is establishing a public docket to invite discussion of issues related to the adoption of continuous manufacturing by the pharmaceutical industry. DATES: Submit electronic or written comments by September 21, 2017. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 21, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 21, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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-N-2697 for ``Submission of Proposed Recommendations for Industry on Developing Continuous Manufacturing of Solid Dosage Drug Products in Pharmaceutical Manufacturing; Establishment of a Public Docket.'' Received comments, those filed in a timely manner (see ADDRESSES), 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 ``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. [[Page 28665]] Submit written requests for single copies of the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) document 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the C-SOPS document. FOR FURTHER INFORMATION CONTACT: Sau (Larry) Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2128, Silver Spring, MD 20993-0002, 301- 796-2905, [email protected]. SUPPLEMENTARY INFORMATION: I. Background During a May 7, 2015, workshop on the Future of Pharmaceutical Manufacturing, FDA agreed that interested parties could submit for Agency consideration draft guidance or other materials discussing the science, technology, and best practices related to continuous manufacturing. On June 13, 2016, C-SOPS submitted to FDA an industry- coordinated best practices document on continuous manufacturing. FDA is interested in public comments about the science, technology, and practices discussed in the C-SOPS document and is opening this docket for that purpose. In addition, FDA is seeking comments on other recommendations regarding continuous manufacturing that have already been published, including ``Regulatory and Quality Considerations for Continuous Manufacturing: May 20-21, 2014, Continuous Manufacturing Symposium.'' FDA invites comment on control strategy, facility, and process validation considerations for continuous manufacturing of solid oral dosage forms. This request is not limited to comments on the proposal described in the C-SOPS submission. II. Electronic Access Persons with access to the Internet may obtain the C-SOPS document at https://www.regulations.gov. Dated: June 15, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-13195 Filed 6-22-17; 8:45 am] BILLING CODE 4164-01-P
![28664 Federal Register / Vol. 82, No. 120 / Friday, June 23, 2017 / Notices
administrative medicine, engineering, SUMMARY: In connection with promoting Staff, FDA will post your comment, as
biological and physical sciences, the use of innovative technologies, the well as any attachments, except for
statistics, and other related professions. Food and Drug Administration (FDA or information submitted, marked and
The nature of specialized training and Agency) is establishing a public docket identified, as confidential, if submitted
experience necessary to qualify the to invite discussion of issues related to as detailed in ‘‘Instructions.’’
nominee as an expert suitable for the adoption of continuous Instructions: All submissions received
appointment may include experience in manufacturing by the pharmaceutical must include the Docket No. FDA–
medical practice, teaching, and/or industry. 2017–N–2697 for ‘‘Submission of
research relevant to the field of activity Proposed Recommendations for
DATES: Submit electronic or written
of the panel. The particular needs at this Industry on Developing Continuous
comments by September 21, 2017.
time for each panel are listed in table 2 Manufacturing of Solid Dosage Drug
ADDRESSES: You may submit comments Products in Pharmaceutical
of this document. Members will be
as follows. Please note that late, Manufacturing; Establishment of a
invited to serve for terms of up to 4
untimely filed comments will not be Public Docket.’’ Received comments,
years.
considered. Electronic comments must those filed in a timely manner (see
III. Nomination Procedures be submitted on or before September 21, ADDRESSES), will be placed in the docket
Any interested person may nominate 2017. The https://www.regulations.gov and, except for those submitted as
one or more qualified individuals for electronic filing system will accept ‘‘Confidential Submissions,’’ publicly
membership on one or more of the comments until midnight Eastern Time viewable at https://www.regulations.gov
advisory panels or advisory committees. at the end of September 21, 2017. or at the Dockets Management Staff
Self-nominations are also accepted. Comments received by mail/hand between 9 a.m. and 4 p.m., Monday
Nominations must include a current, delivery/courier (for written/paper through Friday.
complete resume or curriculum vitae for submissions) will be considered timely • Confidential Submissions—To
each nominee, including current if they are postmarked or the delivery submit a comment with confidential
business address and/or home address, service acceptance receipt is on or information that you do not wish to be
telephone number, and email address if before that date. made publicly available, submit your
available. Nominations must also Electronic Submissions comments only as a written/paper
specify the advisory committee(s) for submission. You should submit two
Submit electronic comments in the copies total. One copy will include the
which the nominee is recommended.
following way: information you claim to be confidential
Nominations must also acknowledge
• Federal eRulemaking Portal: with a heading or cover note that states
that the nominee is aware of the
https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
nomination unless self-nominated. FDA
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
will ask potential candidates to provide
Comments submitted electronically, Agency will review this copy, including
detailed information concerning such
including attachments, to https:// the claimed confidential information, in
matters related to financial holdings,
www.regulations.gov will be posted to its consideration of comments. The
employment, and research grants and/or
the docket unchanged. Because your second copy, which will have the
contracts to permit evaluation of
comment will be made public, you are claimed confidential information
possible sources of conflict of interest.
solely responsible for ensuring that your redacted/blacked out, will be available
This notice is issued under the
comment does not include any for public viewing and posted on
Federal Advisory Committee Act (5
confidential information that you or a https://www.regulations.gov. Submit
U.S.C. app. 2) and 21 CFR part 14,
third party may not wish to be posted, both copies to the Dockets Management
relating to advisory committees.
such as medical information, your or Staff. If you do not wish your name and
Dated: June 20, 2017. anyone else’s Social Security number, or contact information to be made publicly
Anna K. Abram, confidential business information, such available, you can provide this
Deputy Commissioner for Policy, Planning, as a manufacturing process. Please note information on the cover sheet and not
Legislation, and Analysis. that if you include your name, contact in the body of your comments and you
[FR Doc. 2017–13182 Filed 6–22–17; 8:45 am] information, or other information that must identify this information as
BILLING CODE 4164–01–P identifies you in the body of your ‘‘confidential.’’ Any information marked
comments, that information will be as ‘‘confidential’’ will not be disclosed
posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
DEPARTMENT OF HEALTH AND • If you want to submit a comment and other applicable disclosure law. For
HUMAN SERVICES with confidential information that you more information about FDA’s posting
do not wish to be made available to the of comments to public dockets, see 80
Food and Drug Administration public, submit the comment as a FR 56469, September 18, 2015, or access
written/paper submission and in the the information at: https://www.gpo.gov/
[Docket No. FDA–2017–N–2697] manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
Submissions’’ and ‘‘Instructions’’). 23389.pdf.
Submission of Proposed Docket: For access to the docket to
Recommendations for Industry on Written/Paper Submissions read background documents or the
Developing Continuous Manufacturing
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Submit written/paper submissions as electronic and written/paper comments
of Solid Dosage Drug Products in follows: received, go to https://
Pharmaceutical Manufacturing; • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Establishment of a Public Docket written/paper submissions): Dockets docket number, found in brackets in the
AGENCY: Food and Drug Administration, Management Staff (HFA–305), Food and heading of this document, into the
HHS. Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
ACTION: Notice; establishment of docket;
• For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
request for comments.
submitted to the Dockets Management Rockville, MD 20852.
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![Federal Register / Vol. 82, No. 120 / Friday, June 23, 2017 / Notices 28665
Submit written requests for single DEPARTMENT OF HEALTH AND Electronic Submissions
copies of the Engineering Research HUMAN SERVICES Submit electronic comments in the
Center for Structured Organic following way:
Particulate Systems (C-SOPS) document Food and Drug Administration
• Federal eRulemaking Portal:
to the Division of Drug Information, [Docket No. FDA–2017–N–3067] https://www.regulations.gov. Follow the
Center for Drug Evaluation and instructions for submitting comments.
Research, Food and Drug Patient-Focused Drug Development for Comments submitted electronically,
Administration, 10903 New Hampshire Alopecia Areata; Public Meeting; including attachments, to https://
Ave., Bldg. 51, Rm. 2201, Silver Spring, Request for Comments www.regulations.gov will be posted to
MD 20993–0002. Send one self- the docket unchanged. Because your
addressed adhesive label to assist that AGENCY: Food and Drug Administration,
HHS. comment will be made public, you are
office in processing your requests. See solely responsible for ensuring that your
the SUPPLEMENTARY INFORMATION section ACTION: Notice of public meeting;
request for comments. comment does not include any
for electronic access to the C-SOPS confidential information that you or a
document. SUMMARY: The Food and Drug third party may not wish to be posted,
FOR FURTHER INFORMATION CONTACT: Sau Administration (FDA, the Agency, or such as medical information, your or
(Larry) Lee, Center for Drug Evaluation we) is announcing a public meeting and anyone else’s Social Security number, or
and Research, Food and Drug an opportunity for public comment on confidential business information, such
Administration, 10903 New Hampshire ‘‘Patient-Focused Drug Development for as a manufacturing process. Please note
Ave., Bldg. 22, Rm. 2128, Silver Spring, Alopecia Areata.’’ Patient-Focused Drug that if you include your name, contact
MD 20993–0002, 301–796–2905, Development is part of FDA’s information, or other information that
Sau.Lee@fda.hhs.gov. performance commitments under the identifies you in the body of your
fifth authorization of the Prescription comments, that information will be
SUPPLEMENTARY INFORMATION: Drug User Fee Act (PDUFA V). The posted on https://www.regulations.gov.
I. Background
public meeting is intended to allow • If you want to submit a comment
FDA to obtain patients’ perspectives on with confidential information that you
During a May 7, 2015, workshop on the impact of alopecia areata, including do not wish to be made available to the
the Future of Pharmaceutical on daily life. FDA is also seeking public, submit the comment as a
Manufacturing, FDA agreed that patients’ views on treatment approaches written/paper submission and in the
interested parties could submit for and decision factors taken into account manner detailed (see ‘‘Written/Paper
Agency consideration draft guidance or when selecting a treatment. Submissions’’ and ‘‘Instructions’’).
other materials discussing the science, DATES: The public meeting will be held
on September 11, 2017, from 1 p.m. to Written/Paper Submissions
technology, and best practices related to
continuous manufacturing. On June 13, 5 p.m. Submit either electronic or Submit written/paper submissions as
2016, C-SOPS submitted to FDA an written comments on this public follows:
industry-coordinated best practices meeting by November 13, 2017. See the • Mail/Hand delivery/Courier (for
document on continuous SUPPLEMENTARY INFORMATION section for written/paper submissions): Dockets
manufacturing. FDA is interested in registration date and information. Management Staff (HFA–305), Food and
public comments about the science, ADDRESSES: The public meeting will be Drug Administration, 5630 Fishers
technology, and practices discussed in held at the FDA White Oak Campus, Lane, Rm. 1061, Rockville, MD 20852.
the C-SOPS document and is opening 10903 New Hampshire Ave., Bldg. 31 • For written/paper comments
this docket for that purpose. In addition, Conference Center, the Great Room (Rm. submitted to the Dockets Management
FDA is seeking comments on other 1503), Silver Spring, MD 20993–0002. Staff, FDA will post your comment, as
recommendations regarding continuous Entrance for the public meeting well as any attachments, except for
manufacturing that have already been participants (non-FDA employees) is information submitted, marked and
published, including ‘‘Regulatory and through Building 1 where routine identified, as confidential, if submitted
Quality Considerations for Continuous security check procedures will be as detailed in ‘‘Instructions.’’
Manufacturing: May 20–21, 2014, performed. For more information on Instructions: All submissions received
Continuous Manufacturing parking and security procedures, please must include the Docket No. FDA–
Symposium.’’ FDA invites comment on refer to http://www.fda.gov/AboutFDA/ 2017–N–3067 for ‘‘Patient-Focused Drug
control strategy, facility, and process WorkingatFDA/BuildingsandFacilities/ Development for Alopecia Areata.’’
validation considerations for continuous WhiteOakCampusInformation/ Received comments, those filed in a
manufacturing of solid oral dosage ucm241740.htm. timely manner (see ADDRESSES), will be
forms. This request is not limited to You may submit comments as placed in the docket and, except for
comments on the proposal described in follows. Please note that late, untimely those submitted as ‘‘Confidential
the C-SOPS submission. filed comments will not be considered. Submissions,’’ publicly viewable at
Electronic comments must be submitted https://www.regulations.gov or at the
II. Electronic Access on or before November 13, 2017. The Dockets Management Staff between 9
Persons with access to the Internet https://www.regulations.gov electronic a.m. and 4 p.m., Monday through
asabaliauskas on DSKBBXCHB2PROD with NOTICES
may obtain the C-SOPS document at filing system will accept comments Friday.
https://www.regulations.gov. until midnight Eastern Time at the end • Confidential Submissions—To
of November 13, 2017. Comments submit a comment with confidential
Dated: June 15, 2017. received by mail/hand delivery/courier information that you do not wish to be
Anna K. Abram, (for written/paper submissions) will be made publicly available, submit your
Deputy Commissioner for Policy, Planning, considered timely if they are comments only as a written/paper
Legislation, and Analysis. postmarked or the delivery service submission. You should submit two
[FR Doc. 2017–13195 Filed 6–22–17; 8:45 am] acceptance receipt is on or before that copies total. One copy will include the
BILLING CODE 4164–01–P date. information you claim to be confidential
VerDate Sep<11>2014 19:21 Jun 22, 2017 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\23JNN1.SGM 23JNN1](https://thefederalregister.org/doc/82_FR_28784/page/2.svg)
Document Created: 2017-06-23 03:37:22
Document Modified: 2017-06-23 03:37:22
| 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; establishment of docket; request for comments. | |
| Dates | Submit electronic or written comments by September 21, 2017. | |
| Contact | Sau (Larry) Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2128, Silver Spring, MD 20993-0002, 301- 796-2905, [email protected] | |
| FR Citation | 82 FR 28664 |
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