5468 Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices 

Workshop objectives will include 

discussion and identification of 

promising innovations that could 

facilitate successful trials in OA, new 

approaches to recruitment for clinical 

trials, feasible and clinically meaningful 

trial endpoints, and approaches for 

reducing the time and cost of OA trials 

while maximizing the likelihood of 

success. 

Registration: There is no fee to attend 

the workshop, but attendees must 

register in advance. Space is very 

limited. Persons interested in attending 

this workshop may request to register by 

sending their resume and inquiry to 

AFScience@arthritis.org. The 

registration deadline is February 2, 

2016. 

II. Accommodations 

An online registration link and a 

meeting code will be provided through 

the registration process giving 

participants a reduced group rate for 

hotel accomodations, not including 

applicable taxes. No additional 

reservations are required. Industry and 

government attendees are responsible 

for the cost of their own accomodations. 

If you need special accommodations 

due to a disability, please contact Becky 

Bosworth at bbosworth@arthritis.org at 

least 7 days in advance. 

III. Transcripts 

No transcripts will be available from 

the event, however, the event will be 

video taped for the purposes of the 

Arthritis Foundation. Speaker 

presentation materials, if permitted by 

the presenter, will be available on the 

Arthritis Foundation Web site following 

the workshop. 

Dated: January 27, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01789 Filed 2–1–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0145] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Improving Food Safety and Defense 

Capacity of the State and Local Level: 

Review of State and Local Capacities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Improving Food Safety and Defense 

Capacity of the State and Local Level: 

Review of State and Local Capacities’’ 

has been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

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: On 

November 30, 2015, the Agency 

submitted a proposed collection of 

information entitled ‘‘Improving Food 

Safety and Defense Capacity of the State 

and Local Level: Review of State and 

Local Capacities’’ to OMB for review 

and clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0726. The 

approval expires on January 31, 2019. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: January 27, 2016. 

Leslie Kux, 

Associate Commissioner for Policy 

[FR Doc. 2016–01785 Filed 2–1–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–0275] 

Regulatory Site Visit Training Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA’s) Center for 

Biologics Evaluation and Research 

(CBER) is announcing an invitation for 

participation in its Regulatory Site Visit 

Training Program (RSVP). This training 

program is intended to give CBER 

regulatory review, compliance, and 

other relevant staff an opportunity to 

visit biologics facilities. These visits are 

intended to allow CBER staff to directly 

observe routine manufacturing practices 

and to give CBER staff a better 

understanding of the biologics industry, 

including its challenges and operations. 

The purpose of this document is to 

invite biologics facilities to contact 

CBER for more information if they are 

interested in participating in this 

program. 

DATES: Submit either an electronic or 

written request for participation in this 

program by March 3, 2016. The request 

should include a description of your 

facility relative to products regulated by 

CBER. Please specify the physical 

address(es) of the site(s) you are 

offering. 

ADDRESSES: If your biologics facility is 

interested in offering a site visit, submit 

either an electronic request to http://

www.regulations.gov or a written 

request to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. If you 

previously responded to earlier requests 

to participate in this program and you 

continue to be interested in 

participating, please renew your request 

through a submission to the Division of 

Dockets Management. 

FOR FURTHER INFORMATION CONTACT: 

Cynthia Whitmarsh, Division of 

Manufacturers Assistance and Training, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. G112, Silver Spring, 

MD 20993–0002, 240–402–8010, FAX: 

301–595–1243, email: 

Industry.Biologics@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CBER regulates certain biological 

products including blood and blood 

products, vaccines, and cellular, tissue, 

and gene therapies. CBER is committed 

to advancing the public health through 

innovative activities that help ensure 

the safety, effectiveness, and availability 

of biological products to patients. To 

support this primary goal, CBER has 

initiated various training and 

development programs, including 

programs to further enhance 

performance of its compliance staff, 

regulatory review staff, and other 

relevant staff. CBER seeks to 

continuously enhance and update 

review efficiency and quality, and the 

quality of its regulatory efforts and 

interactions, by providing CBER staff 

with a better understanding of the 

biologics industry and its operations. 

Further, CBER seeks to enhance: (1) Its 

understanding of current industry 

practices and regulatory impacts and 

needs and (2) communication between 

CBER staff and industry. CBER initiated 

its RSVP in 2005. Through these annual 


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Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices 5469 

notices, CBER is requesting that those 

firms that have previously applied and 

are still interested in participating 

reaffirm their interest. CBER is also 

requesting that new interested parties 

apply. 

II. RSVP 

A. Regulatory Site Visits 

In this program, over a period of time 

to be agreed upon with the facility, 

small groups of CBER staff may observe 

operations of biologics establishments, 

including for example, blood and tissue 

establishments. The visits may include 

the following: (1) Packaging facilities, 

(2) quality control and pathology/

toxicology laboratories, and (3) 

regulatory affairs operations. These 

visits, or any part of the program, are 

not intended as a mechanism to inspect, 

assess, judge, or perform a regulatory 

function, but are meant to improve 

mutual understanding and to provide an 

avenue for open dialogue between the 

biologics industry and CBER. 

B. Site Selection 

CBER will be responsible for all travel 

expenses associated with the site visits. 

Therefore, selection of potential 

facilities will be based on the 

coordination of CBER’s priorities for 

staff training as well as the limited 

available resources for this program. In 

addition to logistical and other resource 

factors to consider, a key element of site 

selection is a successful compliance 

record with FDA or another Agency 

with which we have a memorandum of 

understanding. If a site visit involves a 

visit to a separate physical location of 

another firm under contract to the 

applicant, the other firm also needs to 

agree to participate in the program, as 

well as have a satisfactory compliance 

history. If you are a firm with multiple 

sites, please submit no more than three 

specific locations for consideration. 

III. Requests for Participation 

Identify requests for participation 

with the docket number found in 

brackets in the heading of this 

document. Received requests are 

available for public examination in the 

Division of Dockets Management (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: January 27, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01780 Filed 2–1–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0908] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance for Clinical Trial Sponsors: 

Establishment and Operation of 

Clinical Trial Data Monitoring 

Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance for Clinical Trial Sponsors: 

Establishment and Operation of Clinical 

Trial Data Monitoring Committees’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

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: On 

September 22, 2015, the Agency 

submitted a proposed collection of 

information entitled ‘‘Guidance for 

Clinical Trial Sponsors: Establishment 

and Operation of Clinical Trial Data 

Monitoring Committees’’ to OMB for 

review and clearance under 44 U.S.C. 

3507. An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. OMB has now 

approved the information collection and 

has assigned OMB control number 

0910–0581. The approval expires on 

December 31, 2018. A copy of the 

supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: January 27, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01781 Filed 2–1–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0609] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance for Industry on Drug Supply 

Chain Security Act Implementation: 

Identification of Suspect Product and 

Notification 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance for Industry on Drug Supply 

Chain Security Act Implementation: 

Identification of Suspect Product and 

Notification’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

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: On 

September 21, 2015, the Agency 

submitted a proposed collection of 

information entitled ‘‘Guidance for 

Industry on Drug Supply Chain Security 

Act Implementation: Identification of 

Suspect Product and Notification’’ to 

OMB for review and clearance under 44 

U.S.C. 3507. An Agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0806. The 

approval expires on December 31, 2018. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http://

www.reginfo.gov/public/do/PRAMain. 

Dated: January 27, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01784 Filed 2–1–16; 8:45 am] 

BILLING CODE 4164–01–P 


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