Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop, 4933-4934 [2015-01625]

Download as PDF Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices establishment registration within 5 days of such changes. Section 607.30(a), in brief, sets forth the information required from owners or operators of establishments when updating their blood product listing information every June and December, or at the discretion of the registrant at the time the change occurs. Section 607.31 requires that additional blood product listing information be provided upon FDA request. Section 607.40, in brief, requires certain foreign blood product establishments to comply with the establishment registration and blood product listing information requirements discussed earlier in this document and to provide the name and address of the establishment and the name of the individual responsible for submitting the establishment registration and blood product listing information, as well as the name, address, and phone number of its U.S. agent. Among other uses, this information assists FDA in its inspections of facilities and is essential to the overall regulatory scheme designed to ensure the safety of the Nation’s blood supply. Form FDA 2830 is used to collect this information. 4933 Respondents to this collection of information are human blood and plasma donor centers, blood banks, certain transfusion services, other blood product manufacturers, and independent laboratories that engage in quality control and testing for registered blood product establishments. In the Federal Register of August 11, 2014 (79 FR 46838), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received no comments. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR section 607.20(a), 607.21, 607.22, 607.25, and 607.40. 607.21, 607.22, 607.25, 607.26, 607.31, and 607.40. 607.21, 607.25, 607.30(a), 607.31, and 607.40. Total ............................................. Initial Registration 1 There Average burden per response Total hours 68 1 ........................... 68 Re-registration ...... 2,615 1 2,615 0.5 (30 minutes) ... 1,308 Product Updating List. .............................. 166 1 166 ........................ ........................ ........................ 0.25 (15 minutes) .............................. 42 1,418 are no capital costs of operating and maintenance costs associated with this collection of information [FR Doc. 2015–01670 Filed 1–28–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration The public workshop will be held on March 30 and 31, 2015, from 8:30 a.m. to 5 p.m. Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop Food and Drug Administration, Notice of public workshop. The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn’s and Colitis Foundation of America, Inc., the North VerDate Sep<11>2014 18:16 Jan 28, 2015 Jkt 235001 The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/Workingat FDA/BuildingsandFacilities/WhiteOak CampusInformation/ucm241740.htm. ADDRESSES: HHS. SUMMARY: American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, the North American Society for the Study of Celiac Disease, and the Pediatric Inflammatory Bowel Disease Foundation, is announcing a 2-day public workshop entitled ‘‘Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT III).’’ The purpose of this workshop is to provide a forum to consider issues related to selection of endpoints and clinical outcome measures appropriate for drug development in the following disease areas: Inflammatory bowel diseases and celiac disease. DATES: [Docket No. FDA–2015–N–0001] ACTION: Total annual responses 1 Dated: January 26, 2015. Leslie Kux, Associate Commissioner for Policy. AGENCY: Number of responses per respondent 68 FDA estimates the burden of this collection of information based upon information obtained from FDA’s Center for Biologics Evaluation and Research’s database and FDA experience with the blood establishment registration and product listing requirements. mstockstill on DSK4VPTVN1PROD with NOTICES Number of respondents Form FDA 2830 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Kelly Richards, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Rm. 5237, Silver Spring, MD 20993–0002, 240–402–4276, FAX: 301–796–9904, email: GREAT@ fda.hhs.gov. This workshop will address endpoints for registration trials in inflammatory bowel diseases and celiac disease. Stakeholders, including industry sponsors, academia, patients and FDA, will address challenging issues related to selection of endpoints and assessment methodologies in clinical trials intended to support approval of products for treatment of inflammatory bowel diseases and celiac disease. The first day of the workshop will discuss the assessment of efficacy in Crohn’s disease trials, including the use of patient-reported outcome measures and endoscopic evaluation, as well as the role of registries and patient participation in inflammatory bowel disease drug development programs. The second day of the workshop will discuss the appropriate target population for pharmacological therapy in celiac disease, and the definition and measurement of a treatment benefit in celiac disease registration trials, including the role and timing of SUPPLEMENTARY INFORMATION: E:\FR\FM\29JAN1.SGM 29JAN1 4934 Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices assessment of histological and serological endpoints. I. Participation in the Public Workshop National Institutes of Health There is no fee to attend the public workshop, but attendees must register in advance. Space is limited and registration will be on a first-come, firstserved basis. Persons interested in attending this workshop must register online at https://www.great3.org before March 1, 2015. For those without Internet access, please contact Kelly Richards (see FOR FURTHER INFORMATION CONTACT) to register. Onsite registration will not be available. If you need special accommodations due to a disability, please contact Kelly Richards (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance. comments in writing, or request more information on the proposed project, contact: Ms. Mikia P. Currie, Program Analyst, Office of Policy for Extramural Research Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland 20892, or call a non-toll-free number 301–435–0941 or Email your request, including your address to curriem@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIH), 0925–0648, Expiration Date 1/31/2015, EXTENSION, National Institutes of Health (NIH), Office of the Director (OD). Need and Use of Information Collection: There are no changes being requested for this submission. The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration’s commitment to improving service delivery. This generic will provide information about the NIH Institutes and Centers customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training, or changes in operations might improve delivery of products or services. It will also allow feedback to contribute directly to the improvement of program management. Feedback collected under this generic clearance will provide useful information but it will not yield data that can be generalized to the overall population. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated burden hours are 49,358. DEPARTMENT OF HEALTH AND HUMAN SERVICES Submission for OMB Review; 30-Day Comment Request Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIH) II. Transcripts Transcripts of the workshop will be available for review at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and on the Internet at https:// www.regulations.gov approximately 30 days after the workshop. A transcript will also be available in either hard copy or on CD–ROM after submission of a Freedom of Information request. Send written requests to the Division of Freedom of Information (ELEM–1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Fax requests to 301–827– 9267. Dated: January 22, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–01625 Filed 1–28–15; 8:45 am] BILLING CODE 4164–01–P Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on November 21, 2014, volume #79, page 69500 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@ omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, submit SUMMARY: Estimated Annualized Burden Hours ESTIMATED ANNUAL REPORTING BURDEN Number of espondents mstockstill on DSK4VPTVN1PROD with NOTICES Type of collection Customer Satisfaction Surveys ....................................................................... In-Depth Interviews (IDIs) or Small Discussion Groups .................................. Focus Groups .................................................................................................. Usability and Pilot Testing ............................................................................... Conference/Training—Pre and Post Surveys ................................................. VerDate Sep<11>2014 18:16 Jan 28, 2015 Jkt 235001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 Annual frequency per esponse 1,000 1,000 1,000 150,000 100,000 E:\FR\FM\29JAN1.SGM 1 1 1 1 2 29JAN1 Hours per response 30/60 90/60 90/60 5/60 10/60 Total annual burden hours 500 1,500 1,500 12,525 33,333

Agencies

[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Notices]
[Pages 4933-4934]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01625]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Gastroenterology Regulatory Endpoints and the Advancement of 
Therapeutics; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration's (FDA) Center for Drug 
Evaluation and Research, in cosponsorship with the American College of 
Gastroenterology, the American Gastroenterological Association, the 
Crohn's and Colitis Foundation of America, Inc., the North American 
Society for Pediatric Gastroenterology, Hepatology, and Nutrition, the 
North American Society for the Study of Celiac Disease, and the 
Pediatric Inflammatory Bowel Disease Foundation, is announcing a 2-day 
public workshop entitled ``Gastroenterology Regulatory Endpoints and 
the Advancement of Therapeutics (GREAT III).'' The purpose of this 
workshop is to provide a forum to consider issues related to selection 
of endpoints and clinical outcome measures appropriate for drug 
development in the following disease areas: Inflammatory bowel diseases 
and celiac disease.

DATES: The public workshop will be held on March 30 and 31, 2015, from 
8:30 a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the 
Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public 
workshop participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Kelly Richards, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Rm. 5237, Silver Spring, MD 20993-0002, 240-402-4276, 
FAX: 301-796-9904, email: GREAT@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: This workshop will address endpoints for 
registration trials in inflammatory bowel diseases and celiac disease. 
Stakeholders, including industry sponsors, academia, patients and FDA, 
will address challenging issues related to selection of endpoints and 
assessment methodologies in clinical trials intended to support 
approval of products for treatment of inflammatory bowel diseases and 
celiac disease. The first day of the workshop will discuss the 
assessment of efficacy in Crohn's disease trials, including the use of 
patient-reported outcome measures and endoscopic evaluation, as well as 
the role of registries and patient participation in inflammatory bowel 
disease drug development programs. The second day of the workshop will 
discuss the appropriate target population for pharmacological therapy 
in celiac disease, and the definition and measurement of a treatment 
benefit in celiac disease registration trials, including the role and 
timing of

[[Page 4934]]

assessment of histological and serological endpoints.

I. Participation in the Public Workshop

    There is no fee to attend the public workshop, but attendees must 
register in advance. Space is limited and registration will be on a 
first-come, first-served basis. Persons interested in attending this 
workshop must register online at https://www.great3.org before March 1, 
2015. For those without Internet access, please contact Kelly Richards 
(see FOR FURTHER INFORMATION CONTACT) to register. Onsite registration 
will not be available.
    If you need special accommodations due to a disability, please 
contact Kelly Richards (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance.

II. Transcripts

    Transcripts of the workshop will be available for review at the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and on the Internet 
at https://www.regulations.gov approximately 30 days after the workshop. 
A transcript will also be available in either hard copy or on CD-ROM 
after submission of a Freedom of Information request. Send written 
requests to the Division of Freedom of Information (ELEM-1029), Food 
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, 
MD 20857. Fax requests to 301-827-9267.

    Dated: January 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01625 Filed 1-28-15; 8:45 am]
BILLING CODE 4164-01-P

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