Ulcerative Colitis: Clinical Trial Endpoints; Draft Guidance for Industry; Availability, 52449-52450 [2016-18716]

Download as PDF 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 VerDate Sep<11>2014 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
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