79 FR 177 pg. 54728 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Providing Waiver-Related Materials in Accordance With Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
Type: NOTICEVolume: 79Number: 177Page: 54728
Page: 54728Docket number: [Docket No. FDA-2013-D-1478]
FR document: [FR Doc. 2014-21726 Filed 9-11-14; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1478]
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Providing Waiver-Related Materials in Accordance With Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing that a collection of information entitled Providing Waiver-Related Materials in Accordance with Draft Guidance for Industry on Providing "Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format" has been approved by the Office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 June 19, 2014, the Agency submitted a proposed collection of information entitled "Providing Waiver-Related Materials in Accordance with Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format" to OMB for review and clearance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 0910-0771. The approval expires on August 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain .
Dated: September 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21726 Filed 9-11-14; 8:45 am]
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