Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Third-Party Review Under the Food and Drug Administration Modernization Act, Third-Party Premarket Submission Review, and Quality System Inspections Under the United States/European Community Mutual Recognition Agreement, 22882 [05-8736]

Download as PDF 22882 Federal Register / Vol. 70, No. 84 / Tuesday, May 3, 2005 / Notices Dated: April 26, 2005. William P. Nichols, Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention. [FR Doc. 05–8747 Filed 5–2–05; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0157] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N–0436] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Registration and Listing Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Medical Device Registration and Listing’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1223. In the Federal Register of January 13, 2005 (70 FR 2413), 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 0910–0387. The approval expires on April 30, 2008. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. SUPPLEMENTARY INFORMATION: Dated: April 26, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–8735 Filed 5–2–05; 8:45 am] BILLING CODE 4160–01–S Food and Drug Administration [Docket No. 2004N–0437] BILLING CODE 4163–18–P AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Third-Party Review Under the Food and Drug Administration Modernization Act, Third-Party Premarket Submission Review, and Quality System Inspections Under the United States/European Community Mutual Recognition Agreement AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Third Party Review Under the Food and Drug Administration Modernization Act, Third-Party Premarket Submission Review, and Quality System Inspections Under the United States/European Community Mutual Recognition Agreement’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1223. In the Federal Register of January 5, 2005 (70 FR 821), 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 0910–0378. The approval expires on April 30, 2008. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. SUPPLEMENTARY INFORMATION: Dated: April 26, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–8736 Filed 5–2–05; 8:45 am] BILLING CODE 4160–01–S VerDate jul<14>2003 15:43 May 02, 2005 Jkt 205001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Drug Experience Reporting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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 postmarketing adverse drug experience reporting and recordkeeping requirements. DATES: Submit written or electronic comments on the collection of information by July 5, 2005. ADDRESSES: Submit electronic comments on the collection of information to https://www.fda.gov/ dockets/ecomments. 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: Karen L. Nelson, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1482. 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 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirement that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each E:\FR\FM\03MYN1.SGM 03MYN1

Agencies

[Federal Register Volume 70, Number 84 (Tuesday, May 3, 2005)]
[Notices]
[Page 22882]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8736]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0437]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Third-Party Review Under the Food 
and Drug Administration Modernization Act, Third-Party Premarket 
Submission Review, and Quality System Inspections Under the United 
States/European Community Mutual Recognition Agreement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Third Party Review Under the Food 
and Drug Administration Modernization Act, Third-Party Premarket 
Submission Review, and Quality System Inspections Under the United 
States/European Community Mutual Recognition Agreement'' has been 
approved by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 5, 2005 
(70 FR 821), 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 0910-0378. 
The approval expires on April 30, 2008. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.fda.gov/ohrms/dockets.

    Dated: April 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8736 Filed 5-2-05; 8:45 am]
BILLING CODE 4160-01-S
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