80 FR 67764 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry and Food and Drug Administration Staff-Class II Special Controls Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 212 (November 3, 2015)

Page Range		67764-67764
FR Document		2015-27970

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry and Food and Drug Administration Staff--Class II Special Controls Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 80 Issue 212 (Tuesday, November 3, 2015)

[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)]
[Notices]
[Page 67764]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27970]



[[Page 67764]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0115]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry and Food and 
Drug Administration Staff--Class II Special Controls Automated Blood 
Cell Separator Device Operating by Centrifugal or Filtration Separation 
Principle

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 and Food and 
Drug Administration Staff--Class II Special Controls Automated Blood 
Cell Separator Device Operating by Centrifugal or Filtration Separation 
Principle'' 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 June 29, 2015, the Agency submitted a 
proposed collection of information entitled ``Guidance for Industry and 
Food and Drug Administration Staff--Class II Special Controls Automated 
Blood Cell Separator Device Operating by Centrifugal or Filtration 
Separation Principle'' 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 0910-0594. 
The approval expires on September 30, 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: October 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27970 Filed 11-2-15; 8:45 am]
 BILLING CODE 4164-01-P

67764 Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices

DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
HUMAN SERVICES HUMAN SERVICES HUMAN SERVICES

Food and Drug Administration Food and Drug Administration Food and Drug Administration
[Docket No. FDA–2015–N–3921]
[Docket No. FDA–2012–N–0115] [Docket No. FDA–2014–N–2076]
Health Canada and United States Food
Agency Information Collection Agency Information Collection and Drug Administration Joint Public
Activities; Announcement of Office of Activities; Announcement of Office of Consultation on International
Management and Budget Approval; Management and Budget Approval; Conference on Harmonisation of
Guidance for Industry and Food and Survey on Occurrence of Foodborne Technical Requirements for
Drug Administration Staff—Class II Illness Risk Factors in Selected Retail Registration of Pharmaceuticals for
Special Controls Automated Blood Cell and Foodservice Facility Types Human Use; Public Webinar; Request
Separator Device Operating by for Comments
Centrifugal or Filtration Separation AGENCY: Food and Drug Administration,
Principle AGENCY: Food and Drug Administration,
HHS. HHS.
AGENCY: Food and Drug Administration, ACTION: Notice. ACTION: Notice of public webinar;
HHS. request for comments.
ACTION: Notice. SUMMARY: The Food and Drug SUMMARY: The Food and Drug
Administration (FDA) is announcing Administration (FDA or Agency) is
SUMMARY: The Food and Drug that a collection of information entitled announcing a regional public webinar
Administration (FDA) is announcing ‘‘Survey on Occurrence of Foodborne entitled ‘‘Health Canada and U.S. Food
that a collection of information entitled Illness Risk Factors in Selected Retail and Drug Administration Joint Public
‘‘Guidance for Industry and Food and and Foodservice Facility Types’’ has Consultation on International
Drug Administration Staff—Class II been approved by the Office of Conference on Harmonisation of
Special Controls Automated Blood Cell Management and Budget (OMB) under Technical Requirements for Registration
Separator Device Operating by the Paperwork Reduction Act of 1995. of Pharmaceuticals for Human Use
Centrifugal or Filtration Separation (ICH).’’ The goal of this webinar is to
FOR FURTHER INFORMATION CONTACT: FDA provide information and receive
Principle’’ has been approved by the
PRA Staff, Office of Operations, Food comments on the ICH, as well as the
Office of Management and Budget
and Drug Administration, 8455 upcoming ICH meetings in Jacksonville,
(OMB) under the Paperwork Reduction
Act of 1995. Colesville Rd., COLE–14526, Silver FL, in December 2015. The topics to be
Spring, MD 20993–0002, PRAStaff@ discussed are the topics for discussion
FOR FURTHER INFORMATION CONTACT: FDA fda.hhs.gov. at the forthcoming ICH Management
PRA Staff, Office of Operations, Food Steering Meeting. The purpose of the
and Drug Administration, 8455 SUPPLEMENTARY INFORMATION: On August
webinar is to solicit public input prior
Colesville Rd., COLE–14526, Silver 18, 2015, the Agency submitted a
to the next Steering Committee and
Spring, MD 20993–0002, PRAStaff@ proposed collection of information Expert Working Group meetings in
fda.hhs.gov. entitled ‘‘Survey on Occurrence of Jacksonville, FL, scheduled for
Foodborne Illness Risk Factors in December 5 to 10, 2015, at which the
SUPPLEMENTARY INFORMATION: On June Selected Retail and Foodservice Facility
29, 2015, the Agency submitted a discussion of the topics underway and
Types’’ to OMB for review and ICH reforms will continue.
proposed collection of information
clearance under 44 U.S.C. 3507. An DATES: The public webinar will be held
entitled ‘‘Guidance for Industry and
Agency may not conduct or sponsor, on November 12, 2015, from 1 p.m. to
Food and Drug Administration Staff—
Class II Special Controls Automated and a person is not required to respond 4 p.m., Eastern Standard Time.
Blood Cell Separator Device Operating to, a collection of information unless it Registration to attend the webinar and
by Centrifugal or Filtration Separation displays a currently valid OMB control requests for online presentations must
Principle’’ to OMB for review and number. OMB has now approved the be received by November 6, 2015. See
clearance under 44 U.S.C. 3507. An information collection and has assigned the SUPPLEMENTARY INFORMATION section
Agency may not conduct or sponsor, OMB control number 0910–0744. The for information on how to register for
and a person is not required to respond approval expires on September 30, the webinar. Interested persons may
to, a collection of information unless it 2018. A copy of the supporting submit either electronic or written
displays a currently valid OMB control statement for this information collection comments to the public docket (see
number. OMB has now approved the is available on the Internet at http:// ADDRESSES) by December 12, 2015.
information collection and has assigned www.reginfo.gov/public/do/PRAMain. ADDRESSES: You may submit comments
OMB control number 0910–0594. The Dated: October 28, 2015. as follows:
approval expires on September 30,
Leslie Kux, Electronic Submissions
2018. A copy of the supporting
statement for this information collection Associate Commissioner for Policy. Submit electronic comments in the
mstockstill on DSK4VPTVN1PROD with NOTICES

is available on the Internet at http:// [FR Doc. 2015–27944 Filed 11–2–15; 8:45 am] following way:
www.reginfo.gov/public/do/PRAMain. BILLING CODE 4164–01–P • Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
Dated: October 28, 2015. instructions for submitting comments.
Leslie Kux, Comments submitted electronically,
Associate Commissioner for Policy. including attachments, to http://
[FR Doc. 2015–27970 Filed 11–2–15; 8:45 am] www.regulations.gov will be posted to
BILLING CODE 4164–01–P the docket unchanged. Because your

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Document Created: 2018-03-01 11:32:29
Document Modified: 2018-03-01 11:32:29

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		80 FR 67764

80 FR 67764 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry and Food and Drug Administration Staff-Class II Special Controls Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 212 (November 3, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration