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

The Food and Drug Administration (FDA) has determined the regulatory review period for Arctic Front Cryocatheter System 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 Patents and Trademarks, Department of Commerce, for the extension of patents which claim that medical device.

The Food and Drug Administration (FDA) has determined the regulatory review period for ZUPREVO 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 animal drug product.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological ProductsRecommended Practices.'' This guidance describes FDA's current thinking on recommended practices for drug manufacturers and their representatives to follow when distributing to health care professionals or health care entities scientific or medical journal articles that discuss new risk information for approved prescription drugs for human use, including drugs licensed as biological products, and approved animal drugs. The recommendations in this draft guidance are intended to address issues specific to the distribution of new information about risks associated with a drug that further characterizes risks identified in the approved labeling.

The Food and Drug Administration (FDA) has determined the regulatory review period for VANDETANIB 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) 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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). The draft guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and terminating notifications regarding illegitimate product. This draft guidance identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain; provides recommendations on how trading partners can identify the product and determine whether the product is a suspect product as soon as practicable; and for product that has been determined to be illegitimate, or (for manufacturers) has a high risk of illegitimacy, sets forth the process by which trading partners should notify FDA of illegitimate product and how they must terminate the notifications, in consultation with FDA.

The Food and Drug Administration (FDA or we) is confirming the effective date of May 13, 2014, for the final rule that appeared in the Federal Register of April 11, 2014, and that amended the color additive regulations to expand the permitted use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis) as a color additive in food.

The notice announces a meeting to peer review the Draft Report on Carcinogens (RoC) Monograph on Trichloroethylene (TCE). This document was prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS). The peer-review 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 are available at https:// ntp.niehs.nih.gov/go/38853.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Submissions in Electronic FormatPostmarketing Safety Reports.'' This draft guidance provides general information pertaining to electronic submission of postmarketing safety reports (individual case safety reports (ICSRs), attachments to ICSRs (ICSR attachments), and other postmarketing safety reports) for certain human drug and biological products. We are issuing the draft guidance to help persons required to submit postmarketing safety reports comply with the final rule.

The Food and Drug Administration (FDA) has determined the regulatory review period for STENDRA 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 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 solicits comments on information collection requirements for humanitarian use devices (HUDs).

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance which describes our current thinking on the quality factor requirements for eligible infant formulas, the record requirements for eligible infant formulas, and the submission of citizen petitions for eligible infant formulas.

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 March 18, 2014, Vol. 79, page 15133 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), 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 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.

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 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 to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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 in writing, request more information on the proposed project, or to obtain a copy of the data collection plans and instruments, contact Elizabeth M. Ginexi, Ph.D., Tobacco Control Research Branch, Behavioral Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, 9609 Medical Center Drive, Room 3E564 MSC 9761, Bethesda, Maryland 20892- 9761 or call non-toll-free number 240-276-6765 or Email your request, including your address to: LGinexi@mail.nih.gov. 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: State and Community Tobacco Control Research Initiative Evaluation (SCTC), 0925, NEW submission, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The National Cancer Institute State and Community Tobacco Control Research Initiative is a program within the Tobacco Control Research Branch in the Behavioral Research Program of the Division of Cancer Control and Population Sciences. The program targets 4 high-priority tobacco control research areas at the state and community level in the United States: (1) Secondhand smoke policies, (2) Tobacco tax and pricing policies, (3) Mass media countermeasures and community and social norms, and (4) Tobacco industry practices. The initiative supports innovative research to yield rapid and actionable findings for state and community tobacco control programs. The purpose of the evaluation is to assess the dissemination, implementation, and community collaboration processes of the grantees and their respective state and community partners and stakeholders. The evaluation will utilize archival grant project data and archival data collected from the scientists in the first two years of the initiative. The evaluation also will collect new data to: (1) Determine relationships, interactions, and connectedness among different network partnerships over time and with policy makers; (2) assess the utility of research tools, interventions, products, and findings from the perspective of key tobacco control stakeholders; and (3) determine key indicators for broad adoption of research products. Results will address research-to-practice gaps by providing a critical window into the process of disseminating evidence-based research tools, products, and science findings in community public health settings. Intended audiences include staff at NIH Institutes and Centers interested in supporting translation/dissemination and implementation science. OMB approval is requested for one year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 112.

The Food and Drug Administration (FDA) is confirming the effective date of June 18, 2014, for the direct final rule that appeared in the Federal Register of February 3, 2014. The direct final rule revises the regulations to update the table to adjust the preceding maximum civil penalty amounts for inflation as prescribed by the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA). The direct final rule also revises the regulations to amend the process for initiating certain civil money penalty (CMP) administrative actions. This document confirms the effective date of the direct final rule.

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. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA or we) 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 reporting requirements contained in existing FDA regulations governing temporary marketing permit applications.

The Food and Drug Administration (FDA or Agency) is issuing a regulation to establish a list of ``qualifying pathogens'' that have the potential to pose a serious threat to public health. This final rule implements a provision of the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and Innovation Act (FDASIA). GAIN is intended to encourage development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections, and provides incentives such as eligibility for designation as a fast-track product and an additional 5 years of exclusivity to be added to certain exclusivity periods. Based on analyses conducted both in the proposed rule and in response to comments to the proposed rule, FDA has determined that the following pathogens comprise the list of ``qualifying pathogens:'' Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Coccidioides species, Cryptococcus species, Enterobacteriaceae (e.g., Klebsiella pneumoniae), Enterococcus species, Helicobacter pylori, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, N. meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Vibrio cholerae. The preamble to the proposed rule described the factors the Agency considered and the methodology used to develop the list of qualifying pathogens. As described in the preamble of this final rule, FDA applied those factors and that methodology to additional pathogens suggested via comments on the proposed rule.

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.

HRSA will be issuing a 1-year non-competitive continuation budget period beyond the planned 3-year project period for the Autism Intervention Research Network on Behavioral Health (AIR-B Network) and the Autism Intervention Research Network on Physical Health (AIR-P Network) programs. Approximately $1,500,000 in funding will be made available in the form of a cooperative agreement to the University of California Los Angeles (UCLA), Cooperative Agreement Number UA3MC11055, during the budget period of September 1, 2014, through August 31, 2015. Approximately $3,000,000 in funding will be made available in the form of a cooperative agreement to the Massachusetts General Hospital (MGH), Cooperative Agreement Number UA3MC11054, during the budget period of September 1, 2014, through August 31, 2015. The AIR-B Network (UA3MC 11055) and the AIR-P Network (UA3MC11054) programs, CFDA No. 93.110, are authorized by the Public Health Service Act, Sec. 399BB(f) (42 U.S.C. 280i-1(f)), as amended by the Combating Autism Reauthorization Act of 2011 (Pub. L. 112-32), which is scheduled to sunset on September 30, 2014. The AIR-B Network is an interdisciplinary, multi-site network of researchers working together with communities to provide national leadership in research to improve the behavioral, mental, social, and/ or cognitive health and wellbeing of children and adolescents with autism spectrum disorders (ASD) and other developmental disabilities. The AIR-B Network conducts protocol-based research to advance effective intervention strategies aimed at improving social and behavioral health and well-being among underserved children and adolescents with ASD, in both home and school settings; provides a research environment that is supportive of the professional development of emerging researchers interested in autism intervention research; disseminates critical information on its research findings to inform researchers, care providers, policymakers, other stakeholders in the field, and the public, including families with children and adolescents with ASD; and promotes the translation of network findings into practice settings and communities that will result in improved care. The AIR-P Network is an interdisciplinary, multi-site research network of clinicians and researchers that provides national leadership in research to improve the physical health and well-being of children and adolescents with autism spectrum disorders (ASD) and other developmental disabilities. The AIR-P Network conducts protocol-based research to advance effective treatment strategies; develops and updates evidence-based guidelines and validates tools for interventions; provides a research environment that supports the professional development of emerging researchers interested in autism intervention research; disseminates critical information on its research findings to inform researchers, care providers, policymakers, other stakeholders in the field, and the public, including families with children and adolescents with ASD; and promotes the translation of findings into practice settings and communities that will result in improved care.

HRSA will be issuing non-competitive awards under the F2F HIC program. Approximately $5 million will be made available in the form of a grant to current grantees (see below) covering the period of 6/1/ 2014-5/31/2015. This will provide for an extension of the program, as provided for in Section 1203 of the Pathway for SGR Reform Act of 2013 (Pub. L. 113-67) and Section 207 of the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93) with the least disruption to the states, communities, and constituencies that currently receive assistance and services from these grantees.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, AHRQ has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA).

The U.S. Department of Health and Human Services (HHS) published a direct final rule in the Federal Register on April 14, 2014, that would have adopted requirements on the use of HHS's official logo and seal. HHS stated in the direct final rule that if it received a significant adverse comment, HHS would publish a notice of withdrawal. HHS received two comments and considers at least one of these comments a significant adverse comment. The direct final rule was not withdrawn prior to its effective date. As a result, HHS is now publishing this removal of the direct final rule.

The Food and Drug Administration (FDA or we) 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 information collection provisions of FDA's third party disclosure and recordkeeping requirements for reportable food.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements'' 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 announcing that a collection of information entitled ``Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables'' 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 announcing that a collection of information entitled ``Pet Event Tracking Network (PETNet)State, Federal Cooperation to Prevent Spread of Pet Food Related Diseases'' 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 announcing the availability of a revised draft guidance for industry entitled ``Product Development Under the Animal Rule.'' When human efficacy studies are neither ethical nor feasible, FDA may rely on adequate and well-controlled animal efficacy studies to support approval of a drug or licensure of a biological product under the Animal Rule. This revised draft guidance replaces the 2009 draft guidance for industry entitled ``Animal ModelsEssential Elements to Address Efficacy Under the Animal Rule'' and addresses a broader scope of issues for products developed under the Animal Rule. Once finalized, this guidance is intended to help potential sponsors (industry, academia, and government) understand FDA's expectations for product development under the Animal Rule.

The Food and Drug Administration (FDA or we) is announcing the availability of Compliance Policy Guide Sec. 100.250 Food Facility RegistrationHuman and Animal Food (the CPG). The CPG provides guidance for our staff on enforcement of food facility registration requirements.

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.

The Food and Drug Administration (FDA or the Agency) is reclassifying ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and renaming them sunlamp products and UV lamps intended for use in sunlamp products. FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.