Department of Health and Human Services February 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Attachment to Guidance on Antiviral Product DevelopmentConducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data.'' The purpose of this guidance is to assist sponsors in submitting human immunodeficiency virus (HIV) clinical virology data that are important for supporting clinical trials of products in development for the treatment of HIV. HIV resistance data submitted in appropriately formatted datasets are critical components in the review of investigational antiviral products for the treatment of HIV. The information in this guidance will facilitate the development of anti- HIV products. This draft guidance revises the guidance for industry entitled ``Attachment to Guidance on Antiviral Product Development Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV Resistance Data'' issued on June 5, 2006.

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 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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) The accuracy of the estimated burden; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) 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 that a collection of information entitled ``Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of 69 new animal drug applications (NADAs) and 22 abbreviated new animal drug applications (ANADAs) for use of arsanilic acid, carbarsone, or roxarsone Type A medicated articles to manufacture combination drug Type B and Type C medicated feeds. This action is being taken at the sponsor's request because the products are no longer manufactured or marketed. FDA is also amending the animal drug regulations to remove entries describing conditions of use for combination drug medicated feeds for which no NADA is approved. This action is being taken to improve the accuracy of the regulations.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during December 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of an NADA and a change to a sponsor's address.

Under the provisions of Section 3507(a)(1)(D) of 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. This proposed information collection was previously published in the Federal Register on August 2, 2013, page 46994 and allowed 60-days for public comment. One public comment was received regarding human subjects research recruitment and retention and the perception of coercion. The recruitment and enrollment procedures proposed by a NIMH-funded clinical trial are reviewed and approved by an IRB of record, which has agreed to review human subject research projects in accordance with 45 CFR Part 46 and its Federal-wide Assurance. The IRB of record ensures that the possibility of coercion or undue influence is minimized, that an investigator seeks consent only under circumstances that provide the prospective subject/representative sufficient opportunity to consider whether or not to participate. To address these concerns, we plan to add a statement about human subject protections to the policy and add a link to the human subjects training on the policy Web page. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health (NIMH), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2013.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies,'' dated March 2014. This draft guidance informs members of the medical and scientific community and other interested persons that we intend to exercise enforcement discretion regarding the investigational new drug (IND) requirements for the use of fecal microbiota for transplantation (FMT) to treat C. difficile infection not responding to standard therapies, provided the licensed health care provider treating the patient obtains adequate informed consent from the patient or his or her legally authorized representative for use of the FMT products, the stool is obtained from a donor known to either the patient or the licensed health care provider treating the patient, and the donor and stool are qualified by screening and testing performed under the direction of the licensed health care provider for the purpose of providing the FMT product to treat his or her patient. This draft guidance, when finalized, is intended to supersede the guidance document entitled ``Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies,'' dated July 2013 (July 2013 Guidance).

This advance notice of proposed rulemaking (ANPRM) solicits public comments on different methodologies we may consider using with regard to applying information from the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding programs to adjust Medicare fee schedule payment amounts or other Medicare payment amounts for DMEPOS items and services furnished in areas that are not included in these competitive bidding programs. In addition, we are also requesting comments on a different matter regarding ideas for potentially changing the payment methodologies used under the competitive bidding programs for certain durable medical equipment and enteral nutrition.

This notice of proposed rulemaking introduces the beginning of the Office of National Coordinator for Health Information Technology's (ONC's) more frequent approach to health information technology certification regulations. Under this approach ONC intends to update certification criteria editions every 12 to 18 months in order to provide smaller, more incremental regulatory changes and policy proposals. This approach gives stakeholders greater and earlier visibility into our regulatory direction before compliance is required, provides more time for public input on policy proposals under consideration for future rulemakings, and enables our certification processes to more quickly adopt newer industry standards that can enhance interoperability. The 2015 Edition EHR certification criteria proposed in this rule would be voluntary. No EHR technology developer who has certified its EHR technology to the 2014 Edition would need to recertify to the 2015 Edition in order for its customers to participate in the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs). Furthermore, eligible professionals, eligible hospitals, and critical access hospitals that participate in the EHR Incentive Programs would not need to ``upgrade'' to EHR technology certified to 2015 Edition in order to have EHR technology that meets the Certified EHR Technology (CEHRT) definition. Instead, the 2015 Edition EHR certification criteria would accomplish three policy objectives: 1) They would enable a more efficient and effective response to stakeholder feedback; 2) they would incorporate ``bug fixes'' to improve on 2014 Edition EHR certification criteria in ways designed to make our rules clearer and easier to implement; and 3) they reference newer standards and implementation specifications that reflect our commitment to promoting innovation and enhancing interoperability. Specific revisions to the ONC HIT Certification Program are also included in this proposed rule. These proposals focus on: Improving regulatory clarity; simplifying the certification of EHR Modules that are designed for purposes other than achieving meaningful use; and discontinuing the use of the Complete EHR definition starting with the 2015 Edition.