Department of Health and Human Services February 21, 2019 – Federal Register Recent Federal Regulation Documents

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry and investigators entitled ``Use of Investigational Tobacco Products.'' The revised draft guidance replaces the draft guidance of the same title announced in the Federal Register of September 24, 2015 (September 2015 draft guidance). The revised draft guidance, when finalized, will describe FDA's current thinking regarding the definition of ``investigational tobacco product'' and will discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations governing the use of investigational tobacco products become effective or FDA provides written notice of its intent to change its enforcement policy.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS 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.

In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL) has scheduled public meetings for the 2019 calendar year. Information about the ACICBL, agendas, and materials for these meetings can be found on the ACICBL website at https://www.hrsa.gov/advisory-committees/interdisciplinary-co mmunity- linkages/.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Preventive Health and Health Services Block Grant Center for State, Tribal, Local and Territorial Support (CSTLTS), Centers for Disease Control and Prevention (CDC). This study will allow CDC to monitor awardees progress, identify activities and personnel supported with Block Grant funding, conduct compliance reviews of Block Grant awardees, and promote the use of evidence-based guidelines and interventions.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces reopening of the National Center for Health Statistics' (NCHS) National Health and Nutrition Examination Survey (NHANES) DNA Specimen Repository for research proposals. Blood samples for DNA purification were collected from study participants, with their permission, during NHANES III (1991-1994), NHANES 1999-2000, NHANES 2001-02, NHANES 2007- 08, NHANES 2009-10, and NHANES 2011-12 (Office of Management and Budget Control Numbers # 0920-0237/0920-0950). DNA samples are being made available to the research community for genetic testing. The information gained from research using these samples can be combined with the extensive amount of information available in NHANES which describes the prevalence/trends of disease, nutrition, risk behaviors, and environmental exposures in the US population. A more complete description of this program follows.