Solicitation of Written Comments on the Maternal Immunizations Working Group Phase II's Draft Report and Draft Recommendations for Overcoming Barriers and Identifying Opportunities for Developing Maternal Immunizations for Consideration by the National Vaccine Advisory Committee
The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2105) (42 U.S. Code Section 300aa-5). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to the program's responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services (HHS) as the Director of the National Vaccine Program. The National Vaccine Program Office (NVPO) is located within the Office of the Assistant Secretary for Health (OASH), Office of the Secretary, U.S. Department of Health and Human Services (HHS). The NVPO provides leadership and fosters collaboration among the various federal agencies involved in vaccine and immunization activities. The NVPO also provides management and support services for the National Vaccine Advisory Committee (NVAC). The NVAC advises and makes recommendations to the ASH in his/her capacity as the Director of the National Vaccine Program on matters related to the program's responsibilities. Recognizing the importance and impact of maternal immunizations on public health, the ASH charged the NVAC in June 2012 with reviewing the state of maternal immunizations and existing best practices to identify programmatic gaps and/or barriers to the implementation of current recommendations regarding maternal immunization. The NVAC established the Maternal Immunization Working Group (MIWG) in August 2012 to conduct these assessments and provide recommendations for overcoming any identified barriers. Through a series of teleconferences, electronic communications, and public discussions during the NVAC meetings, the working group identified a number of draft recommendations for consideration by the NVAC. These recommendations represent opportunities for developing and licensing new vaccines for pregnant women. The draft report and draft recommendations from the working group will inform NVAC deliberations as the NVAC finalizes their recommendations for transmittal to the ASH. On behalf of NVAC, NVPO is soliciting public comment on the draft report and draft recommendations from a variety of stakeholders, including the general public, for consideration by the NVAC as they develop their final recommendations to the ASH. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented to the NVAC for adoption in September 2016 at the quarterly NVAC meeting.
Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria; Correction
The Department of Health and Human Services published a document in the Federal Register of August 18, 2016, containing language indicating that a meeting is tentatively scheduled to be held of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council) on September 19, 2016. The DATES AND TIMES section contained incorrect language.
National Vaccine Injury Compensation Program; List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Microbiology Data for Systemic Antibacterial Drugs-Development, Analysis, and Presentation; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Microbiology Data for Systemic Antibacterial DrugsDevelopment, Analysis, and Presentation.'' The purpose of this guidance is to assist sponsors in the development, analysis, and presentation of microbiology data during antibacterial drug development. This guidance finalizes the draft guidance of the same name issued on September 17, 2009.
Agency Information Collection Activities; Proposed Collection; Comment Request; User Account Management Function for the Import Trade Auxiliary Communication System
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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information required to implement user account management function in FDA's Import Trade Auxiliary Communication System (ITACS). Secure user accounts will allow import trade users to receive Notices of FDA Action and requests for specific information via email or via download within ITACS.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development 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 and/or co-development.
Notice of Adoption of the Health and Human Services Acquisition Regulations (HHSAR) and OIG Class Deviations
This announcement establishes that the OIG contracting activity will follow the requirements of the HHSAR, subject to three deviations establishing that OIG personnel shall seek legal guidance from the Office of Counsel to the Inspector General instead of the Office of the General Counsel.