4932 Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices 

guidance details information on how the 

Agency intends to interpret and apply 

provisions of the existing regulations 

regarding internal Agency review of 

decisions. In addition, the guidance 

outlines the established procedures for 

persons who are sponsors, applicants or 

manufacturers, for animal drugs or other 

products regulated by CVM, that wish to 

submit a request for review of a 

scientific dispute. When a sponsor, 

applicant, or manufacturer has a 

scientific disagreement with a written 

decision by CVM, they may submit a 

request for a review of that decision by 

following the established Agency 

channels of supervision for review. 

In the Federal Register of November 

6, 2014 (79 FR 65976), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. One comment was received 

but it did not respond to any of the four 

collection of information topics 

solicited in the notice and therefore is 

not discussed in this document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

10.75 .................................................................................... 2 4 8 10 80 

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

CVM encourages applicants to begin 

the resolution of science-based disputes 

with discussions with the review team/ 

group, including the Team Leader or 

Division Director. The Center prefers 

that differences of opinion regarding 

science or science-based policy be 

resolved between the review team/group 

and the applicant. If the matter is not 

resolved by this preferred method, then 

CVM recommends that the applicant 

follow the procedure in guidance for 

industry #79. Of the two respondents 

who were advised on the procedure 

during the past 3 years, one has not 

followed up to initiate it and the other 

is working with the review team/group 

to resolve the issue(s). Therefore, this 

estimated annual reporting burden is 

based on CVM’s previous experience in 

handling formal appeals for scientific 

disputes. 

Dated: January 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01669 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–2014–N–1069] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Blood 

Establishment Registration and 

Product Listing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by March 2, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0052. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Blood Establishment Registration and 

Product Listing, Form FDA 2830—21 

CFR Part 607 (OMB Control Number 

0910–0052)—Extension 

Under section 510 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

360), any person owning or operating an 

establishment that manufactures, 

prepares, propagates, compounds, or 

processes a drug or device must register 

his or her name, place of business, and 

all such establishments with the 

Secretary of Health and Human Services 

on or before December 31 of each year. 

He or she must also submit, among 

other information, a listing of all drug or 

device products manufactured, 

prepared, propagated, compounded, or 

processed by him or her for commercial 

distribution. In part 607 (21 CFR part 

607), FDA has issued regulations 

implementing these requirements for 

manufacturers of human blood and 

blood products. 

Section 607.20(a), in brief, requires 

owners or operators of certain 

establishments that engage in the 

manufacture of blood products to 

register and to submit a list of every 

blood product in commercial 

distribution. 

Section 607.21, in brief, requires the 

owners or operators of establishments 

entering into the manufacturing of blood 

products to register within 5 days after 

beginning such operation and to submit 

a list of every blood product in 

commercial distribution at the time. If 

the owner or operator of the 

establishment has not previously 

entered into such operation for which a 

license is required, registration must 

follow within 5 days after the 

submission of a biologics license 

application. In addition, owners or 

operators of all establishments so 

engaged must register annually between 

November 15 and December 31 and 

update their blood product listing every 

June and December. 

Section 607.22 requires the use of 

Form FDA 2830, Blood Establishment 

Registration and Product Listing, for 

initial registration, for subsequent 

annual registration, and for blood 

product listing information. 

Section 607.25 sets forth the 

information required for establishment 

registration and blood product listing. 

Section 607.26, in brief, requires 

certain changes to be submitted on FDA 

Form 2830 as an amendment to 

mstockstill on DSK4VPTVN1PROD with NOTICES

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 

mstockstill on DSK4VPTVN1PROD with NOTICES