Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Third Party Review Program Under the Food and Drug Administration Modernization Act, 13623 [2011-5738]

Download as PDF Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices NIOSH recognizes this opportunity will raise many questions for prospective partners. In order to give all involved the greatest opportunity to understand the process and project expectations, the NTEA–AMD, our collaborative partner and host standards setting body, has agreed to provide a meeting room for us to hold an informational meeting to present a broad overview of the effort and answer any resulting questions. To provide us with the best opportunity to meet the needs of all prospective partners at each of these meetings, we request that all interested parties contact Jim Green, NIOSH Project Officer, by email at JGreen@cdc.gov; or telephone (304) 285–5857, by Thursday, March 17, 2011. CONTACT PERSON FOR MORE INFORMATION: Jim Green, NIOSH Project Officer, email: JGreen@cdc.gov; telephone (304) 285–5857. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. FOR FURTHER INFORMATION CONTACT: Dated: March 7, 2011. Tanja Popovic, Deputy Associate Director for Science, Centers for Disease Control and Prevention. Food and Drug Administration [FR Doc. 2011–5733 Filed 3–11–11; 8:45 am] BILLING CODE 4163–19–P Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Medical Devices; Third Party Review Program Under the Food and Drug Administration Modernization Act’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. mstockstill on DSKH9S0YB1PROD with NOTICES 16:20 Mar 11, 2011 Jkt 223001 DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2011–N–0116] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations Food and Drug Administration, 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 medical device labeling regulations. DATES: Submit either electronic or written comments on the collection of information by May 13, 2011. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written SUMMARY: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Third Party Review Program Under the Food and Drug Administration Modernization Act VerDate Mar<15>2010 BILLING CODE 4160–01–P ACTION: [Docket No. FDA–2010–N–0447] SUMMARY: [FR Doc. 2011–5738 Filed 3–11–11; 8:45 am] HHS. Food and Drug Administration ACTION: Dated: March 8, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, Daniel.Gittleson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of December 28, 2010 (75 FR 81616), 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 0910–0375. The approval expires on February 28, 2014. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 13623 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: Daniel Gittleson, Office of Information Management, PI50–400B, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301–796–5156, Daniel.Gittleson@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 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements 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 proposed collection of information, including each proposed extension of an existing collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Medical Device Labeling Regulations— (OMB Control Number 0910–0485)— (Extension) Section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352), among other things, establishes requirements for the label or labeling of a medical device so that it is not misbranded and subject to a E:\FR\FM\14MRN1.SGM 14MRN1

Agencies

[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Page 13623]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5738]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0447]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Medical Devices; Third Party Review 
Program Under the Food and Drug Administration Modernization Act

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 ``Medical Devices; Third Party 
Review Program Under the Food and Drug Administration Modernization 
Act'' has been approved by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:  Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 28, 2010 
(75 FR 81616), 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 0910-0375. 
The approval expires on February 28, 2014. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.reginfo.gov/public/do/PRAMain.

    Dated: March 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5738 Filed 3-11-11; 8:45 am]
BILLING CODE 4160-01-P
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