Department of Health and Human Services April 6, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Science Board to the Food and Drug Administration. The Science Board provides advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board advises the Agency on keeping pace with technical and scientific developments, including in regulatory science; provides input into the Agency's research agenda; and advises on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. The meeting will be open to the public.

The Agency for Healthcare Research and Quality (AHRQ) announces the Special Emphasis Panel (SEP) meeting on Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute Learning Health Systems Mentored Career Development Program (K12). Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public; however, visitors must be processed in accordance with established federal policies and procedures. Attendance is limited only by room seating available, (add number of seats that will be available in the room). The public is also welcome to listen to the meeting via teleconference; 100 teleconference lines are available. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt of written public comment is May 3, 2018. All requests must contain the name, address, and organizational affiliation of the speaker, as well as the topic being addressed. Written comments should not exceed one single-spaced typed page in length and delivered in 3 minutes or less. Members of the public who wish to provide public comments should plan to attend the public comment session at the start time listed. Please note that the public comment period may end before the time indicated, following the last call for comments. Written comments received in advance of the meeting will be included in the official record of the meeting. Registration is required to attend in person or on the phone. Interested parties may register at www.cdc.gov/ hicpac.

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACIP. The ACIP consists of 15 experts in fields associated with immunization practices and public health, have expertise in the use of vaccines and other immunobiologic agents in clinical practice or preventive medicine, have expertise with clinical or laboratory vaccine research, or have expertise in assessment of vaccine efficacy and safety. The committee shall include a person or persons knowledgeable about consumer perspectives and/or social and community aspects of immunization programs. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of vaccines and related agents for effective control of vaccine-preventable diseases in the civilian population of the United States. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of ACIP objectives https://www.cdc.gov/vaccines/acip/committee/charter.html.

The Prescription Drug User Fee Act of 2017 (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA, highlights the goal of advancing model-informed drug development (MIDD). Exposure-response analysis is a MIDD strategy that has been used in drug development and regulatory decision making. The Food and Drug Administration (FDA or Agency) is opening a docket to receive public comments on experience leveraging exposure-response analysis since publishing the guidance for industry (GFI) entitled ``Exposure-Response RelationshipsStudy Design, Data Analysis, and Regulatory Applications,'' which was announced in the Federal Register on May 6, 2003. Specifically, the Agency wants to identify areas of scientific policy that may need further clarity or elaboration, as well as any obstacles that prevent use of exposure-response analyses in drug development and regulatory review.

HRSA is requesting nominations to fill vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by Title XXI of the Public Health Service Act (the Act), and advises the Secretary of HHS (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).

The Agency for Healthcare Research and Quality (AHRQ) announces the Special Emphasis Panel (SEP) meeting on AHRQ-HS-17-012, Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute Learning Health Systems Mentored Career Development Program (K12). Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.