81 FR 5468 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range		5468-5468
FR Document		2016-01785

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.

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

[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)]
[Notices]
[Page 5468]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01785]


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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, [email protected].

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

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

Workshop objectives will include SUMMARY: The Food and Drug including its challenges and operations.
discussion and identification of Administration (FDA) is announcing The purpose of this document is to
promising innovations that could that a collection of information entitled invite biologics facilities to contact
facilitate successful trials in OA, new ‘‘Improving Food Safety and Defense CBER for more information if they are
approaches to recruitment for clinical Capacity of the State and Local Level: interested in participating in this
trials, feasible and clinically meaningful Review of State and Local Capacities’’ program.
trial endpoints, and approaches for has been approved by the Office of DATES: Submit either an electronic or
reducing the time and cost of OA trials Management and Budget (OMB) under written request for participation in this
while maximizing the likelihood of the Paperwork Reduction Act of 1995. program by March 3, 2016. The request
success. FOR FURTHER INFORMATION CONTACT: FDA should include a description of your
Registration: There is no fee to attend PRA Staff, Office of Operations, Food facility relative to products regulated by
the workshop, but attendees must and Drug Administration, 8455 CBER. Please specify the physical
register in advance. Space is very Colesville Rd., COLE–14526, Silver address(es) of the site(s) you are
limited. Persons interested in attending Spring, MD 20993–0002, PRAStaff@ offering.
this workshop may request to register by fda.hhs.gov. ADDRESSES: If your biologics facility is
sending their resume and inquiry to SUPPLEMENTARY INFORMATION: On interested in offering a site visit, submit
AFScience@arthritis.org. The November 30, 2015, the Agency either an electronic request to http://
registration deadline is February 2, submitted a proposed collection of www.regulations.gov or a written
2016. information entitled ‘‘Improving Food request to the Division of Dockets
II. Accommodations Safety and Defense Capacity of the State Management (HFA–305), Food and Drug
and Local Level: Review of State and Administration, 5630 Fishers Lane, Rm.
An online registration link and a
Local Capacities’’ to OMB for review 1061, Rockville, MD 20852. If you
meeting code will be provided through
and clearance under 44 U.S.C. 3507. An previously responded to earlier requests
the registration process giving
Agency may not conduct or sponsor, to participate in this program and you
participants a reduced group rate for
and a person is not required to respond continue to be interested in
hotel accomodations, not including
to, a collection of information unless it participating, please renew your request
applicable taxes. No additional
displays a currently valid OMB control through a submission to the Division of
reservations are required. Industry and
number. OMB has now approved the Dockets Management.
government attendees are responsible
information collection and has assigned FOR FURTHER INFORMATION CONTACT:
for the cost of their own accomodations.
OMB control number 0910–0726. The Cynthia Whitmarsh, Division of
If you need special accommodations
approval expires on January 31, 2019. A Manufacturers Assistance and Training,
due to a disability, please contact Becky
copy of the supporting statement for this Center for Biologics Evaluation and
Bosworth at bbosworth@arthritis.org at
information collection is available on Research, Food and Drug
least 7 days in advance.
the Internet at http://www.reginfo.gov/ Administration, 10903 New Hampshire
III. Transcripts public/do/PRAMain. Ave., Bldg. 71, Rm. G112, Silver Spring,
No transcripts will be available from Dated: January 27, 2016. MD 20993–0002, 240–402–8010, FAX:
the event, however, the event will be Leslie Kux, 301–595–1243, email:
video taped for the purposes of the Industry.Biologics@fda.hhs.gov.
Associate Commissioner for Policy
Arthritis Foundation. Speaker SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–01785 Filed 2–1–16; 8:45 am]
presentation materials, if permitted by BILLING CODE 4164–01–P I. Background
the presenter, will be available on the
CBER regulates certain biological
Arthritis Foundation Web site following
products including blood and blood
the workshop. DEPARTMENT OF HEALTH AND products, vaccines, and cellular, tissue,
Dated: January 27, 2016. HUMAN SERVICES and gene therapies. CBER is committed
Leslie Kux, to advancing the public health through
Food and Drug Administration
Associate Commissioner for Policy. innovative activities that help ensure
[FR Doc. 2016–01789 Filed 2–1–16; 8:45 am] [Docket No. FDA–2016–N–0275] the safety, effectiveness, and availability
BILLING CODE 4164–01–P of biological products to patients. To
Regulatory Site Visit Training Program support this primary goal, CBER has
AGENCY: Food and Drug Administration, initiated various training and
DEPARTMENT OF HEALTH AND HHS. development programs, including
HUMAN SERVICES ACTION: Notice. programs to further enhance
performance of its compliance staff,
Food and Drug Administration SUMMARY: The Food and Drug regulatory review staff, and other
Administration’s (FDA’s) Center for relevant staff. CBER seeks to
[Docket No. FDA–2012–N–0145] Biologics Evaluation and Research continuously enhance and update
(CBER) is announcing an invitation for review efficiency and quality, and the
Agency Information Collection participation in its Regulatory Site Visit quality of its regulatory efforts and
Activities; Announcement of Office of Training Program (RSVP). This training interactions, by providing CBER staff
Management and Budget Approval; program is intended to give CBER with a better understanding of the
wgreen on DSK2VPTVN1PROD with NOTICES

Improving Food Safety and Defense regulatory review, compliance, and biologics industry and its operations.
Capacity of the State and Local Level: other relevant staff an opportunity to Further, CBER seeks to enhance: (1) Its
Review of State and Local Capacities visit biologics facilities. These visits are understanding of current industry
AGENCY: Food and Drug Administration, intended to allow CBER staff to directly practices and regulatory impacts and
HHS. observe routine manufacturing practices needs and (2) communication between
and to give CBER staff a better CBER staff and industry. CBER initiated
ACTION: Notice.
understanding of the biologics industry, its RSVP in 2005. Through these annual

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Document Modified: 2016-02-02 00:32:01

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 5468

81 FR 5468 - 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

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