81 FR 81778 - Bacillus Calmette-Guerin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 223 (November 18, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 223 (November 18, 2016)
| Page Range | 81778-81779 | |
| FR Document | 2016-27762 |
[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)] [Notices] [Pages 81778-81779] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27762] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-3456] Bacillus Calmette-Guerin--Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bacillus Calmette-Guerin (BCG)--Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.'' The purpose of this guidance is to assist sponsors in the development of drugs and biologics to treat patients with a high-risk form of bladder cancer. The alternative is radical cystectomy, a surgical procedure with significant morbidity and mortality. This guidance will help overcome some of the obstacles in conducting the studies needed to establish efficacy of drugs and biologics for these patients with an unmet medical need. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 16, 2017. 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-2016-D-3456] for ``BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Draft Guidance for Industry; Availability.'' 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 draft guidance to the [[Page 81779]] 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 the 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 draft 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 draft guidance for industry entitled ``BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.'' This draft guidance is intended to provide a framework for industry to facilitate the development of drugs and biologics to treat patients with nonmuscle invasive bladder cancer (NMIBC). The focus is on the subset of patients with BCG-unresponsive disease. In addition, the pathological diagnosis and staging, risk stratification, and trial design, including assessment of appropriate clinical endpoints, are discussed. The preferred trial design for demonstrating efficacy of drugs developed to treat NMIBC is a randomized, controlled trial with a time- to-event endpoint of recurrence-free survival. Single-arm trials are appropriate in clinical settings for which a randomized, controlled trial is either unethical or not feasible. Therefore, single-arm trials of patients with BCG-unresponsive carcinoma in situ with or without papillary disease using an endpoint of complete response rate (and duration) may be appropriate. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on developing drugs and biologics for the treatment of BCG-unresponsive NMIBC. 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. II. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 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: November 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-27762 Filed 11-17-16; 8:45 am] BILLING CODE 4164-01-P
![81778 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average bur-
Number of Total annual
Information collection activity responses per den per re- Total hours
respondents responses
respondent sponse
Notification for Carcinogenicity Protocols ............................ 29 1.8 53 8 424
Requests for Special Protocol Assessment ........................ 119 1.8 220 15 3,300
Total .............................................................................. ........................ ........................ ........................ ........................ 3,724
1 There are no capital costs or operating and maintenance costs associated with this collection.
Dated: November 15, 2016. Electronic Submissions those submitted as ‘‘Confidential
Leslie Kux, Submit electronic comments in the Submissions,’’ publicly viewable at
Associate Commissioner for Policy. following way: http://www.regulations.gov or at the
[FR Doc. 2016–27840 Filed 11–17–16; 8:45 am] • Federal eRulemaking Portal: http:// Division of Dockets Management
BILLING CODE 4164–01–P www.regulations.gov. Follow the between 9 a.m. and 4 p.m., Monday
instructions for submitting comments. through Friday.
Comments submitted electronically, • Confidential Submissions—To
DEPARTMENT OF HEALTH AND including attachments, to http:// submit a comment with confidential
HUMAN SERVICES www.regulations.gov will be posted to information that you do not wish to be
the docket unchanged. Because your made publicly available, submit your
Food and Drug Administration comment will be made public, you are comments only as a written/paper
solely responsible for ensuring that your submission. You should submit two
[Docket No. FDA–2016–D–3456] comment does not include any copies total. One copy will include the
confidential information that you or a information you claim to be confidential
Bacillus Calmette-Guerin— third party may not wish to be posted, with a heading or cover note that states
Unresponsive Nonmuscle Invasive such as medical information, your or ‘‘THIS DOCUMENT CONTAINS
Bladder Cancer: Developing Drugs and anyone else’s Social Security number, or CONFIDENTIAL INFORMATION.’’ The
Biologics for Treatment; Draft confidential business information, such Agency will review this copy, including
Guidance for Industry; Availability as a manufacturing process. Please note the claimed confidential information, in
that if you include your name, contact its consideration of comments. The
AGENCY: Food and Drug Administration, second copy, which will have the
HHS. information, or other information that
identifies you in the body of your claimed confidential information
ACTION: Notice of availability. comments, that information will be redacted/blacked out, will be available
posted on http://www.regulations.gov. for public viewing and posted on http://
SUMMARY: Summary: The Food and Drug • If you want to submit a comment www.regulations.gov. Submit both
Administration (FDA or Agency) is with confidential information that you copies to the Division of Dockets
announcing the availability of a draft do not wish to be made available to the Management. If you do not wish your
guidance for industry entitled ‘‘Bacillus public, submit the comment as a name and contact information to be
Calmette-Guerin (BCG)—Unresponsive written/paper submission and in the made publicly available, you can
Nonmuscle Invasive Bladder Cancer: manner detailed (see ‘‘Written/Paper provide this information on the cover
Developing Drugs and Biologics for Submissions’’ and ‘‘Instructions’’). sheet and not in the body of your
Treatment.’’ The purpose of this comments and you must identify this
guidance is to assist sponsors in the Written/Paper Submissions information as ‘‘confidential.’’ Any
development of drugs and biologics to Submit written/paper submissions as information marked as ‘‘confidential’’
treat patients with a high-risk form of follows: will not be disclosed except in
bladder cancer. The alternative is • Mail/Hand delivery/Courier (for accordance with 21 CFR 10.20 and other
radical cystectomy, a surgical procedure written/paper submissions): Division of applicable disclosure law. For more
with significant morbidity and Dockets Management (HFA–305), Food information about FDA’s posting of
mortality. This guidance will help and Drug Administration, 5630 Fishers comments to public dockets, see 80 FR
overcome some of the obstacles in Lane, Rm. 1061, Rockville, MD 20852. 56469, September 18, 2015, or access
conducting the studies needed to • For written/paper comments the information at: http://www.fda.gov/
establish efficacy of drugs and biologics submitted to the Division of Dockets regulatoryinformation/dockets/
for these patients with an unmet Management, FDA will post your default.htm.
medical need. comment, as well as any attachments, Docket: For access to the docket to
DATES: Although you can comment on except for information submitted, read background documents or the
any guidance at any time (see 21 CFR marked and identified, as confidential, electronic and written/paper comments
10.115(g)(5)), to ensure that the agency if submitted as detailed in received, go to http://
considers your comment on this draft ‘‘Instructions.’’ www.regulations.gov and insert the
Instructions: All submissions received docket number, found in brackets in the
mstockstill on DSK3G9T082PROD with NOTICES
guidance before it begins work on the
final version of the guidance, submit must include the Docket No. [ FDA– heading of this document, into the
either electronic or written comments 2016–D–3456] for ‘‘BCG-Unresponsive ‘‘Search’’ box and follow the prompts
on the draft guidance by February 16, Nonmuscle Invasive Bladder Cancer: and/or go to the Division of Dockets
2017. Developing Drugs and Biologics for Management, 5630 Fishers Lane, Rm.
Treatment; Draft Guidance for Industry; 1061, Rockville, MD 20852.
ADDRESSES: You may submit comments Availability.’’ Received comments will Submit written requests for single
as follows: be placed in the docket and, except for copies of the draft guidance to the
VerDate Sep<11>2014 20:21 Nov 17, 2016 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\18NON1.SGM 18NON1](https://thefederalregister.org/doc/81_FR_82001/page/1.svg)
![Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices 81779
Division of Drug Information, Center for the treatment of BCG-unresponsive make donor eligibility (DE)
Drug Evaluation and Research, Food NMIBC. It does not establish any rights determinations for donors of human
and Drug Administration, 10001 New for any person and is not binding on cells, tissues, and cellular and tissue-
Hampshire Ave., Hillandale Building, FDA or the public. You can use an based products (HCT/Ps) with
4th Floor, Silver Spring, MD 20993– alternative approach if it satisfies the information on infectious-disease risks
0002, or the Office of Communication, requirements of the applicable statutes related to receipt of FDA licensed
Outreach, and Development, Center for and regulations. human-derived clotting factor
Biologics Evaluation and Research, II. The Paperwork Reduction Act of concentrates (HDCFCs). The guidance
Food and Drug Administration, 10903 1995 explains that FDA no longer considers
New Hampshire Ave., Bldg. 71, Rm. FDA licensed HDCFCs as a risk factor
3128, Silver Spring, MD 20993–0002. This draft guidance refers to for human immunodeficiency virus
Send one self-addressed adhesive label previously approved collections of (HIV), Hepatitis B virus (HBV), or
to assist that office in processing your information found in FDA regulations. Hepatitis C virus (HCV). As such,
requests. See the SUPPLEMENTARY These collections of information are receipt of FDA licensed HDCFCs, or sex
INFORMATION section for electronic subject to review by the Office of with a person who has received FDA
access to the draft guidance document. Management and Budget (OMB) under licensed HDCFCs, should not be
the Paperwork Reduction Act of 1995 considered a risk factor when
FOR FURTHER INFORMATION CONTACT: V.
(44 U.S.C. 3501–3520). The collections determining eligibility of a donor of
Ellen Maher, Center for Drug Evaluation
of information in 21 CFR parts 312 and HCT/Ps. The guidance supplements the
and Research, Food and Drug
314 have been approved under OMB recommendations regarding HDCFCs
Administration, 10903 New Hampshire
control numbers 0910–0014 and 0910– that are contained in the guidance
Ave., Bldg. 22, Rm. 2352, Silver Spring,
0001, respectively. entitled ‘‘Eligibility Determination for
MD 20993–0002, 301–796–5017; or
Stephen Ripley, Center for Biologics III. Electronic Access Donors of Human Cells, Tissues, and
Evaluation and Research, Food and Cellular and Tissue-Based Products
Persons with access to the Internet
Drug Administration, 10903 New (HCT/Ps); Guidance for Industry’’ dated
may obtain the draft guidance at http://
Hampshire Ave., Bldg. 71, Rm. 7301, August 2007.
www.fda.gov/Drugs/Guidance
Silver Spring, MD 20993–0002, 240– ComplianceRegulatoryInformation/ DATES: The Agency is soliciting public
402–7911. Guidances/default.htm, http:// comment, but is implementing this
SUPPLEMENTARY INFORMATION: www.fda.gov/BiologicsBloodVaccines/ guidance immediately because the
GuidanceComplianceRegulatory Agency has determined that prior public
I. Background
Information/default.htm, or http:// participation is not appropriate. Submit
FDA is announcing the availability of www.regulations.gov. either electronic or written comments
a draft guidance for industry entitled on Agency guidances at any time.
Dated: November 14, 2016.
‘‘BCG-Unresponsive Nonmuscle
Leslie Kux, ADDRESSES: You may submit comments
Invasive Bladder Cancer: Developing
Associate Commissioner for Policy. as follows:
Drugs and Biologics for Treatment.’’
This draft guidance is intended to [FR Doc. 2016–27762 Filed 11–17–16; 8:45 am] Electronic Submissions
provide a framework for industry to BILLING CODE 4164–01–P
facilitate the development of drugs and Submit electronic comments in the
biologics to treat patients with following way:
nonmuscle invasive bladder cancer DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal: http://
(NMIBC). The focus is on the subset of HUMAN SERVICES www.regulations.gov. Follow the
patients with BCG-unresponsive instructions for submitting comments.
Food and Drug Administration Comments submitted electronically,
disease. In addition, the pathological
diagnosis and staging, risk stratification, [Docket No. FDA–2016–D–3750] including attachments, to http://
and trial design, including assessment www.regulations.gov will be posted to
of appropriate clinical endpoints, are Revised Recommendations for the docket unchanged. Because your
discussed. Determining Eligibility of Donors of comment will be made public, you are
The preferred trial design for Human Cells, Tissues, and Cellular and solely responsible for ensuring that your
demonstrating efficacy of drugs Tissue-Based Products Who Have comment does not include any
developed to treat NMIBC is a Received Human-Derived Clotting confidential information that you or a
randomized, controlled trial with a Factor Concentrates; Guidance for third party may not wish to be posted,
time-to-event endpoint of recurrence- Industry; Availability such as medical information, your or
free survival. Single-arm trials are AGENCY: Food and Drug Administration, anyone else’s Social Security number, or
appropriate in clinical settings for HHS. confidential business information, such
which a randomized, controlled trial is as a manufacturing process. Please note
ACTION: Notice of availability. that if you include your name, contact
either unethical or not feasible.
Therefore, single-arm trials of patients SUMMARY: The Food and Drug information, or other information that
with BCG-unresponsive carcinoma in Administration (FDA or Agency) is identifies you in the body of your
situ with or without papillary disease announcing the availability of a comments, that information will be
using an endpoint of complete response document entitled ‘‘Revised posted on http://www.regulations.gov.
mstockstill on DSK3G9T082PROD with NOTICES
rate (and duration) may be appropriate. Recommendations for Determining • If you want to submit a comment
This draft guidance is being issued Eligibility of Donors of Human Cells, with confidential information that you
consistent with FDA’s good guidance Tissues, and Cellular and Tissue-Based do not wish to be made available to the
practices regulation (21 CFR 10.115). Products Who Have Received Human- public, submit the comment as a
The draft guidance, when finalized, will Derived Clotting Factor Concentrates; written/paper submission and in the
represent the current thinking of FDA Guidance for Industry.’’ The guidance manner detailed (see ‘‘Written/Paper
on developing drugs and biologics for document provides establishments that Submissions’’ and ‘‘Instructions’’).
VerDate Sep<11>2014 20:21 Nov 17, 2016 Jkt 241001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\18NON1.SGM 18NON1](https://thefederalregister.org/doc/81_FR_82001/page/2.svg)
Document Created: 2018-02-14 08:32:16
Document Modified: 2018-02-14 08:32:16
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 16, 2017. | |
| 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 | 81 FR 81778 |
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