Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices 4933 

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. 

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 Form FDA 2830 Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

607.20(a), 607.21, 607.22, 607.25, 

and 607.40.

Initial Registration 68 1 68 1 ........................... 68 

607.21, 607.22, 607.25, 607.26, 

607.31, and 607.40.

Re-registration ...... 2,615 1 2,615 0.5 (30 minutes) ... 1,308 

607.21, 607.25, 607.30(a), 607.31, 

and 607.40.

Product Updating 

List.

166 1 166 0.25 (15 minutes) 42 

Total ............................................. .............................. ........................ ........................ ........................ .............................. 1,418 

1There are no capital costs of operating and maintenance costs associated with this collection of information 

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. 

Dated: January 26, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[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 

[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 http://

www.fda.gov/AboutFDA/Workingat

FDA/BuildingsandFacilities/WhiteOak

CampusInformation/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 

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4934 Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices 

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, firstserved basis. Persons interested in 

attending this workshop must register 

online at http://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 http://

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request Generic Clearance 

for the Collection of Qualitative 

Feedback on Agency Service Delivery 

(NIH) 

SUMMARY: 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 

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. 

Estimated Annualized Burden Hours 

ESTIMATED ANNUAL REPORTING BURDEN

Type of collection Number of 

espondents 

Annual 

frequency per 

esponse 

Hours per 

response 

Total annual 

burden hours 

Customer Satisfaction Surveys ....................................................................... 1,000 1 30/60 500 

In-Depth Interviews (IDIs) or Small Discussion Groups .................................. 1,000 1 90/60 1,500 

Focus Groups .................................................................................................. 1,000 1 90/60 1,500 

Usability and Pilot Testing ............................................................................... 150,000 1 5/60 12,525

Conference/Training—Pre and Post Surveys ................................................. 100,000 2 10/60 33,333 

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