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

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 to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the National Health Interview Survey (NHIS). The annual National Health Interview Survey is a major source of general statistics on the health of the U.S. population.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Identifying Trading Partners Under the Drug Supply Chain Security Act'' (draft trading partner guidance). FDA is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). This guidance explains how to determine when certain statutory requirements will apply to entities that may be considered trading partners in the drug supply chain. FDA is also soliciting public input specific to the activities of ``private-label distributors'' of drug products and whether those activities fall within the definitions under DSCSA of the various trading partners.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RECUVYRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.

The Food and Drug Administration (FDA, the Agency, or we) is establishing a public docket to assist with its development of recommendations regarding the communication of risk information in direct-to-consumer (DTC) broadcast advertisements for prescription drugs and biologics.

The Department of Health and Human Services is hereby giving notice that the charter for the National Vaccine Advisory Committee (NVAC) has been renewed.

This notice announces the intention of the Agency for

The Centers for Disease Control and Prevention (CDC) in the

This proposed rule proposes to cancel the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) incentive payment model and to rescind the regulations governing these models. It also proposes to revise certain aspects of the Comprehensive Care for Joint Replacement (CJR) model, including: Giving certain hospitals selected for participation in the CJR model a one-time option to choose whether to continue their participation in the model; technical refinements and clarifications for certain payment, reconciliation and quality provisions; and a change to increase the pool of eligible clinicians that qualify as affiliated practitioners under the Advanced Alternative Payment Model (APM) track.

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 to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the information collection project titled ``Assessing Education Agency Staff Perceptions of School Climate and Youth Access to Services.'' This study provides in-depth assessment of HIV and STD prevention efforts in three local education agencies funded by CDC's Division of Adolescent and School Health.

A notice was published in the Federal Register on Monday, July 17, 2017 (Vol. 82, No. 135, pages 32711-32712), to solicit nominations of individuals who are interested in being considered for appointment to the Tick-Borne Disease Working Group (Working Group). The nomination period is scheduled to end close of business on August 16, 2017. The notice is being amended to extend the solicitation period for one week to allow more time for interested individuals to submit nominations.

The Food and Drug Administration (FDA or Agency) has determined that CORDARONE (amiodarone hydrochloride) tablets, 200 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Secretary of Health and Human Services (Secretary), in accordance with section 6031 of the 21st Century Cures Act, announces the inaugural meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The ISMICC will meet on August 31, 2017, from 9:00 a.m. to 5:00 p.m., Eastern Time. The meeting will be held at the Hubert H. Humphrey Building, 200 Independence Avenue SW., Room 800, Washington, DC 20201. The meeting will include information on federal advances related to serious mental illness (SMI) and serious emotional disturbance (SED), including data evaluation, and recommendations for action. Committee members will also discuss workgroups, future meetings, and the Report to Congress. Members of the public can attend the meeting via telephone or webcast. The meeting can be accessed via webcast at www.hhs.gov/live. To obtain the call-in number and access code, submit written or brief oral comments, or request special accommodations for persons with disabilities, please register at the SAMHSA Advisory Committees Web site at https://www.samhsa.gov/about-us/advisory-councils/smi-committ ee or contact Pamela Foote, Designated Federal Official (see contact information below). Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written statements should be submitted to the DFO on or before August 24, 2017. Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations are encouraged to notify the DFO on or before August 24, 2017. Two minutes will be allotted for each presentation. Substantive meeting information and a roster of Committee members is available at the Committee's Web site https://www.samhsa.gov/about- us/advisory-councils/smi-committee or by contacting Pamela Foote, DFO. Committee Name: Interdepartmental Serious Mental Illness Coordinating Committee Dates/Time/Type: August 31, 2017/9:00 a.m.5:00 p.m./OPEN Place: Hubert H. Humphrey Building, 200 Independence Avenue SW., Room 800, Washington, DC 20201. Webcast and teleconference (see information above). DFO: Pamela Foote, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, 14E53C, Rockville, MD 20857; telephone: 240-276-1279; email: pamela.foote@samhsa.hhs.gov

The Food and Drug Administration (FDA or Agency) is announcing the availability for public comment of a proposed method for applying a food animal biomass denominator to annual data on antimicrobials sold and distributed for use in food animals in the United States. This method will allow us to obtain a corrected estimate of antimicrobial drug sales relative to the animal population potentially being treated with those drugs, thereby lending further context to the antimicrobial sales data we are collecting and analyzing.

AIDD intends to reallot funds under authority of the Development Disabilities Assistance and Bill of Rights Act of 2000 which states: ``If the Secretary determines that an amount of an allotment to a State for a period (of a fiscal year or longer) will not be required by the State during the period for the purpose for which the allotment was made, the Secretary may reallot the amount.'' AIDD will be reallotting FY 2017 funds awarded to the State Council on Developmental Disabilities (SCDD) and the Protection & Advocacy (P&A) agency located within the Commonwealth of Puerto Rico. This determination is based on the limited reported expenditures and requests for reimbursement over the last several years from the SCDD and P&A in the Commonwealth of Puerto Rico. The Puerto Rico SCDD will have up to $1.9 million rescinded and proportionately redistributed to the remaining SCDDs. SCDDs that receive FY 2017 realloted funds will have through the end of FY 2018 to obligate the funds and until the end of FY 2019 to liquidate the funds. The Puerto Rico P&A will have up to $550,000 rescinded and proportionately redistributed to the remaining P&As. P&As that receive the FY 2017 funds will have through the end of FY 2019 to spend the funds. Realloted funds for both the SCDDs and the P&As must be used according to the terms as outlined in the FY 2017 Notice of Award for each program.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the aforementioned subcommittee. This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference at the USA toll-free, dial-in number at 1-866-659-0537 and the pass code is 9933701. The conference line has 150 ports for callers.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned committee. This meeting is open to the public. The public comment period is from 12:30 p.m. to 12:45 p.m. Please note that the public comment period ends at the time indicated above or following the last call for comments, whichever is earlier. Each commenter will be provided up to five minutes for comment. A limited number of time slots are available and will be assigned on a first come-first served basis. Written comments will also be accepted from those unable to attend the public session via an on-line form at the following Web site: https://www.cdc.gov/ niosh/bsc/contact.html. This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 33 people. The meeting is also open to the public via webcast. If you wish to attend in person or by webcast, please see the NIOSH Web site to register (https://www.cdc.gov/niosh/bsc/) or call (404-498-2539) at least five business days in advance of the meeting. Teleconference is available toll-free; please dial (888) 397-9578, Participant Pass Code 63257516. Adobe Connect webcast will be available at https:// odniosh.adobeconnect.com/nioshbsc/ for participants wanting to connect remotely.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products: Guidance for Industry.'' The guidance advises manufacturers who wish to use ultrafiltered milk (UF milk) or ultrafiltered nonfat milk (UF nonfat milk) in the production of standardized cheeses and related cheese products that, pending completion of a rulemaking regarding the use of UF milk in the production of these products, we intend to exercise enforcement discretion regarding the use of fluid UF milk and fluid UF nonfat milk in the production of standardized cheeses and related cheese products. We also intend to exercise enforcement discretion regarding the declaration of ingredients in the labeling of standardized cheeses and related cheese products when fluid UF milk and fluid UF nonfat milk are used as ingredients.