Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Abbreviated New Animal Drug Applications
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Prospective Grant of Exclusive Patent License: Development of Integrin αvβ3 Antagonists for Use in Imaging and Therapy
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Cancer Institute (NCI) and the Clinical Center (CC), National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an exclusive license to Advanced Imaging Projects, LLC, a company having a place of business in Boca Raton, FL, to practice the inventions embodied in the following patent applications:
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the information collection request Airline and Traveler Information Collection: Domestic Manifests and the Passenger Locator Form. This information aligns with current activities with regard to the collection of manifests from domestic flights within the United States, as well as the collection of traveler information using the Passenger Locator Form (PLF) on both international and domestic flights, in the event that a communicable disease has been confirmed during travel that puts other passengers at risk.
Secretarial Review and Publication of the National Quality Forum Annual Report to Congress and the Secretary Submitted by the Consensus-Based Entity Regarding Performance Measurement
This notice acknowledges the Secretary of the Department of Health and Human Services' (HHS) receipt and review of the 2016 National Quality Forum Annual Report to Congress and the Secretary submitted by the consensus-based entity (CBE) under a contract with the Secretary as mandated by section 1890(b)(5) of the Social Security Act, established by section 183 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) and amended by section 3014 of the Patient Protection and Affordable Care Act of 2010. The statute requires the Secretary to review and publish the report in the Federal Register together with any comments of the Secretary on the report not later than six months after receiving the report. This notice fulfills the statutory requirements.
World Trade Center Health Program; Petition 013-Autoimmune Disease; Finding of Insufficient Evidence
On April 4, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 013) to add ``relapsing remitting multiple sclerosis (autoimmune)'' to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 013 is not substantially different from Petitions 007, 008, 009, and 011, which also requested the addition of autoimmune diseases, including various subtypes. The Administrator recently published responses to the four previous petitions in the Federal Register and has determined that Petition 013 does not provide additional evidence of a causal relationship between 9/11 exposures and autoimmune diseases, including multiple sclerosis. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing a 2-day public hearing to obtain input on issues related to communications by manufacturers, packers, and distributors, including their representatives (collectively ``firms''), regarding FDA-regulated drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs (collectively, ``medical products''). FDA is engaged in a comprehensive review of its regulations and policies governing firms' communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform FDA's policy development in this area. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.
Request for Public Comment: 30-Day Proposed Information Collection: Application for Participation in the IHS Scholarship Program
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for an extension for this collection, titled, ``Application for Participation in the IHS Scholarship Program (OMB Control Number 0917- 0006),'' with an expiration date of September 30, 2016. This proposed information collection project was previously published in the Federal Register (81 FR 44030) on July 6, 2016, and allowed 60 days for public comment, as required by 3506(c)(2)(A). The IHS received no comments regarding this collection. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: ``Application for Participation in the IHS Scholarship Program,'' OMB Control No. 0917-0006. Type of Information Collection Request: Extension of the currently approved information collection ``Application for Participation in the IHS Scholarship Program,'' OMB Control No. 0917-0006. Form Number(s): IHS- 856-3, IHS-856-5 through 856-19, IHS-856-21 through 856-24, IHS-817, and IHS-818 are retained for use by the IHS Scholarship Program (IHSSP) as part of this current information collection request. Reporting forms are found on the IHS Web site at www.ihs.gov/scholarship. Need and Use of Information Collection: The IHS Scholarship Branch needs this information for program administration and uses the information to: solicit, process, and award IHS Pre-graduate, Preparatory, and/or Health Professions Scholarship recipients; monitor the academic performance of recipients; and to place recipients at payback sites. The IHSSP application is electronically available on the internet at the IHS Web site at: https://www.ihs.gov/scholarship/applynow/. Affected Public: Individuals, not-for-profit institutions and State, local or Tribal Governments. Type of Respondents: Students pursuing health care professions. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hours.
Tribal Consultation Meetings
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of a 1-day Tribal Consultation Session to be held between the Department of Health and Human Services (HHS), Administration for Children and Families, OHS leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)].
The Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``The Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program.'' The purpose of the workshop is to describe the Sentinel Initiative and PRISM program, illustrate how PRISM is used by FDA for regulatory responsibilities (including how it has been integrated into FDA's regulatory review process and case examples), and discuss the future direction of PRISM in terms of expansion and further integration into the regulatory review process.
Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee, Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Cardiovascular and Renal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Cardiovascular and Renal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until August 27, 2018.
Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee, Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Endocrinologic and Metabolic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until August 27, 2018.
Announcement of the Award of Single-Source Grants Under the Wilson-Fish Alternative Program (W-F); Correction; CFDA Number: 93.583
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), published a document in the Federal Register of August 22, 2016, concerning the announcement of the award of 13 single-source grants for a total of $35,513,938 under the W-F Alternative Program. The document contained an incorrect address and telephone number.
National Institute on Deafness and Other Communication Disorders Draft 2017-2021 Strategic Plan
The National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH) is requesting public comment on the draft 2017-2021 NIDCD Strategic Plan. The Strategic Plan serves as a guide to the NIDCD in prioritizing its research investment, illustrates the current state-of-the-science, and highlights recent advances in the communication sciences. The draft Plan presents a series of goals and objectives that represent the most promising research needs within the NIDCD's mission areas.