Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Evaluation of Potential Data Sources for the Sentinel Initiative, 67983 [2010-27848]

Download as PDF Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices Dated: October 25, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. 67983 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FR Doc. 2010–27850 Filed 11–3–10; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0536] BILLING CODE 4160–01–P [Docket No. FDA–2009–N–0098] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Evaluation of Potential Data Sources for the Sentinel Initiative DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0190] AGENCY: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Formula Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Infant Formula Requirements’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 7651, e-mail: Juanmanuel.Vilela@fda.hhs.gov. In the Federal Register of August 10, 2010 (75 FR 48350), the Agency announced that the proposed information collection had been submitted 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 0910–0256. The approval expires on October 31, 2013. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. jlentini on DSKJ8SOYB1PROD with NOTICES SUPPLEMENTARY INFORMATION: Dated: October 25, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Evaluation of Potential Data Sources for the Sentinel Initiative’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3794, Jonnalynn.capezzuto@fda.hhs.gov. In the Federal Register of September 4, 2009 (74 FR 45858), the agency announced that the proposed information collection had been submitted 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 0910–0657. The approval expires on February 28, 2013. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: October 25, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–27848 Filed 11–3–10; 8:45 am] BILLING CODE 4160–01–P BILLING CODE 4160–01–P 16:47 Nov 03, 2010 Jkt 223001 PO 00000 Frm 00039 Fmt 4703 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection resulting from recommendations to sponsors submitting or holding investigational new drug applications (INDs), new drug applications (NDAs), or biologic licensing applications (BLAs) on what pharmacogenomic data should be submitted to the agency during the drug development process. DATES: Submit either electronic or written comments on the collection of information by January 3, 2011. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301–796–3792, Elizabeth.Berbakos@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in SUMMARY: Notice. [FR Doc. 2010–27849 Filed 11–3–10; 8:45 am] VerDate Mar<15>2010 Agency Information Collection Activities: Proposed Collection; Comment Request, Guidance for Industry on Pharmacogenomic Data Submissions; Extension Sfmt 4703 E:\FR\FM\04NON1.SGM 04NON1

Agencies

[Federal Register Volume 75, Number 213 (Thursday, November 4, 2010)]
[Notices]
[Page 67983]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27848]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0098]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Evaluation of Potential Data Sources 
for the Sentinel Initiative

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Evaluation of Potential Data 
Sources for the Sentinel Initiative'' has been approved by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 
1995.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3794, Jonnalynn.capezzuto@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 4, 2009 
(74 FR 45858), the agency announced that the proposed information 
collection had been submitted 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 0910-0657. 
The approval expires on February 28, 2013. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.reginfo.gov/public/do/PRAMain.

    Dated: October 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-27848 Filed 11-3-10; 8:45 am]
BILLING CODE 4160-01-P
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