Department of Health and Human Services September 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Qualification of BiomarkerPlasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary Disease.'' This guidance provides a qualified context of use (COU) for plasma fibrinogen in interventional clinical trials of chronic obstructive pulmonary disease (COPD) subjects at high risk for exacerbations and/or all-cause mortality. This guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program. This biomarker can be used by drug developers for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.

This action removes the outmoded regulations for the Smallpox Vaccine Injury Compensation Program. The program and its implementing regulation have been rendered obsolete by the expiration of the Declaration Regarding Administration of Smallpox Countermeasures under the Smallpox Emergency Personnel Protection Act of 2003 and incorporation of the smallpox countermeasure injury coverage under the Public Readiness and Emergency Preparedness Act of 2005 and its authorization of the Countermeasures Injury Compensation Program.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the withdrawal of the notice published under the same title on August 25, 2016 for public comment.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``510(k) Third Party Review Program.'' This draft guidance provides a comprehensive look into FDA's current thinking regarding the 510(k) Third Party (TP) Review Program authorized under section 523 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In an effort to encourage harmonization, this guidance proposes to refer to, for the purpose of the TP Review Program, where appropriate and consistent with the FD&C Act and other applicable laws and regulations, the elements from the International Medical Device Regulators Forum's regulatory assessment program called the Medical Device Single Audit Program. In addition, the Food and Drug Administration Safety and Innovation Act (FDASIA) requires FDA to establish and publish in the Federal Register criteria to reaccredit and deny reaccreditation of TP Review Organizations. Those criteria, including others, are described in this draft guidance. This draft guidance is not final nor is it in effect at this time.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling.'' The draft guidance, when finalized, will describe the type and quality of evidence that we recommend that infant formula manufacturers and distributors have to substantiate structure/function claims in infant formula labels and labeling. This draft guidance is intended to help infant formula manufacturers making structure/function claims comply with the statutory requirement that all claims in infant formula labeling must be truthful and not misleading under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``E17 General Principles for Planning and Design of Multi-Regional Clinical Trials.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance describes general principles for planning and designing multi-regional clinical trials (MRCT). MRCTs conducted according to the guidance will investigate treatment effects in overall populations with multiple ethnic factors (intrinsic and extrinsic factors as described in the ICH guidance entitled ``E5 Ethnic Factors in the Acceptability of Foreign Clinical Data'' (E5 guidance)) and evaluate the consistency of treatment effects across populations. The draft guidance is intended to increase the acceptability of data from MRCTs as the primary source of evidence supporting marketing approval in global regulatory submissions and to thereby facilitate more efficient drug development and earlier access to medicines.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Health and Human Services Department (HHS) is correcting a final rule that appeared in the Federal Register on July 8, 2016. The final rule increased the maximum number of patients to whom an individual practitioner may dispense or prescribe certain medications, including buprenorphine, from 100 to 275. Practitioners are eligible for the increased patient limit if they have prescribed covered medications to up to 100 patients for at least one year pursuant to secretarial approval, provided that they meet certain criteria and adhere to several additional requirements aimed at ensuring that patients receive the full array of services that comprise evidence- based medication-assisted treatment (MAT) and minimize the risks that medications provided for treatment are misused or diverted. One pathway through which practitioners may become eligible to increase their patient limit is by obtaining additional credentialing from one of several credentialing bodies. In the final rule, the name of one of the credentialing bodies listed was incorrect. This action provides the correct name.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts 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 requires by the Paperwork Reduction Act of 1995. This notice invites comments on Early Hearing Detection and Intervention Pediatric Audiology Links to Services (EDHI- PALS)

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), 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 March 15, 2016, CDC published a notice in the Federal Register (81 FR 13794) seeking public comments on proposed updated vaccine information materials for polio vaccine and varicella vaccine. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for polio vaccine. Copies of the final vaccine information materials for polio vaccine are available to download from https:// www.cdc.gov/vaccines/hcp/vis/ or https://www.regulations.gov (see Docket Number CDC-2015-0029). CDC will publish the final vaccine information materials for varicella vaccine when they are completed.