Ulcerative Colitis: Clinical Trial Endpoints; Draft Guidance for Industry; Availability, 52449-52450 [2016-18716]
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Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
impact. FDA encourages firms to submit
a presubmission to get feedback on their
data collection plan or contact the
appropriate review branch for
additional information if they are in the
process of developing a device in one of
these categories.
III. Paperwork Reduction Act of 1995
This document 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 part 814 have been approved
under OMB control number 0910–0231.
IV. References
mstockstill on DSK3G9T082PROD with NOTICES
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and are available for viewing by
interested persons between 9 a.m. and 4
p.m., Monday through Friday; they are
also available electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. FDA, ‘‘CDRH 2014–2015 Strategic
Priorities,’’ 2014, https://www.fda.gov/
downloads/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/
CDRH/CDRHVisionandMission/
UCM384576.pdf.
2. ‘‘Guidance for Industry and FDA Staff:
Balancing Premarket and Postmarket
Data Collection for Devices Subject to
Premarket Approval,’’ April 2015, https://
www.fda.gov/ucm/groups/fdagov-public/
@fdagov-meddev-gen/documents/
document/ucm393994.pdf.
3. ‘‘Guidance for Industry and FDA Staff:
Expedited Access for Premarket
Approval and De Novo Medical Devices
Intended for Unmet Medical Need for
Life Threatening or Irreversibly
Debilitating Diseases or Conditions,’’
April 2015, https://www.fda.gov/ucm/
groups/fdagov-public/@fdagov-meddevgen/documents/document/
ucm393978.pdf.
4. ‘‘Second and final cohort of Results of the
2014–2015 Strategic Priority: Strike the
Right Balance between Premarket and
Postmarket Data Collection, ’’ available
at https://www.fda.gov/AboutFDA/
CentersOffices/
OfficeofMedicalProductsandTobacco/
CDRH/CDRHVisionandMission/
default.htm.
Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18672 Filed 8–5–16; 8:45 am]
BILLING CODE 4164–01–P
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22:23 Aug 05, 2016
Jkt 238001
52449
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration
Written/Paper Submissions
[Docket No. FDA–2016–D–2319]
Ulcerative Colitis: Clinical Trial
Endpoints; 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
‘‘Ulcerative Colitis: Clinical Trial
Endpoints.’’ The purpose of this
guidance is to assist sponsors in the
clinical development of drugs for the
treatment of ulcerative colitis (UC) in
adult and pediatric patients.
Specifically, this guidance addresses
FDA’s current thinking regarding
efficacy endpoints for UC clinical trials.
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 October 7,
2016.
SUMMARY:
ADDRESSES:
You may submit comments
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
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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–2319 for ‘‘Ulcerative Colitis:
Clinical Trial Endpoints; Draft Guidance
for Industry; Availability.’’ 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 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 https://
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: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
E:\FR\FM\08AUN1.SGM
08AUN1
52450
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. 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:
Kevin Bugin, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5232, Silver Spring,
MD 20993–0002, 301–796–2302.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK3G9T082PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Ulcerative Colitis: Clinical Trial
Endpoints.’’ The purpose of this draft
guidance is to assist sponsors in the
clinical development of drugs for the
treatment of UC in adult and pediatric
patients. Specifically, this draft
guidance addresses FDA’s current
thinking regarding efficacy endpoints
for UC clinical trials.
UC is a chronic, relapsing disease
characterized by diffuse mucosal
inflammation of the colon. UC involves
the rectum and it may extend
proximally in a contiguous pattern to
affect part of the colon or the entire
colon. Clinical manifestations of active
disease include bloody diarrhea (with or
without mucus), urgency, tenesmus,
abdominal pain, weight loss, fever, and
malaise. In patients with extensive or
severe inflammation, acute
complications such as severe bleeding
and toxic megacolon may occur. There
is an increased risk of colorectal cancer
in UC patients compared to the general
population; risk factors include long
duration of disease, extensive colonic
involvement, severe inflammation and
epithelial dysplasia, and childhoodonset disease. The signs and symptoms
of UC in adults and children are similar;
however, abdominal pain, disease
involving the entire colon, extraintestinal manifestations, proctitis
VerDate Sep<11>2014
22:23 Aug 05, 2016
Jkt 238001
(among girls), and disease severity
necessitating colectomy are more
common in children.
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 clinical trial endpoints for UC. 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.
from the Office of Operations and
Management (RV2) and the
communications, grantee oversight and
customer service functions from the
Office of the Associate Administrator
(RV) to the newly established Office of
Program Support (RV3); and (3) updates
the functional statement for the Office of
Operations and Management (RV2), the
Division of Administrative Operations
(RV21), and the Office of the Associate
Administrator (RV).
II. The Paperwork Reduction Act of
1995
This draft 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.
Delete the organization for the Office
of the Associate Administrator (RA) in
its entirety and replace with the
following:
The HIV/AIDS Bureau is headed by
the Associate Administrator, who
reports directly to the Administrator,
Health Resources and Services
Administration.
(1) Office of the Associate
Administrator (RV);
(2) Office of Operations and
Management (RV2);
a. Division of Administrative
Operations (RV21);
(3) Office of Program Support (RV3);
(4) Division of Policy and Data (RVA);
(5) Division of Metropolitan HIV/
AIDS Programs (RV5);
(6) Division of State HIV/AIDS
Programs (RVD);
(7) Division of Community HIV/AIDS
Programs (RV6); and
(8) Office of HIV/AIDS Training and
Capacity Development (RVT);
a. Division of Domestic Programs; and
b. Division of Global Programs.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: August 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18716 Filed 8–5–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 81 FR 25680 dated
April 29, 2016).
This notice reflects organizational
changes in the Health Resources and
Services Administration (HRSA), HIV/
AIDS Bureau (RV). Specifically, this
notice: (1) Establishes the Office of
Program Support; (RV3); (2) transfers
the organizational development,
training and technological functions
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Chapter RV—HIV/AIDS Bureau
Section RV–10, Organization
Section RV–20, Functions
This notice reflects organizational
changes in the Health Resources and
Services Administration (HRSA), HIV/
AIDS Bureau (RV). Specifically, this
notice: (1) Establishes the Office of
Program Support; (RV3); (2) transfers
the organizational development,
training and technological functions
from the Office of Operations and
Management (RV2) and the
communications, grantee oversight and
customer service functions from the
Office of the Associate Administrator
(RV) to the newly established Office of
Program Support (RV3); and (3) updates
the functional statement for the Office of
Operations and Management (RV2), the
Division of Administrative Operations
(RV21), and the Office of the Associate
Administrator (RV).
Delete the function for the following:
(1) Office of the Associate Administrator
(RV); (2) Office of Operations and
Management (RV2); and the Division of
E:\FR\FM\08AUN1.SGM
08AUN1
Agencies
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52449-52450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18716]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2319]
Ulcerative Colitis: Clinical Trial Endpoints; 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 ``Ulcerative
Colitis: Clinical Trial Endpoints.'' The purpose of this guidance is to
assist sponsors in the clinical development of drugs for the treatment
of ulcerative colitis (UC) in adult and pediatric patients.
Specifically, this guidance addresses FDA's current thinking regarding
efficacy endpoints for UC clinical trials.
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 October 7, 2016.
ADDRESSES: You may submit comments 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): 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-2319 for ``Ulcerative Colitis: Clinical Trial Endpoints;
Draft Guidance for Industry; Availability.'' 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 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 https://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: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
[[Page 52450]]
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. 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: Kevin Bugin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5232, Silver Spring, MD 20993-0002, 301-
796-2302.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Ulcerative Colitis: Clinical Trial Endpoints.'' The purpose
of this draft guidance is to assist sponsors in the clinical
development of drugs for the treatment of UC in adult and pediatric
patients. Specifically, this draft guidance addresses FDA's current
thinking regarding efficacy endpoints for UC clinical trials.
UC is a chronic, relapsing disease characterized by diffuse mucosal
inflammation of the colon. UC involves the rectum and it may extend
proximally in a contiguous pattern to affect part of the colon or the
entire colon. Clinical manifestations of active disease include bloody
diarrhea (with or without mucus), urgency, tenesmus, abdominal pain,
weight loss, fever, and malaise. In patients with extensive or severe
inflammation, acute complications such as severe bleeding and toxic
megacolon may occur. There is an increased risk of colorectal cancer in
UC patients compared to the general population; risk factors include
long duration of disease, extensive colonic involvement, severe
inflammation and epithelial dysplasia, and childhood-onset disease. The
signs and symptoms of UC in adults and children are similar; however,
abdominal pain, disease involving the entire colon, extra-intestinal
manifestations, proctitis (among girls), and disease severity
necessitating colectomy are more common in children.
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 clinical trial
endpoints for UC. 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 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.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: August 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18716 Filed 8-5-16; 8:45 am]
BILLING CODE 4164-01-P