Pilot Program for Parallel Review of Medical Products; Correction, 66309 [2011-27694]

Download as PDF Federal Register / Vol. 76, No. 207 / Wednesday, October 26, 2011 / Notices Department of Health and Human Services (45 FR 67772–76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 76 FR 50223—50224, dated August 12, 2011) is amended to reflect the reorganization of the Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention. Section C–B, Organization and Functions, is hereby amended as follows: After item (7) in the functional statement for the Office of Public Health Preparedness and Response (CG), Division of Strategic National Stockpile (CGE), Office of the Director (CGE1), insert the following: And (8) provides leadership, guidance, and technical assistance to state, tribal and local territories for healthcare preparedness and emergency response and for the integration of preparedness planning across the public health, healthcare, and emergency management sectors. Dated: October 14, 2011. Sherri A. Berger, Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2011–27497 Filed 10–25–11; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4434, Silver Spring, MD 20993–0002, 301–796–6579. SUPPLEMENTARY INFORMATION: In FR Doc. 2011–25907, appearing on page 62808 in the Federal Register of Tuesday, October 11, 2011, the following corrections are made: 1. On page 62808, in the third column, under the heading ‘‘A. Parallel Review Proposal,’’ the Web site address ‘‘http://www.parallel-review.fda.gov’’ is corrected to read ‘‘http://www.fda.gov/ parallel-review’’. 2. On page 62809, in the second column, under the heading ‘‘B. Appropriate Candidates,’’ the e-mail address ‘‘parallel-review@fda.gov’’ is corrected to read ‘‘parallelreview@fda.hhs.gov’’. 3. On page 62809, in the third column, under the heading ‘‘1. Nomination,’’ the Web site address ‘‘http://www.parallel-review.fda.gov’’ is corrected to read ‘‘http://www.fda.gov/ parallel-review’’. Dated: October 17, 2011. Jacquelyn Y. White, Director, Office of Strategic Operations and Regulatory Affairs. Centers for Medicare & Medicaid Services. Dated: October 19, 2011. Leslie Kux, Acting Assistant Commissioner for Policy, Food and Drug Administration. [FR Doc. 2011–27694 Filed 10–25–11; 8:45 am] BILLING CODE 4160–01–P [CMS–3180–N2] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0308] Administration for Children and Families Pilot Program for Parallel Review of Medical Products; Correction Food and Drug Administration, Centers for Medicare and Medicaid Services, HHS. ACTION: Notice; correction. AGENCY: The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) are correcting a notice that appeared in the Federal Register of October 11, 2011 (76 FR 62808). The document announced a pilot program for sponsors of innovative device technologies to participate in a program of parallel FDA–CMS review. The document was published with an incorrect Web page address and an incorrect email address. This document corrects those errors. FOR FURTHER INFORMATION CONTACT: Jean Olson, Center for Devices and jlentini on DSK4TPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:53 Oct 25, 2011 Jkt 226001 Proposed Information Collection Activity; Comment Request Title: Affordable Care Act Tribal Maternal, Infant and Early Childhood Home Visiting Program Annual Report. OMB No.: New. Description Section 511(h)(2)(A) of Title V of the Social Security Act, as added by Section 2951 of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111–148, Affordable Care Act or ACA), authorizes the Secretary of HHS to award grants to Indian Tribes (or a consortium of Indian Tribes), Tribal Organizations, or Urban Indian Organizations to conduct an early childhood home visiting program. The legislation sets aside 3 percent of the total ACA Maternal, Infant, and PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 66309 Early Childhood Home Visiting Program appropriation (authorized in Section 511(j)) for grants to Tribal entities and requires that the Tribal grants, to the greatest extent practicable, be consistent with the requirements of the Maternal, Infant, and Early Childhood Home Visiting Program grants to States and territories (authorized in Section 511(c)), and include (1) Conducting a needs assessment similar to the assessment required for all States under the legislation and (2) establishing quantifiable, measurable 3- and 5-year benchmarks consistent with the legislation. The Administration for Children and Families, Office of Child Care, in collaboration with the Health Resources and Services Administration, Maternal and Child Health Bureau, has awarded grants for the Tribal Maternal, Infant, and Early Childhood Home Visiting Program (Tribal Home Visiting). The Tribal Home Visiting grant awards support 5-year cooperative agreements to conduct community needs assessments, plan for and implement (in accordance with an Implementation Plan submitted at the end of Year 1) high-quality, culturally-relevant, evidence-based and promising home visiting programs in at-risk Tribal communities, and participate in research and evaluation activities to build the knowledge base on home visiting among Native populations. In the Affordable Care Act Tribal Maternal, Infant, and Early Childhood Home Visiting Program Needs Assessment and Plan for Responding to Identified Needs (‘‘Implementation Plan Guidance’’) (OMB Control No. 0970– 0389, Expiration Date 6/30/14), grantees were notified that in Years 2–5 of their grant they must comply with the requirement for submission of an Annual Report to the Secretary regarding the program and activities carried out under the program. This Report Shall Address the Following Home Visiting Program Goals and Objectives. Implementation of Home Visiting Program in Targeted Community(ies). Progress toward Meeting Legislatively Mandated Benchmark Requirements. Research and Evaluation Update. Home Visiting Program Continuous Quality Improvement (CQI) Efforts. Administration of Home Visiting Program. Technical Assistance Needs. Respondents E:\FR\FM\26OCN1.SGM 26OCN1

Agencies

[Federal Register Volume 76, Number 207 (Wednesday, October 26, 2011)]
[Notices]
[Page 66309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27694]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[CMS-3180-N2]

Food and Drug Administration

[Docket No. FDA-2010-N-0308]


Pilot Program for Parallel Review of Medical Products; Correction

AGENCY: Food and Drug Administration, Centers for Medicare and Medicaid 
Services, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) and the Centers for 
Medicare and Medicaid Services (CMS) are correcting a notice that 
appeared in the Federal Register of October 11, 2011 (76 FR 62808). The 
document announced a pilot program for sponsors of innovative device 
technologies to participate in a program of parallel FDA-CMS review. 
The document was published with an incorrect Web page address and an 
incorrect email address. This document corrects those errors.

FOR FURTHER INFORMATION CONTACT: Jean Olson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 4434, Silver Spring, MD 20993-0002, 301-796-6579.

SUPPLEMENTARY INFORMATION: In FR Doc. 2011-25907, appearing on page 
62808 in the Federal Register of Tuesday, October 11, 2011, the 
following corrections are made:
    1. On page 62808, in the third column, under the heading ``A. 
Parallel Review Proposal,'' the Web site address ``http://www.parallel-review.fda.gov'' is corrected to read ``http://www.fda.gov/parallel-review''.
    2. On page 62809, in the second column, under the heading ``B. 
Appropriate Candidates,'' the e-mail address ``parallel-review@fda.gov'' is corrected to read ``parallel-review@fda.hhs.gov''.
    3. On page 62809, in the third column, under the heading ``1. 
Nomination,'' the Web site address ``http://www.parallel-review.fda.gov'' is corrected to read ``http://www.fda.gov/parallel-review''.

    Dated: October 17, 2011.
Jacquelyn Y. White,
Director, Office of Strategic Operations and Regulatory Affairs. 
Centers for Medicare & Medicaid Services.
    Dated: October 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy, Food and Drug Administration.
[FR Doc. 2011-27694 Filed 10-25-11; 8:45 am]
BILLING CODE 4160-01-P