81 FR 52449 - Ulcerative Colitis: Clinical Trial Endpoints; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 152 (August 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 152 (August 8, 2016)
| Page Range | 52449-52450 | |
| FR Document | 2016-18716 |
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)] [Notices] [Pages 52449-52450] From the Federal Register Online [www.thefederalregister.org] [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HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-2319] Ulcerative Colitis: Clinical Trial Endpoints; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Ulcerative Colitis: Clinical Trial Endpoints.''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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 7, 2016.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: 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-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 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. [[Page 52450]] 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 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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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
![Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices 52449
impact. FDA encourages firms to submit DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
a presubmission to get feedback on their HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
data collection plan or contact the
Food and Drug Administration Written/Paper Submissions
appropriate review branch for
additional information if they are in the [Docket No. FDA–2016–D–2319]
Submit written/paper submissions as
process of developing a device in one of follows:
these categories. Ulcerative Colitis: Clinical Trial • Mail/Hand delivery/Courier (for
Endpoints; Draft Guidance for written/paper submissions): Division of
III. Paperwork Reduction Act of 1995
Industry; Availability Dockets Management (HFA–305), Food
This document refers to previously and Drug Administration, 5630 Fishers
approved collections of information AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
found in FDA regulations. These HHS. • For written/paper comments
collections of information are subject to ACTION: Notice of availability. submitted to the Division of Dockets
review by the Office of Management and Management, FDA will post your
Budget (OMB) under the Paperwork SUMMARY: The Food and Drug comment, as well as any attachments,
Reduction Act of 1995 (44 U.S.C. 3501– Administration (FDA or Agency) is except for information submitted,
3520). The collections of information in announcing the availability of a draft marked and identified, as confidential,
21 CFR part 814 have been approved guidance for industry entitled if submitted as detailed in
under OMB control number 0910–0231. ‘‘Ulcerative Colitis: Clinical Trial ‘‘Instructions.’’
Endpoints.’’ The purpose of this Instructions: All submissions received
IV. References guidance is to assist sponsors in the must include the Docket No. FDA–
The following references have been clinical development of drugs for the 2016–D–2319 for ‘‘Ulcerative Colitis:
placed on display in the Division of treatment of ulcerative colitis (UC) in Clinical Trial Endpoints; Draft Guidance
Dockets Management (see ADDRESSES) adult and pediatric patients. for Industry; Availability.’’ Received
and are available for viewing by Specifically, this guidance addresses comments will be placed in the docket
interested persons between 9 a.m. and 4 FDA’s current thinking regarding and, except for those submitted as
p.m., Monday through Friday; they are efficacy endpoints for UC clinical trials. ‘‘Confidential Submissions,’’ publicly
also available electronically at http:// DATES: Although you can comment on viewable at http://www.regulations.gov
www.regulations.gov. FDA has verified any guidance at any time (see 21 CFR or at the Division of Dockets
the Web site addresses, as of the date 10.115(g)(5)), to ensure that the Agency Management between 9 a.m. and 4 p.m.,
this document publishes in the Federal considers your comment on this draft Monday through Friday.
Register, but Web sites are subject to guidance before it begins work on the • Confidential Submissions—To
change over time. final version of the guidance, submit submit a comment with confidential
either electronic or written comments information that you do not wish to be
1. FDA, ‘‘CDRH 2014–2015 Strategic
Priorities,’’ 2014, http://www.fda.gov/
on the draft guidance by October 7, made publicly available, submit your
downloads/AboutFDA/CentersOffices/ 2016. comments only as a written/paper
OfficeofMedicalProductsandTobacco/ ADDRESSES: You may submit comments submission. You should submit two
CDRH/CDRHVisionandMission/ as follows: copies total. One copy will include the
UCM384576.pdf. information you claim to be confidential
2. ‘‘Guidance for Industry and FDA Staff: Electronic Submissions with a heading or cover note that states
Balancing Premarket and Postmarket
Data Collection for Devices Subject to Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Premarket Approval,’’ April 2015, http:// following way: CONFIDENTIAL INFORMATION.’’ The
www.fda.gov/ucm/groups/fdagov-public/ • Federal eRulemaking Portal: http:// Agency will review this copy, including
@fdagov-meddev-gen/documents/ www.regulations.gov. Follow the the claimed confidential information, in
document/ucm393994.pdf. instructions for submitting comments. its consideration of comments. The
3. ‘‘Guidance for Industry and FDA Staff: Comments submitted electronically, second copy, which will have the
Expedited Access for Premarket including attachments, to http:// claimed confidential information
Approval and De Novo Medical Devices www.regulations.gov will be posted to redacted/blacked out, will be available
Intended for Unmet Medical Need for the docket unchanged. Because your for public viewing and posted on http://
Life Threatening or Irreversibly
Debilitating Diseases or Conditions,’’
comment will be made public, you are www.regulations.gov. Submit both
April 2015, http://www.fda.gov/ucm/ solely responsible for ensuring that your copies to the Division of Dockets
groups/fdagov-public/@fdagov-meddev- comment does not include any Management. If you do not wish your
gen/documents/document/ confidential information that you or a name and contact information to be
ucm393978.pdf. third party may not wish to be posted, made publicly available, you can
4. ‘‘Second and final cohort of Results of the such as medical information, your or provide this information on the cover
2014–2015 Strategic Priority: Strike the anyone else’s Social Security number, or sheet and not in the body of your
Right Balance between Premarket and confidential business information, such comments and you must identify this
Postmarket Data Collection, ’’ available as a manufacturing process. Please note information as ‘‘confidential.’’ Any
at http://www.fda.gov/AboutFDA/
CentersOffices/
that if you include your name, contact information marked as ‘‘confidential’’
OfficeofMedicalProductsandTobacco/ information, or other information that will not be disclosed except in
identifies you in the body of your accordance with 21 CFR 10.20 and other
mstockstill on DSK3G9T082PROD with NOTICES
CDRH/CDRHVisionandMission/
default.htm. comments, that information will be applicable disclosure law. For more
posted on http://www.regulations.gov. information about FDA’s posting of
Dated: August 2, 2016. • If you want to submit a comment comments to public dockets, see 80 FR
Leslie Kux, with confidential information that you 56469, September 18, 2015, or access
Associate Commissioner for Policy. do not wish to be made available to the the information at: http://www.fda.gov/
[FR Doc. 2016–18672 Filed 8–5–16; 8:45 am] public, submit the comment as a regulatoryinformation/dockets/
BILLING CODE 4164–01–P written/paper submission and in the default.htm.
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![52450 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
Docket: For access to the docket to (among girls), and disease severity from the Office of Operations and
read background documents or the necessitating colectomy are more Management (RV2) and the
electronic and written/paper comments common in children. communications, grantee oversight and
received, go to http:// This draft guidance is being issued customer service functions from the
www.regulations.gov and insert the consistent with FDA’s good guidance Office of the Associate Administrator
docket number, found in brackets in the practices regulation (21 CFR 10.115). (RV) to the newly established Office of
heading of this document, into the The draft guidance, when finalized, will Program Support (RV3); and (3) updates
‘‘Search’’ box and follow the prompts represent the current thinking of FDA the functional statement for the Office of
and/or go to the Division of Dockets on clinical trial endpoints for UC. It Operations and Management (RV2), the
Management, 5630 Fishers Lane, Rm. does not establish any rights for any Division of Administrative Operations
1061, Rockville, MD 20852. person and is not binding on FDA or the (RV21), and the Office of the Associate
Submit written requests for single public. You can use an alternative Administrator (RV).
copies of the draft guidance to the approach if it satisfies the requirements
of the applicable statutes and Chapter RV—HIV/AIDS Bureau
Division of Drug Information, Center for
Drug Evaluation and Research, Food regulations. Section RV–10, Organization
and Drug Administration, 10001 New II. The Paperwork Reduction Act of Delete the organization for the Office
Hampshire Ave., Hillandale Building, 1995 of the Associate Administrator (RA) in
4th Floor, Silver Spring, MD 20993– its entirety and replace with the
0002. Send one self-addressed adhesive This draft guidance refers to
previously approved collections of following:
label to assist that office in processing The HIV/AIDS Bureau is headed by
your requests. See the SUPPLEMENTARY information that are subject to review by
the Office of Management and Budget the Associate Administrator, who
INFORMATION section for electronic
(OMB) under the Paperwork Reduction reports directly to the Administrator,
access to the draft guidance document. Health Resources and Services
FOR FURTHER INFORMATION CONTACT:
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR Administration.
Kevin Bugin, Center for Drug Evaluation (1) Office of the Associate
and Research, Food and Drug parts 312 and 314 have been approved
under OMB control numbers 0910–0014 Administrator (RV);
Administration, 10903 New Hampshire (2) Office of Operations and
Ave., Bldg. 22, Rm. 5232, Silver Spring, and 0910–0001, respectively.
Management (RV2);
MD 20993–0002, 301–796–2302. IV. Electronic Access a. Division of Administrative
SUPPLEMENTARY INFORMATION: Persons with access to the Internet Operations (RV21);
may obtain the draft guidance at either (3) Office of Program Support (RV3);
I. Background
http://www.fda.gov/Drugs/Guidance (4) Division of Policy and Data (RVA);
FDA is announcing the availability of ComplianceRegulatoryInformation/ (5) Division of Metropolitan HIV/
a draft guidance for industry entitled Guidances/default.htm or http:// AIDS Programs (RV5);
‘‘Ulcerative Colitis: Clinical Trial www.regulations.gov. (6) Division of State HIV/AIDS
Endpoints.’’ The purpose of this draft Programs (RVD);
guidance is to assist sponsors in the Dated: August 3, 2016.
(7) Division of Community HIV/AIDS
clinical development of drugs for the Leslie Kux, Programs (RV6); and
treatment of UC in adult and pediatric Associate Commissioner for Policy. (8) Office of HIV/AIDS Training and
patients. Specifically, this draft [FR Doc. 2016–18716 Filed 8–5–16; 8:45 am] Capacity Development (RVT);
guidance addresses FDA’s current BILLING CODE 4164–01–P a. Division of Domestic Programs; and
thinking regarding efficacy endpoints b. Division of Global Programs.
for UC clinical trials.
UC is a chronic, relapsing disease DEPARTMENT OF HEALTH AND Section RV–20, Functions
characterized by diffuse mucosal HUMAN SERVICES This notice reflects organizational
inflammation of the colon. UC involves changes in the Health Resources and
the rectum and it may extend Health Resources and Services Services Administration (HRSA), HIV/
proximally in a contiguous pattern to Administration AIDS Bureau (RV). Specifically, this
affect part of the colon or the entire notice: (1) Establishes the Office of
Statement of Organization, Functions
colon. Clinical manifestations of active Program Support; (RV3); (2) transfers
and Delegations of Authority
disease include bloody diarrhea (with or the organizational development,
without mucus), urgency, tenesmus, This notice amends Part R of the training and technological functions
abdominal pain, weight loss, fever, and Statement of Organization, Functions from the Office of Operations and
malaise. In patients with extensive or and Delegations of Authority of the Management (RV2) and the
severe inflammation, acute Department of Health and Human communications, grantee oversight and
complications such as severe bleeding Services (HHS), Health Resources and customer service functions from the
and toxic megacolon may occur. There Services Administration (HRSA) (60 FR Office of the Associate Administrator
is an increased risk of colorectal cancer 56605, as amended November 6, 1995; (RV) to the newly established Office of
in UC patients compared to the general as last amended at 81 FR 25680 dated Program Support (RV3); and (3) updates
population; risk factors include long April 29, 2016). the functional statement for the Office of
duration of disease, extensive colonic This notice reflects organizational Operations and Management (RV2), the
mstockstill on DSK3G9T082PROD with NOTICES
involvement, severe inflammation and changes in the Health Resources and Division of Administrative Operations
epithelial dysplasia, and childhood- Services Administration (HRSA), HIV/ (RV21), and the Office of the Associate
onset disease. The signs and symptoms AIDS Bureau (RV). Specifically, this Administrator (RV).
of UC in adults and children are similar; notice: (1) Establishes the Office of Delete the function for the following:
however, abdominal pain, disease Program Support; (RV3); (2) transfers (1) Office of the Associate Administrator
involving the entire colon, extra- the organizational development, (RV); (2) Office of Operations and
intestinal manifestations, proctitis training and technological functions Management (RV2); and the Division of
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Document Created: 2016-08-06 03:08:34
Document Modified: 2016-08-06 03:08:34
| 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 October 7, 2016. | |
| 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. | |
| FR Citation | 81 FR 52449 |
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