Department of Health and Human Services 2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) 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 the information collection provisions of FDA's consultation procedures for foods derived from new plant varieties, including the information collection provisions in the guidance entitled, ``Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation),'' which developers may use to prepare the final consultation in a standard format.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of the Susceptibility Test Interpretive Criteria Website. The Susceptibility Test Interpretive Criteria Website will help to efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health and may allow for more efficient development and evaluation of antimicrobial susceptibility test (AST) devices. These changes may lead to better patient care and reduce antimicrobial resistance through improved antibiotic stewardship. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).

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 the proposed extension of the existing information Message Testing for Tobacco Communication Activities (MTTCA). CDC's Office on Smoking and Health has used the MTTCA clearance to support the development and testing of tobacco-related health messages, including messages supporting CDC's National Tobacco Education Campaign (NTEC) called the Tips from Former Smokers[supreg] campaign.

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 the National Vital Statistics Report Forms. These are the data collection forms used by State and/or county vital registration offices to report to the Federal government (a) provisional counts of births, deaths, and infant deaths at the end of each month and (b) annual counts of marriages and divorces/ annulments in support of the National Vital Statistics System. This submission contains no changes to the actual data collection forms. However, the number of respondent for the monthly and annual forms have shifted from 91 and 58 respectively to 58 and 91, since the 33 New Mexico Counties only send marriage and divorce information that is now only captured in the annual report.

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.

This notice announces a 1-year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. The extension of this model is applicable to the following states and the District of Columbia: Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held on January 24, 2018, of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The meeting will be open to the public; a public comment session will be held during the meeting. Pre- registration is required for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to CARB@hhs.gov. Registration information is available on the website https://www.hhs.gov/ash/carb/ and must be completed by January 15, 2018; all in-person attendees must pre-register by this date. Additional information about registering for the meeting and providing public comment can be obtained at https:// www.hhs.gov/ash/carb/ on the Meetings page.

The Food and Drug Administration (FDA or the Agency) is announcing the website location where the Agency will post two lists of guidance documents that CDRH (or the Center) intends to publish in fiscal year (FY) 2018. In addition, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders. This feedback is critical to the CDRH guidance program to ensure that we meet stakeholder needs.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Refusal of Inspection by a Foreign Food Establishment or Foreign Government.'' This draft guidance, when finalized, will provide information for foreign food establishments subject to our inspection, as well as foreign governments, on when we may consider that a foreign food establishment or a government of a foreign country has refused to permit an inspection by us as provided in the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA or Agency) 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 information collection provisions for calorie labeling of articles of food in vending machines.

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.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the availability of stored sera, plasma, and urine samples obtained from participants in the National Health and Nutrition Examination Survey (NHANES) for use and the fee schedule for such use. The National Health and Nutrition Examination Survey (NHANES) is one of a series of health- related surveys conducted by CDC's National Center for Health Statistics (NCHS).

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

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.

OHS invites public comment on several specific changes being considered for the CLASS condition of the Designation Renewal System (DRS) as outlined in the Head Start Program Performance Standards. We are considering changes to the CLASS condition with a goal of improving implementation and transparency of the DRS. Changes being considered include removal of the ``lowest 10 percent'' provision of the CLASS condition, an increase of the minimum thresholds for the Emotional Support and Classroom Organization domains to a score of 5, removal of the minimum threshold for the Instructional Support domain, and establishment of authority for the Secretary to set an absolute minimum threshold for the Instructional Support domain prior to the start of each fiscal year to be applied for DRS CLASS reviews in the same fiscal year. OHS requests feedback on these possible changes as well as alternative changes to the CLASS condition, particularly ways the Instructional Support threshold could be set and/or adjusted that would incentivize program improvement while acknowledging the current state of the field. OHS also invites feedback on other conditions of the DRS.

Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the Food and Drug Administration (FDA or Agency) is required to report annually in the Federal Register on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct.