81 FR 5469 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 21 (February 2, 2016)

Page Range		5469-5469
FR Document		2016-01784

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.

Federal Register, Volume 81 Issue 21 (Tuesday, February 2, 2016)

[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)]
[Notices]
[Page 5469]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01784]


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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.

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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, [email protected].

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

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

notices, CBER is requesting that those DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
firms that have previously applied and HUMAN SERVICES HUMAN SERVICES
are still interested in participating
reaffirm their interest. CBER is also Food and Drug Administration Food and Drug Administration
requesting that new interested parties
apply. [Docket No. FDA–2011–N–0908] [Docket No. FDA–2014–D–0609]
II. RSVP Agency Information Collection Agency Information Collection
A. Regulatory Site Visits Activities; Announcement of Office of Activities; Announcement of Office of
Management and Budget Approval; Management and Budget Approval;
In this program, over a period of time Guidance for Clinical Trial Sponsors: Guidance for Industry on Drug Supply
to be agreed upon with the facility, Establishment and Operation of Chain Security Act Implementation:
small groups of CBER staff may observe Clinical Trial Data Monitoring Identification of Suspect Product and
operations of biologics establishments, Committees Notification
including for example, blood and tissue
establishments. The visits may include AGENCY: Food and Drug Administration, AGENCY: Food and Drug Administration,
the following: (1) Packaging facilities, HHS. HHS.
(2) quality control and pathology/
ACTION: Notice. ACTION: Notice.
toxicology laboratories, and (3)
regulatory affairs operations. These
SUMMARY: The Food and Drug SUMMARY: The Food and Drug
visits, or any part of the program, are
Administration (FDA) is announcing Administration (FDA) is announcing
not intended as a mechanism to inspect,
that a collection of information entitled that a collection of information entitled
assess, judge, or perform a regulatory
‘‘Guidance for Clinical Trial Sponsors: ‘‘Guidance for Industry on Drug Supply
function, but are meant to improve
Establishment and Operation of Clinical Chain Security Act Implementation:
mutual understanding and to provide an
Trial Data Monitoring Committees’’ has Identification of Suspect Product and
avenue for open dialogue between the
been approved by the Office of Notification’’ has been approved by the
biologics industry and CBER.
Management and Budget (OMB) under Office of Management and Budget
B. Site Selection the Paperwork Reduction Act of 1995. (OMB) under the Paperwork Reduction
Act of 1995.
CBER will be responsible for all travel FOR FURTHER INFORMATION CONTACT: FDA
expenses associated with the site visits. PRA Staff, Office of Operations, Food FOR FURTHER INFORMATION CONTACT: FDA
Therefore, selection of potential and Drug Administration, 8455 PRA Staff, Office of Operations, Food
facilities will be based on the Colesville Rd., COLE–14526, Silver and Drug Administration, 8455
coordination of CBER’s priorities for Spring, MD 20993–0002, PRAStaff@ Colesville Rd., COLE–14526, Silver
staff training as well as the limited fda.hhs.gov. Spring, MD 20993–0002, PRAStaff@
available resources for this program. In fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
addition to logistical and other resource
September 22, 2015, the Agency SUPPLEMENTARY INFORMATION: On
factors to consider, a key element of site
submitted a proposed collection of September 21, 2015, the Agency
selection is a successful compliance
information entitled ‘‘Guidance for submitted a proposed collection of
record with FDA or another Agency
Clinical Trial Sponsors: Establishment information entitled ‘‘Guidance for
with which we have a memorandum of
and Operation of Clinical Trial Data Industry on Drug Supply Chain Security
understanding. If a site visit involves a
Monitoring Committees’’ to OMB for Act Implementation: Identification of
visit to a separate physical location of
review and clearance under 44 U.S.C. Suspect Product and Notification’’ to
another firm under contract to the
applicant, the other firm also needs to 3507. An Agency may not conduct or OMB for review and clearance under 44
agree to participate in the program, as sponsor, and a person is not required to U.S.C. 3507. An Agency may not
well as have a satisfactory compliance respond to, a collection of information conduct or sponsor, and a person is not
history. If you are a firm with multiple unless it displays a currently valid OMB required to respond to, a collection of
sites, please submit no more than three control number. OMB has now information unless it displays a
specific locations for consideration. approved the information collection and currently valid OMB control number.
has assigned OMB control number OMB has now approved the information
III. Requests for Participation 0910–0581. The approval expires on collection and has assigned OMB
December 31, 2018. A copy of the control number 0910–0806. The
Identify requests for participation
supporting statement for this approval expires on December 31, 2018.
with the docket number found in
information collection is available on A copy of the supporting statement for
brackets in the heading of this
the Internet at http://www.reginfo.gov/ this information collection is available
document. Received requests are
public/do/PRAMain. on the Internet at http://
available for public examination in the
Dated: January 27, 2016. www.reginfo.gov/public/do/PRAMain.
Division of Dockets Management (see
ADDRESSES) between 9 a.m. and 4 p.m., Leslie Kux, Dated: January 27, 2016.
wgreen on DSK2VPTVN1PROD with NOTICES

Monday through Friday. Associate Commissioner for Policy. Leslie Kux,
Dated: January 27, 2016. [FR Doc. 2016–01781 Filed 2–1–16; 8:45 am] Associate Commissioner for Policy.
Leslie Kux, BILLING CODE 4164–01–P [FR Doc. 2016–01784 Filed 2–1–16; 8:45 am]
BILLING CODE 4164–01–P
Associate Commissioner for Policy.
[FR Doc. 2016–01780 Filed 2–1–16; 8:45 am]
BILLING CODE 4164–01–P

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Document Created: 2016-02-02 00:32:13
Document Modified: 2016-02-02 00:32:13

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		81 FR 5469

81 FR 5469 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 21 (February 2, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration