83 FR 6195 - Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 30 (February 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 30 (February 13, 2018)
| Page Range | 6195-6196 | |
| FR Document | 2018-02871 |
[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)] [Notices] [Pages 6195-6196] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02871] [[Page 6195]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-0342] Bacillus Calmette-Gu[eacute]rin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Bacillus Calmette-Gu[eacute]rin (BCG)-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.'' This guidance was developed to assist in the development of drugs and biologics for patients with a form of bladder cancer that is not amenable to currently available medical therapy and remains an unmet medical need. This guidance finalizes the draft guidance of the same name issued on November 18, 2016. DATES: The announcement of the guidance is published in the Federal Register on February 13, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time 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): 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-2018-D-0342 for ``BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Guidance for Industry.'' 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 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this 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 that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: V. Ellen Maher, Center for Drug Evaluation and Research, Food and Drug Administration,10903 New Hampshire Ave., Bldg. 22, Rm. 2352, Silver Spring, MD 20993-0002, 301- 796-5017; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.'' This guidance was developed to assist in the development of drugs and biologics for patients with a form of bladder cancer that is not amenable to currently available medical therapy and remains an unmet medical need. This guidance finalizes the draft guidance of the same name issued on November 18, 2016 (81 FR 81778). Changes made to the guidance took into consideration written and verbal comments received. In addition to editorial changes made primarily for clarification, noteworthy substantive changes are as follows: Clarification of the definition of BCG-unresponsive disease and detailed [[Page 6196]] information concerning the definition of complete response. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on BCG-unresponsive nonmuscle invasive bladder cancer. 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. This guidance is not subject to Executive Order 12866. II. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Dated: February 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02871 Filed 2-12-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices 6195
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). read background documents or the
electronic and written/paper comments
Food and Drug Administration Written/Paper Submissions
received, go to https://
[Docket No. FDA–2018–D–0342] Submit written/paper submissions as www.regulations.gov and insert the
follows: docket number, found in brackets in the
Bacillus Calmette-Guérin- • Mail/Hand delivery/Courier (for heading of this document, into the
Unresponsive Nonmuscle Invasive written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Bladder Cancer: Developing Drugs and Management Staff (HFA–305), Food and and/or go to the Dockets Management
Biologics for Treatment; Guidance for Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Industry; Availability Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
• For written/paper comments You may submit comments on any
AGENCY: Food and Drug Administration, guidance at any time (see 21 CFR
submitted to the Dockets Management
HHS. 10.115(g)(5)).
Staff, FDA will post your comment, as
ACTION: Notice of availability. well as any attachments, except for Submit written requests for single
SUMMARY: The Food and Drug information submitted, marked and copies of this guidance to the Division
Administration (FDA or Agency) is identified, as confidential, if submitted of Drug Information, Center for Drug
announcing the availability of a as detailed in ‘‘Instructions.’’ Evaluation and Research, Food and
guidance for industry entitled ‘‘Bacillus Instructions: All submissions received Drug Administration, 10001 New
Calmette-Guérin (BCG)-Unresponsive must include the Docket No. FDA– Hampshire Ave., Hillandale Building,
Nonmuscle Invasive Bladder Cancer: 2018–D–0342 for ‘‘BCG-Unresponsive 4th Floor, Silver Spring, MD 20993–
Developing Drugs and Biologics for Nonmuscle Invasive Bladder Cancer: 0002, or Office of Communication,
Treatment.’’ This guidance was Developing Drugs and Biologics for Outreach, and Development, Center for
developed to assist in the development Treatment; Guidance for Industry.’’ Biologics Evaluation and Research,
of drugs and biologics for patients with Received comments will be placed in Food and Drug Administration, 10903
a form of bladder cancer that is not the docket and, except for those New Hampshire Ave., Bldg. 71, Rm.
amenable to currently available medical submitted as ‘‘Confidential 3128, Silver Spring, MD 20993–0002.
therapy and remains an unmet medical Submissions,’’ publicly viewable at Send one self-addressed adhesive label
need. This guidance finalizes the draft https://www.regulations.gov or at the to assist that office in processing your
guidance of the same name issued on Dockets Management Staff between 9 requests. See the SUPPLEMENTARY
November 18, 2016. a.m. and 4 p.m., Monday through INFORMATION section for electronic
Friday. access to the guidance document.
DATES: The announcement of the
guidance is published in the Federal • Confidential Submissions—To FOR FURTHER INFORMATION CONTACT:
Register on February 13, 2018. submit a comment with confidential V. Ellen Maher, Center for Drug
ADDRESSES: You may submit either information that you do not wish to be Evaluation and Research, Food and
electronic or written comments on made publicly available, submit your Drug Administration,10903 New
Agency guidances at any time as comments only as a written/paper Hampshire Ave., Bldg. 22, Rm. 2352,
follows: submission. You should submit two Silver Spring, MD 20993–0002, 301–
copies total. One copy will include the 796–5017; or Stephen Ripley, Center for
Electronic Submissions information you claim to be confidential Biologics Evaluation and Research,
Submit electronic comments in the with a heading or cover note that states Food and Drug Administration, 10903
following way: ‘‘THIS DOCUMENT CONTAINS New Hampshire Ave., Bldg. 71, Rm.
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The 7301, Silver Spring, MD 20993–0002,
https://www.regulations.gov. Follow the Agency will review this copy, including 240–402–7911.
instructions for submitting comments. the claimed confidential information, in SUPPLEMENTARY INFORMATION:
Comments submitted electronically, its consideration of comments. The
second copy, which will have the I. Background
including attachments, to https://
www.regulations.gov will be posted to claimed confidential information FDA is announcing the availability of
the docket unchanged. Because your redacted/blacked out, will be available a guidance for industry entitled ‘‘BCG-
comment will be made public, you are for public viewing and posted on Unresponsive Nonmuscle Invasive
solely responsible for ensuring that your https://www.regulations.gov. Submit Bladder Cancer: Developing Drugs and
comment does not include any both copies to the Dockets Management Biologics for Treatment.’’ This guidance
confidential information that you or a Staff. If you do not wish your name and was developed to assist in the
third party may not wish to be posted, contact information to be made publicly development of drugs and biologics for
such as medical information, your or available, you can provide this patients with a form of bladder cancer
anyone else’s Social Security number, or information on the cover sheet and not that is not amenable to currently
confidential business information, such in the body of your comments and you available medical therapy and remains
as a manufacturing process. Please note must identify this information as an unmet medical need. This guidance
that if you include your name, contact ‘‘confidential.’’ Any information marked finalizes the draft guidance of the same
information, or other information that as ‘‘confidential’’ will not be disclosed name issued on November 18, 2016 (81
except in accordance with 21 CFR 10.20 FR 81778). Changes made to the
sradovich on DSK3GMQ082PROD with NOTICES
identifies you in the body of your
comments, that information will be and other applicable disclosure law. For guidance took into consideration
posted on https://www.regulations.gov. more information about FDA’s posting written and verbal comments received.
• If you want to submit a comment of comments to public dockets, see 80 In addition to editorial changes made
with confidential information that you FR 56469, September 18, 2015, or access primarily for clarification, noteworthy
do not wish to be made available to the the information at: https://www.gpo.gov/ substantive changes are as follows:
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- Clarification of the definition of BCG-
written/paper submission and in the 23389.pdf. unresponsive disease and detailed
VerDate Sep<11>2014 23:12 Feb 12, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\13FEN1.SGM 13FEN1](https://thefederalregister.org/doc/83_FR_6225/page/1.svg)
![6196 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices
information concerning the definition of Pharmaceutical Manufacturing Research manner detailed (see ‘‘Written/Paper
complete response. Services, Inc. (PMRS) for oxycodone Submissions’’ and ‘‘Instructions’’).
This guidance is being issued hydrochloride (HCl) immediate-release
consistent with FDA’s good guidance Written/Paper Submissions
(IR) oral capsules, 5 milligrams (mg), 15
practices regulation (21 CFR 10.115). mg, and 30 mg in its present form. This Submit written/paper submissions as
The guidance represents the current notice summarizes the grounds for the follows:
thinking of FDA on BCG-unresponsive Center Director’s proposal and offers • Mail/Hand delivery/Courier (for
nonmuscle invasive bladder cancer. It PMRS an opportunity to request a written/paper submissions): Dockets
does not establish any rights for any hearing on the matter. Management Staff (HFA–305), Food and
person and is not binding on FDA or the Drug Administration, 5630 Fishers
DATES: Submit either electronic or
public. You can use an alternative Lane, Rm. 1061, Rockville, MD 20852.
written requests for a hearing by March • For written/paper comments
approach if it satisfies the requirements 15, 2018; submit data, information, and
of the applicable statutes and submitted to the Dockets Management
analyses in support of the hearing and Staff, FDA will post your comment, as
regulations. This guidance is not subject any other comments by April 16, 2018.
to Executive Order 12866. well as any attachments, except for
ADDRESSES: You may submit hearing information submitted, marked and
II. The Paperwork Reduction Act of requests, documents in support of the identified, as confidential, if submitted
1995 hearing, and any other comments as as detailed in ‘‘Instructions.’’
This guidance refers to previously follows. Please note that late, untimely Instructions: All submissions received
approved collections of information that filed requests and documents will not must include the Docket No. FDA–
are subject to review by the Office of be considered. Electronic requests for a 2018–N–0188, for ‘‘Proposal to Refuse to
Management and Budget (OMB) under hearing must be submitted on or before Approve a New Drug Application for
the Paperwork Reduction Act of 1995 March 15, 2018; electronic documents Oxycodone Hydrochloride Immediate-
(44 U.S.C. 3501–3520). The collections in support of the hearing and any other Release Oral Capsules, 5 Milligrams, 15
of information in 21 CFR parts 312 and comments must be submitted on or Milligrams, and 30 Milligrams;
314 have been approved under OMB before April 16, 2018. The https:// Opportunity for a Hearing.’’ Received
control numbers 0910–0014 and 0910– www.regulations.gov electronic filing comments, those filed in a timely
0001, respectively. system will accept hearing requests manner (see ADDRESSES), will be placed
until midnight Eastern Time at the end in the docket and, except for those
III. Electronic Access of March 15, 2018, and will accept submitted as ‘‘Confidential
Persons with access to the internet documents in support of the hearing Submissions,’’ publicly viewable at
may obtain the guidance at either and any other comments until midnight https://www.regulations.gov or at the
https://www.fda.gov/Drugs/Guidance Eastern Time at the end of April 16, Dockets Management Staff between 9
ComplianceRegulatoryInformation/ 2018. Documents received by mail/hand a.m. and 4 p.m., Monday through
Guidances/default.htm, https:// delivery/courier (for written/paper Friday.
www.fda.gov/BiologicsBloodVaccines/ submissions) will be considered timely • Confidential Submissions—To
GuidanceComplianceRegulatory if they are postmarked or the delivery submit a comment with confidential
Information/default.htm, or https:// service acceptance receipt is on or information that you do not wish to be
www.regulations.gov. before these dates. made publicly available, submit your
comments only as a written/paper
Dated: February 7, 2018. Electronic Submissions submission. You should submit two
Leslie Kux, Submit electronic comments in the copies total. One copy will include the
Associate Commissioner for Policy. following way: information you claim to be confidential
[FR Doc. 2018–02871 Filed 2–12–18; 8:45 am] • Federal eRulemaking Portal: with a heading or cover note that states
BILLING CODE 4164–01–P https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
Comments submitted electronically, Agency will review this copy, including
DEPARTMENT OF HEALTH AND including attachments, to https:// the claimed confidential information, in
HUMAN SERVICES www.regulations.gov will be posted to its consideration of comments. The
the docket unchanged. Because your second copy, which will have the
Food and Drug Administration
comment will be made public, you are claimed confidential information
[Docket No. FDA–2018–N–0188] solely responsible for ensuring that your redacted/blacked out, will be available
comment does not include any for public viewing and posted on
Proposal To Refuse To Approve a New confidential information that you or a https://www.regulations.gov. Submit
Drug Application for Oxycodone third party may not wish to be posted, both copies to the Dockets Management
Hydrochloride Immediate-Release Oral such as medical information, your or Staff. If you do not wish your name and
Capsules, 5 Milligrams, 15 Milligrams, anyone else’s Social Security number, or contact information to be made publicly
and 30 Milligrams; Opportunity for a confidential business information, such available, you can provide this
Hearing as a manufacturing process. Please note information on the cover sheet and not
AGENCY: Food and Drug Administration, that if you include your name, contact in the body of your comments and you
HHS. information, or other information that must identify this information as
identifies you in the body of your ‘‘confidential.’’ Any information marked
sradovich on DSK3GMQ082PROD with NOTICES
ACTION: Notice.
comments, that information will be as ‘‘confidential’’ will not be disclosed
SUMMARY: The Director of the Center for posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
Drug Evaluation and Research (Center • If you want to submit a comment and other applicable disclosure law. For
Director) of the Food and Drug with confidential information that you more information about FDA’s posting
Administration (FDA or Agency) is do not wish to be made available to the of comments to public dockets, see 80
proposing to refuse to approve a new public, submit the comment as a FR 56469, September 18, 2015, or access
drug application (NDA) submitted by written/paper submission and in the the information at: https://www.gpo.gov/
VerDate Sep<11>2014 23:12 Feb 12, 2018 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\13FEN1.SGM 13FEN1](https://thefederalregister.org/doc/83_FR_6225/page/2.svg)
Document Created: 2018-02-13 02:32:22
Document Modified: 2018-02-13 02:32:22
| 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 of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on February 13, 2018. | |
| Contact | V. Ellen Maher, Center for Drug Evaluation and Research, Food and Drug Administration,10903 New Hampshire Ave., Bldg. 22, Rm. 2352, Silver Spring, MD 20993-0002, 301- 796-5017; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 83 FR 6195 |
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