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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