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

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.'' The draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. The draft guidance provides the Agency's recommendations and requirements for informed consent to assure the protection of the rights and welfare of human subjects in clinical investigations.

The Food and Drug Administration (FDA or we) is correcting a final rule that appeared in the Federal Register of June 10, 2014. The final rule revised our infant formula regulations by establishing requirements for current good manufacturing practices, including audits; establishing requirements for quality factors; and amending our quality control procedures, notification, and record and reporting requirements for infant formula. We issued the final rule to provide greater protection of infants who consume infant formula products. In this document, we correct some errors that appeared in the preamble to the final rule.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments And For Further Information: To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, contact: Brenda Kostelecky, Center for Global Health, National Cancer Institute, 9609 Medical Center Dr., RM 3W276, Rockville MD, 20850 or call non-toll-free number 240-276-5585 or Email your request, including your address to: brenda.kostelecky@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Evaluation of Cancer Control Leadership Forums at the Center for Global Health (CGH) (NCI), 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This submission is a request for OMB to approve the Cancer Control Leadership Forums. These workshops are organized and funded by the National Cancer Institute's CGH in conjunction with various partners ranging from foreign Ministries of Health and research institutions, to international non- governmental organizations (NGOs) and U.S. academic institutions. The goal of the U.S. National Cancer Institute (NCI) Cancer Control Leadership Forums is to increase the capacity of participating countries to initiate or enhance cancer control planning and implementation in their respective countries. The Forums are an opportunity for countries to exchange experiences and ideas about creating and implementing comprehensive cancer control plans. The proposed evaluation requests information about the outcomes of the forums including (1) status of cancer control planning and implementation in each participating country, (2) outcomes related to the action plans (e.g. developing written materials, completion of action items, resources and support acquired),(3) successes and challenges related to the action plans, and (4) new cancer control partnerships and networks. Baseline information regarding the status of cancer control planning and implementation will be collected 3 months prior to the Forums in order to inform the development of each Forum. The evaluation information will be collected 3-24 months after each forum and is needed to evaluate the effectiveness of these workshops in order to inform future programming and funding decisions. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 108.

This notice announces a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. The meeting is open to the public. Registration is requested for both public attendance and oral comment and required to access the webcast. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/32822.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Rebecca A. Ferrer, Division of Cancer Control and Population Sciences, 9609 Medical Center Dr., Room 3E114, Bethesda, MD 20892 or call non-toll- free number 240-276-6914 or Email your request, including your address to: ferrerra@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice invites comments on the Health and Diet Survey as used by FDA to gauge and to track consumer attitudes, awareness, knowledge, and behavior regarding various topics related to health, nutrition, physical activity, and product labeling.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive evaluation option license to practice the inventions embodied in U.S. Provisional Application 61/094,318 filed September 4, 2008 entitled ``Method for detection of cancer based on spatial genome organization'' (HHS Ref No. E-283-2008/0-US-01); International Application PCT/US2009/055857 filed September 3, 2009 entitled ``Method for detection of cancer based on spatial genome organization'' (HHS Ref No. E-283-2008/0-PCT-02); U.S. Patent Application 13/062,247 filed March 4, 2011 entitled ``Method for detection of cancer based on spatial genome organization'' (HHS Ref No. E-283-2008/0-US-0; and foreign equivalents thereof to Radial Genomics, Ltd. (``RG''), a company located in Cambridge, U.K. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive evaluation option license territory may be worldwide and the field of use may be limited to the use of the Licensed Patent Rights for the diagnosis, prognosis, and prediction of cancer. Upon the expiration or termination of the exclusive evaluation option license, RG will have the exclusive right to execute an exclusive commercialization license which will supersede and replace the exclusive evaluation option license with no greater field of use and territory than granted in the exclusive evaluation option license.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Heragen, Inc., which is located in Benicia, California to practice the inventions embodied in the following patent applications:

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 (PRA).

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

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDA SubmissionsAmendments and Easily Correctable Deficiencies Under GDUFA.'' The guidance document is intended to assist applicants in preparing to submit to FDA amendments to abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), by explaining how the Generic Drug User Fee Amendments of 2012 (GDUFA) performance metric goals apply to these submissions. When finalized, this guidance will replace the December 2001 guidance for industry entitled ``Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications'' in consideration of the new amendment review tier system and performance goals under GDUFA.

This Special Fraud Alert addresses compensation paid by laboratories to referring physicians and physician group practices (collectively, physicians) for blood specimen collection, processing, and packaging, and for submitting patient data to a registry or database. OIG has issued a number of guidance documents and advisory opinions addressing the general subject of remuneration offered and paid by laboratories to referring physicians, including the 1994 Special Fraud Alert on Arrangements for the Provision of Clinical Laboratory Services, the OIG Compliance Program Guidance for Clinical Laboratories, and Advisory Opinion 05-08. In these and other documents, we have repeatedly emphasized that providing free or below-market goods or services to a physician who is a source of referrals, or paying such a physician more than fair market value for his or her services, could constitute illegal remuneration under the anti-kickback statute. This Special Fraud Alert supplements these prior guidance documents and advisory opinions and describes two specific trends OIG has identified involving transfers of value from laboratories to physicians that we believe present a substantial risk of fraud and abuse under the anti- kickback statute.

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 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.

This rule proposes to update and make revisions to the End- Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2015. This rule also proposes to set forth requirements for the ESRD quality incentive program (QIP), including payment years (PYs) 2017 and 2018. This rule also proposes to make a technical correction to remove outdated terms and definitions. In addition, this rule proposes to set forth the methodology for adjusting Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) fee schedule payment amounts using information from the Medicare DMEPOS Competitive Bidding Program (CBP); make alternative payment rules for DME and enteral nutrition under the Medicare DMEPOS CBP; clarify the statutory Medicare hearing aid coverage exclusion and specify devices not subject to the hearing aid exclusion; update the definition of minimal self-adjustment regarding what specialized training is needed by suppliers to provide custom fitting services if they are not certified orthotists; clarify the Change of Ownership (CHOW) and provides for an exception to the current requirements; revise the appeal provisions for termination of a contract and notification to beneficiaries under the Medicare DMEPOS CBP, and add a technical change related to submitting bids for infusion drugs under the Medicare DMEPOS CBP.

The National Vaccine Program Office (NVPO), a program office within the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is extending the solicitation period for nominations of qualified candidates to be considered for appointment as public members to the National Vaccine Advisory Committee (NVAC). NVPO is taking this action to allow more time for qualified candidates to be identified to be considered for appointment as public members of the NVAC. NVPO is seeking additional candidates that meet the expertise and qualifications needed to constitute a balanced membership as outlined in the Committee's charter and to ensure that the membership will be fairly balanced in terms of the points of view represented and the Committee's function. Management and support of the NVAC and its activities are the responsibility of the NVPO. The NVAC serves an advisory role, providing peer review, consultation, advice, and recommendations to the Assistant Secretary for Health, in his capacity as Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non- government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is publishing this issuance and enforcement guidance for dog confinement agreements under 42 CFR 71.51. Under 42 CFR 71.51(c)(2), the CDC Director may authorize admission into the United States of a dog that has not been vaccinated for rabies or that is inadequately immunized if the owner agrees to subsequently vaccinate and properly confine the dog. This guidance describes the factors that HHS/CDC will consider in determining whether it will issue a dog confinement agreement allowing entry of a dog that has not been adequately immunized against rabies, or whether the dog(s) will be denied entry. The notice also describes the steps that an importer may take if his/her imported dog is denied entry.