Department of Health and Human Services March 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry describing the Agency's current thinking on how to determine the number of employees for purposes of the ``small business'' definition in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for human and animal food rules. The draft guidance, when finalized, will help industry subject to those rules determine the number of employees for purposes of the ``small business'' definition.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). This meeting was announced in the Federal Register of January 23, 2018. The amendment is being made to reflect a change in the agenda for the open session of the meeting and to extend the amount of time allotted for the closed session. There are no other changes.

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.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, Office of Policy and Extramural Research Administration (OPERA), Office of Extramural Research (OER), Office of the Director (OD) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to delay the effective date of amendments to the existing medical product ``intended use'' regulations, contained in the final rule published January 9, 2017, until further notice. This final rule delays the effective date of the amendments to allow further consideration of the substantive issues raised in the comments received regarding the amendments. This action does not delay the effective date of the portions of the January 9, 2017, final rule that describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which remains March 19, 2018.

The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes. Because tobacco-related harms ultimately result from addiction to the nicotine in such products, causing repeated use and exposure to toxicants, FDA is considering taking this action to reduce the level of nicotine in these products so they are minimally addictive or nonaddictive, using the best available science to determine a level that is appropriate for the protection of the public health. FDA is using the term ``nonaddictive'' in this document specifically in the context of a potentially nonaddictive cigarette. We acknowledge the highly addictive potential of nicotine itself depending upon the route of delivery. As discussed elsewhere in this document, questions remain with respect to the precise level of nicotine in cigarettes that might render them either minimally addictive or nonaddictive for specific members or segments of the population. We envision the potential circumstance where nicotine levels in cigarettes do not spur or sustain addiction for some portion of potential smokers. This could give addicted users the choice and ability to quit more easily, and it could help to prevent experimenters (mainly youth) from initiating regular use and becoming regular smokers. The scope of products covered by any potential product standard will be one issue for comment in the ANPRM. Any additional scientific data and research relevant to the empirical basis for regulatory decisions related to a nicotine tobacco product standard is another issue for comment in the ANPRM.

The Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Brainvivo Ltd. (Brainvivo), located in Tel Aviv, Israel, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.

Under the National Childhood Vaccine Injury Act (NCVIA), CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On October 18, 2016, CDC published a notice in the Federal Register seeking public comments on proposed updated vaccine information materials for MMR vaccine and MMRV vaccine. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials. Copies of the final vaccine information materials for MMR and MMRV vaccine are available to download from https://www.cdc.gov/vaccines/hcp/vis/ or https:// www.regulations.gov (see Docket Number CDC-2016-0094).

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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 U.S. Department of Health and Human Services (HHS) is soliciting nominations of individuals who are interested in being considered a voting member for appointment to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). Nominations from qualified individuals who wish to be considered for appointment to this member category of the Advisory Council are currently being accepted.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Ames Laboratory in Ames, Iowa, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

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 comments on the proposed revision of the information collection titled ``The Enhanced STD surveillance Network (SSuN),'' which is the only source for enhanced and sentinel sexually transmitted disease (STD) surveillance data in the United States that: (1) Serves to strengthen national and local surveillance capacity; (2) collects information on populations at risk for STDs attending healthcare facilities; and (3) provides more accurate estimates of the burden of disease, incidence of disease, trends and impact of STDs at the population level.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Health Care Professional Survey of Professional Prescription Drug Promotion.'' This study will examine how health care professionals experience and perceive prescription drug promotion directed to them.