Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Postmarketing Adverse Drug Experience Reporting, 5764 [2016-01884]
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5764
Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: January 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2015–D–4848]
[Docket No. FDA–2011–N–0915]
[FR Doc. 2016–01883 Filed 2–2–16; 8:45 am]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry on
Postmarketing Adverse Event
Reporting for Nonprescription Human
Drug Products Marketed Without an
Approved Application
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0253]
AGENCY:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Postmarketing Adverse Drug
Experience Reporting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Postmarketing Adverse Drug
Experience Reporting’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry on
Postmarketing Adverse Event Reporting
for Nonprescription Human Drug
Products Marketed Without an
Approved Application’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On July 1,
2015, the Agency submitted a proposed
collection of information entitled
‘‘Postmarketing Adverse Drug
Experience Reporting’’ 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
0910–0230. The approval expires on
December 31, 2018. A copy of the
supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
On July 2,
2015, the Agency submitted a proposed
collection of information entitled
‘‘Guidance for Industry on
Postmarketing Adverse Event Reporting
for Nonprescription Human Drug
Products Marketed Without an
Approved Application’’ 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
0910–0636. The approval expires on
December 31, 2018. A copy of the
supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: January 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Dated: January 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–01884 Filed 2–2–16; 8:45 am]
[FR Doc. 2016–01885 Filed 2–2–16; 8:45 am]
BILLING CODE 4164–01–P
BILLING CODE 4164–01–P
SUPPLEMENTARY INFORMATION:
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Food and Drug Administration,
HHS.
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SUPPLEMENTARY INFORMATION:
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Human Factors Studies and Related
Clinical Study Considerations in
Combination Product Design and
Development; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry and FDA staff
entitled ‘‘Human Factors Studies and
Related Clinical Study Considerations
in Combination Product Design and
Development.’’ This document provides
guidance to industry and FDA staff on
the underlying principles of human
factors (HF) studies during the
development of combination products.
Combination products are comprised of
any combination of a drug and a device;
a device and a biological product; a
biological product and a drug; or a drug,
a device, and a biological product.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 3, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
E:\FR\FM\03FEN1.SGM
03FEN1
]]>Agencies
[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Page 5764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01884]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0253]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Postmarketing Adverse Drug
Experience Reporting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Postmarketing Adverse Drug
Experience Reporting'' 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 July 1, 2015, the Agency submitted a
proposed collection of information entitled ``Postmarketing Adverse
Drug Experience Reporting'' 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 0910-0230.
The approval expires on December 31, 2018. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: January 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01884 Filed 2-2-16; 8:45 am]
BILLING CODE 4164-01-P
