Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection; Correction, 31386 [2015-13337]

Download as PDF 31386 Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices • facilitate, identify, and prioritize technical assistance and development needs, develop strategic and project plans, and allocate resources to coordinate FDA training program components for U.S. teachers actively incorporating FDA’s food safety and nutrition curriculum in their classrooms, as specified in the various training components of this proposed cooperative agreement. C. Eligibility Information The following organization is eligible to apply: Graduate School USA. • Step 6: Register With Electronic Research Administration (eRA) Commons Steps 1 through 5, in detail, can be found at https://www07.grants.gov/ applicants/organization_ registration.jsp. Step 6, in detail, can be found at https://commons.era.nih.gov/ commons/registration/ registrationInstructions.jsp. After you have followed these steps, submit electronic applications to: https:// www.grants.gov. II. Award Information/Funds Available Dated: May 28, 2015. Leslie Kux, Associate Commissioner for Policy. A. Award Amount [FR Doc. 2015–13330 Filed 6–1–15; 8:45 am] The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations, availability of funding and awardee performance. FDA/CFSAN intends to fund up to $452,700.00 for fiscal year 2015 in support of this grant program. Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect): YR 1: $452,700 YR 2: $500,000 YR 3: $500,000 YR 4: $500,000 YR 5: $500,000 BILLING CODE 4164–01–P B. Length of Support The scope of the proposed project should determine the project period. The maximum project period is 5 years. asabaliauskas on DSK5VPTVN1PROD with NOTICES III. Electronic Application, Registration, and Submission Only electronic applications will be accepted. To submit an electronic application in response to this FOA, applicants should first review the full announcement located at https:// www.grants.gov. Search by Funding Opportunity Number: RFA–FD–15–011. (FDA has verified the Web site addresses throughout this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) For all electronically submitted applications, the following steps are required. • Step 1: Obtain a Dun and Bradstreet (DUNS) Number • Step 2: Register With System for Award Management (SAM) • Step 3: Obtain Username & Password • Step 4: Authorized Organization Representative (AOR) Authorization • Step 5: Track AOR Status VerDate Sep<11>2014 17:26 Jun 01, 2015 Jkt 235001 Dated: May 28, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–13337 Filed 6–1–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0248] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level AGENCY: Food and Drug Administration, HHS. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Food and Drug Administration SUMMARY: [Docket No. FDA–2015–N–1805] Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection; Correction AGENCY: Food and Drug Administration, HHS. Notice; request for comments; correction. ACTION: The Food and Drug Administration is correcting a notice entitled ‘‘Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection’’ that appeared in the Federal Register of April 29, 2015 (80 FR 23798). The document announced the progress of the Center for Devices and Radiological Health on its 2014–2015 Strategic Priority ‘‘Strike the Right Balance Between Premarket and Postmarket Data Collection.’’ The document was published with the incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993–0002, 301–796–9115. SUPPLEMENTARY INFORMATION: In the Federal Register of April 29, 2015, in FR Doc. 2015–09884, on page 23798, the following correction is made: 1. On page 23798, in the first column, in the headings section of the document, ‘‘[Docket No. FDA–2014–D–0090]’’ is corrected to read ‘‘[Docket No. FDA– 2015–N–1805]’’. SUMMARY: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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 contained in the guidance for industry on formal dispute resolution. DATES: Submit either electronic or written comments on the collection of information by August 3, 2015. 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: 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: 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. E:\FR\FM\02JNN1.SGM 02JNN1

Agencies

[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Notices]
[Page 31386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13337]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1805]


Retrospective Review of Premarket Approval Application Devices; 
Striking the Balance Between Premarket and Postmarket Data Collection; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments; correction.

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SUMMARY: The Food and Drug Administration is correcting a notice 
entitled ``Retrospective Review of Premarket Approval Application 
Devices; Striking the Balance Between Premarket and Postmarket Data 
Collection'' that appeared in the Federal Register of April 29, 2015 
(80 FR 23798). The document announced the progress of the Center for 
Devices and Radiological Health on its 2014-2015 Strategic Priority 
``Strike the Right Balance Between Premarket and Postmarket Data 
Collection.'' The document was published with the incorrect docket 
number. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and 
Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 29, 2015, 
in FR Doc. 2015-09884, on page 23798, the following correction is made:
    1. On page 23798, in the first column, in the headings section of 
the document, ``[Docket No. FDA-2014-D-0090]'' is corrected to read 
``[Docket No. FDA-2015-N-1805]''.

    Dated: May 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13337 Filed 6-1-15; 8:45 am]
 BILLING CODE 4164-01-P
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