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, 5764 [2016-01885]

Download as PDF 5764 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices information collection is available on the Internet at http://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 http://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 http://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: mstockstill on DSK4VPTVN1PROD with NOTICES Food and Drug Administration, HHS. VerDate Sep<11>2014 19:14 Feb 02, 2016 Jkt 238001 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 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: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// 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 http://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: 2016-01885]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0915]


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

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 
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.

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 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 http://www.reginfo.gov/public/do/PRAMain.

    Dated: January 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01885 Filed 2-2-16; 8:45 am]
 BILLING CODE 4164-01-P