Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials; Draft Guidance for Industry; Availability, 56857-56859 [2018-24763]
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Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices
information are manufacturers of beers
that are subject to our labeling laws and
regulations.
In the Federal Register of June 29,
2018 (83 FR 30738), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Two comments were
received. One comment was unrelated
to the Paperwork Reduction Act and is
not addressed. The second comment
was in favor of the practical utility and
necessity of labeling the ingredients of
56857
beer for transparency to the consumer.
We are appreciative of these comments.
At this time, we do not plan on
adjusting our current estimate.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
disclosures
per
respondent
Number of
respondents
21 CFR section; activity
Average
burden per
disclosure
Total annual
disclosures
Total
hours
§§ 101.3 and 101.22; principal display and display
panel.
§ 101.4; designation of ingredients ........................
§ 101.5; name of manufacturer; packer; distributor
§ 101.9; nutrition labeling .......................................
§ 101.7 (formerly 101.105); quantity of contents ...
Section 403(w)(1) of the FD&C Act .......................
Review of Guidance Document: ‘‘Labeling of Certain Beers Subject to the Labeling Jurisdiction
of the Food and Drug Administration’’.
12
2
24
0.5 (30 minutes) ..........
12
12
12
12
12
12
12
2
2
2
2
2
1
24
24
24
24
24
12
1 ..................................
0.25 (15 minutes) ........
4 ..................................
0.5 (30 minutes) ..........
1 ..................................
1 ..................................
24
6
96
12
24
12
Total ................................................................
........................
........................
........................
.....................................
186
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. Our
estimate of the number of respondents
is based on the number of regulatory
submissions to TTB for beers that do not
meet the definition of a ‘‘malt beverage’’
under the FAA Act. Based on its records
of submissions received from
manufacturers of such products, TTB
estimates the annual number of
respondents to be 12 and the annual
number of disclosures to be 24. Thus,
we adopt TTB’s estimate of 12 annual
respondents, and an annual number of
disclosures per respondent of 2 in table
1.
Our estimates of the average burden
per disclosure for each collection
provision are based on our experience
with food labeling under the Agency’s
jurisdiction. The estimated average
burden per disclosure for §§ 101.3,
101.4, 101.5, 101.9, 101.22, and 101.105
in table 1 are equal to, and based upon,
the estimated average burden per
disclosure approved by OMB in OMB
control number 0910–0381. We further
estimate that the labeling burden of
section 403(w)(1) of the FD&C Act,
which specifies requirements for the
declaration of food allergens, will be 1
hour based upon the similarity of the
requirements to that of § 101.4. Finally,
FDA estimates that a respondent will
spend 1 hour reading the guidance.
Thus, we estimate that 12 respondents
will each label 2 products annually, for
a total of 24 labels. We estimate that the
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18:29 Nov 13, 2018
Jkt 247001
manufacturers will spend 7.25 hours
(0.5 hours + 1 hour + 0.25 hour + 4
hours + 0.5 hour + 1 hour = 7.25 hours)
on each label to comply with our
labeling regulations and the
requirements of section 403(w)(1) of the
FD&C Act, for a total of 174 hours (24
labels × 7.25 hours = 174 hours). In
addition, 12 respondents will each
spend 1 hour reading the guidance
document, for a total of 12 hours. Thus,
we estimate the total hour burden of the
proposed collection of information to be
186 hours (174 hours + 12 hours = 186
hours).
The guidance also refers to previously
approved collections of information
found in our regulations. The
collections of information in §§ 101.3,
101.4, 101.5, 101.9, 101.22, and 101.105
have been approved under OMB control
number 0910–0381. Allergen labeling of
these beers under section 403(w)(1) of
the FD&C Act, which was added by the
Food Allergen Labeling and Consumer
Protection Act of 2004, has been
approved under OMB control number
0910–0792.
Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24786 Filed 11–13–18; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3931]
Nonmetastatic, Castration-Resistant
Prostate Cancer: Considerations for
Metastasis-Free Survival Endpoint in
Clinical Trials; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Nonmetastatic, Castration-Resistant
Prostate Cancer: Considerations for
Metastasis-Free Survival Endpoint in
Clinical Trials.’’ This draft guidance
provides recommendations to sponsors
regarding the use of metastasis-free
survival (MFS) as an endpoint in
clinical trials for nonmetastatic,
castration-resistant prostate cancer
(nmCRPC) development programs for
drug or biological products regulated by
the Center for Drug Evaluation and
Research (CDER) and the Center for
Biologics Evaluation and Research
(CBER).
DATES: Submit either electronic or
written comments on the draft guidance
by January 14, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
SUMMARY:
E:\FR\FM\14NON1.SGM
14NON1
56858
Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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–3931 for ‘‘Nonmetastatic,
Castration-Resistant Prostate Cancer:
Considerations for Metastasis-Free
Survival Endpoint in Clinical Trials.’’
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
VerDate Sep<11>2014
18:29 Nov 13, 2018
Jkt 247001
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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 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 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: Julia
Beaver, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2100, Silver Spring,
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
MD 20993–0002, 240–402–0489; 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
‘‘Nonmetastatic, Castration-Resistant
Prostate Cancer: Considerations for
Metastasis-Free Survival Endpoint in
Clinical Trials.’’ This draft guidance
provides recommendations to sponsors
regarding the use of MFS as an endpoint
in clinical trials for nmCRPC
development programs for drug or
biological products regulated by CDER
and CBER.
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 ‘‘Nonmetastatic, Castration-Resistant
Prostate Cancer: Considerations for
Metastasis-Free Survival Endpoint in
Clinical Trials.’’ 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. 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 collection of
information in 21 CFR part 312 has been
approved under OMB control number
0910–0014. The collections of
information in 21 CFR parts 50 and 56
(Protection of Human Subjects:
Informed Consent; Institutional Review
Boards) have been approved under OMB
control number 0910–0755.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
E:\FR\FM\14NON1.SGM
14NON1
Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices
Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24763 Filed 11–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[OMHA–1802–N]
Medicare Program; Administrative Law
Judge Hearing Program for Medicare
Claim and Entitlement Appeals;
Quarterly Listing of Program
Issuances—July Through September
2018
Office of Medicare Hearings
and Appeals (OMHA), HHS.
ACTION: Notice.
AGENCY:
This quarterly notice lists the
OMHA Case Processing Manual (OCPM)
instructions that were published from
July through September 2018. This
manual standardizes the day-to-day
procedures for carrying out adjudicative
functions, in accordance with
applicable statutes, regulations, and
OMHA directives, and gives OMHA
staff direction for processing appeals at
the OMHA level of adjudication.
FOR FURTHER INFORMATION CONTACT:
Jason Green, by telephone at (571) 777–
2723, or by email at jason.green@
hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Background
The Office of Medicare Hearings and
Appeals (OMHA), a staff division within
the Office of the Secretary within the
U.S. Department of Health and Human
Services (HHS), administers the
nationwide Administrative Law Judge
hearing program for Medicare claim;
organization, coverage, and at-risk
determination; and entitlement appeals
under sections 1869, 1155,
1876(c)(5)(B), 1852(g)(5), and 1860D–
4(h) of the Social Security Act (the Act).
OMHA ensures that Medicare
beneficiaries and the providers and
suppliers that furnish items or services
to Medicare beneficiaries, as well as
Medicare Advantage organizations
(MAOs), Medicaid State agencies, and
applicable plans, have a fair and
impartial forum to address
disagreements with Medicare coverage
and payment determinations made by
Medicare contractors, MAOs, or Part D
plan sponsors (PDPSs), and
determinations related to Medicare
eligibility and entitlement, Part B late
enrollment penalty, and income-related
monthly adjustment amounts (IRMAA)
VerDate Sep<11>2014
18:29 Nov 13, 2018
Jkt 247001
made by the Social Security
Administration (SSA).
The Medicare claim, organization
determination, coverage determination,
and at-risk determination appeals
processes consist of four levels of
administrative review, and a fifth level
of review with the Federal district
courts after administrative remedies
under HHS regulations have been
exhausted. The first two levels of review
are administered by the Centers for
Medicare & Medicaid Services (CMS)
and conducted by Medicare contractors
for claim appeals, by MAOs and an
independent review entity for Part C
organization determination appeals, or
by PDPSs and an independent review
entity for Part D coverage determination
and at-risk determination appeals. The
third level of review is administered by
OMHA and conducted by
Administrative Law Judges and attorney
adjudicators. The fourth level of review
is administered by the HHS
Departmental Appeals Board (DAB) and
conducted by the Medicare Appeals
Council (Council). In addition, OMHA
and the DAB administer the second and
third levels of appeal, respectively, for
Medicare eligibility, entitlement, Part B
late enrollment penalty, and IRMAA
reconsiderations made by SSA; a fourth
level of review with the Federal district
courts is available after administrative
remedies within SSA and HHS have
been exhausted.
Sections 1869, 1155, 1876(c)(5)(B),
1852(g)(5), and 1860D–4(h) of the Act
are implemented through the
regulations at 42 CFR part 405 subparts
I and J; part 417, subpart Q; part 422,
subpart M; part 423, subparts M and U;
and part 478, subpart B. As noted above,
OMHA administers the nationwide
Administrative Law Judge hearing
program in accordance with these
statutes and applicable regulations. To
help ensure nationwide consistency in
that effort, OMHA established a manual,
the OCPM. Through the OCPM, the
OMHA Chief Administrative Law Judge
establishes the day-to-day procedures
for carrying out adjudicative functions,
in accordance with applicable statutes,
regulations, and OMHA directives. The
OCPM provides direction for processing
appeals at the OMHA level of
adjudication for Medicare Part A and B
claims; Part C organization
determinations; Part D coverage
determinations and at-risk
determinations; and SSA eligibility and
entitlement, Part B late enrollment
penalty, and IRMAA determinations.
Section 1871(c) of the Act requires
that the Secretary publish a list of all
Medicare manual instructions,
interpretive rules, statements of policy,
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Fmt 4703
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56859
and guidelines of general applicability
not issued as regulations at least every
three months in the Federal Register.
II. Format for the Quarterly Issuance
Notices
This quarterly notice provides the
specific updates to the OCPM that have
occurred in the three-month period of
July through September 2018. A
hyperlink to the available chapters on
the OMHA website is provided below.
The OMHA website contains the most
current, up-to-date chapters and
revisions to chapters, and will be
available earlier than we publish our
quarterly notice. We believe the OMHA
website provides more timely access to
the current OCPM chapters for those
involved in the Medicare claim;
organization, coverage, and at-risk
determination; and entitlement appeals
processes. We also believe the website
offers the public a more convenient tool
for real time access to current OCPM
provisions. In addition, OMHA has a
listserv to which the public can
subscribe to receive notification of
certain updates to the OMHA website,
including when new or revised OCPM
chapters are posted. If accessing the
OMHA website proves to be difficult,
the contact person listed above can
provide the information.
III. How To Use the Notice
This notice lists the OCPM chapters
and subjects published during the
quarter covered by the notice so the
reader may determine whether any are
of particular interest. We expect this
notice to be used in concert with future
published notices. The OCPM can be
accessed at https://www.hhs.gov/about/
agencies/omha/the-appeals-process/
case-processing-manual/.
IV. OCPM Releases for July Through
September 2018
The OCPM is used by OMHA
adjudicators and staff to administer the
OMHA program. It offers day-to-day
operating instructions, policies, and
procedures based on statutes and
regulations, and OMHA directives.
The following is a list and description
of OCPM provisions that were revised in
the three-month period of July through
September 2018. This information is
available on our website at https://
www.hhs.gov/about/agencies/omha/theappeals-process/case-processingmanual/.
OCPM Chapter 5: Representatives
Chapter 5, Representatives. This
chapter describes the role of
representatives in the appeals process,
including the documentation required
E:\FR\FM\14NON1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Notices]
[Pages 56857-56859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24763]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-3931]
Nonmetastatic, Castration-Resistant Prostate Cancer:
Considerations for Metastasis-Free Survival Endpoint in Clinical
Trials; Draft 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 draft guidance for industry entitled
``Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations
for Metastasis-Free Survival Endpoint in Clinical Trials.'' This draft
guidance provides recommendations to sponsors regarding the use of
metastasis-free survival (MFS) as an endpoint in clinical trials for
nonmetastatic, castration-resistant prostate cancer (nmCRPC)
development programs for drug or biological products regulated by the
Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER).
DATES: Submit either electronic or written comments on the draft
guidance by January 14, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
[[Page 56858]]
ADDRESSES: You may submit comments on any guidance 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-3931 for ``Nonmetastatic, Castration-Resistant Prostate
Cancer: Considerations for Metastasis-Free Survival Endpoint in
Clinical Trials.'' 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.gpo.gov/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 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 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: Julia Beaver, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993-0002, 240-
402-0489; 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 ``Nonmetastatic, Castration-Resistant Prostate Cancer:
Considerations for Metastasis-Free Survival Endpoint in Clinical
Trials.'' This draft guidance provides recommendations to sponsors
regarding the use of MFS as an endpoint in clinical trials for nmCRPC
development programs for drug or biological products regulated by CDER
and CBER.
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
``Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations
for Metastasis-Free Survival Endpoint in Clinical Trials.'' 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. 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
collection of information in 21 CFR part 312 has been approved under
OMB control number 0910-0014. The collections of information in 21 CFR
parts 50 and 56 (Protection of Human Subjects: Informed Consent;
Institutional Review Boards) have been approved under OMB control
number 0910-0755.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.
[[Page 56859]]
Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24763 Filed 11-13-18; 8:45 am]
BILLING CODE 4164-01-P
