Department of Health and Human Services August 2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. 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 procedure by which a manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit information to us upon which it has based its conclusion that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe.

The Food and Drug Administration (FDA) is announcing the availability on the Agency Web site of revised final versions of the following four documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: ``The eCTD Backbone Files Specification for Module 1,'' version 2.2 (which includes the U.S. regional document type definition (DTD), version 3.2); ``The Comprehensive Table of Contents Headings and Hierarchy,'' version 2.2; ``Specifications for eCTD Validation Criteria,'' version 3.0; and ``Example Submissions using eCTD Backbone Files Specification for Module 1,'' version 1.2. Technical files that support these documents are also available on the Agency Web site. A complete summary of the revisions made is included in the updated documents. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.2 by June 2014, and will give 30 days' advance notice to industry.

The Food and Drug Administration (FDA) is withdrawing approval of four new animal drug applications (NADAs) held by Quali-Tech Products, Inc., at the sponsor's request because the products are no longer manufactured or marketed.

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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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 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: Ms. Sarah L. Glavin, Deputy Director, Office of Science Policy, Analysis and Communication, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Drive, Room 2A18, Bethesda, Maryland 20892, or call a non-toll free number (301) 496-7898 or Email your request, including your address to glavins@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments 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: The National Children's Study, Vanguard (Pilot) Study, 0925-0593, Expiration 8/31/2014Revision, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this request is to continue data collection activities for the NCS Vanguard Study and receive a renewal of the Vanguard Study clearance. The NCS also proposes the initiation of a new enrollment cohort, the addition of new Study visits, revisions to existing Study visits, and the initiation of methodological substudies. The NCS Vanguard Study is a prospective, longitudinal pilot study of child health and development that will inform the design of the Main Study of the National Children's Study. Background: The National Children's Study is a prospective, national longitudinal study of the interaction between environment, genetics on child health, and development. The Study defines ``environment'' broadly, taking a number of natural and man-made environmental, biological, genetic, and psychosocial factors into account. Findings from the Study will be made available as the research progresses, making potential benefits known to the public as soon as possible. The National Children's Study (NCS) has several components, including a pilot or Vanguard Study, and a Main Study to collect exposure and outcome data. The NCS Vanguard Study continues to follow the children and families enrolled in the Vanguard Study, conducting Study visits in participants' homes and over the telephone. Data Collection visits may include the administration of questionnaires, neurodevelopmental assessments, physical measures, and the collection of biospecimens and environmental measures. The Vanguard Study has yielded valuable data and field experience related to participant recruitment, the conduct of Study assessments, and operational requirements associated with NCS infrastructure and field efforts. The purpose of the proposed data collection is to obtain further operational and performance data on processes and administration Study visit measures. Research Questions: The primary research goal is to systematically pilot additional study visit measures and collections for scientific robustness, burden to participants and study infrastructure, and cost for use in the Vanguard (Pilot) Study and to inform the Main Study. A secondary goal is to increase enrollment in the Vanguard Study through the identification of subsequent pregnancies among enrolled women. Methods: The NCS Vanguard Study data collection schedule includes pre-pregnancy, pregnancy, and birth periods, as well as post-natal collection points at defined intervals between 3 and 60 months. We propose to add or modify the selected measures below to address analytic goals of assessing feasibility, acceptability, and cost of specific study visit measures. Enrollment of Sibling Birth Cohort: We will enroll approximately 1,000 sibling births identified among currently enrolled women. Following new pregnancies will allow us to pilot the collection of biospecimens, environmental samples, and standardized neurodevelopmental assessments on sufficient numbers of participants to understand what activities are feasible in specific settings, participants' willingness to complete requested measures, and whether measures are useful and scalable. Participants will be administered the same protocol as approved for the NCS Vanguard Study by the Office of Information and Regulatory Affairs within the Office of Management and Budget, including the collection of environmental samples, biospecimens and physical measurements during pre-pregnancy and pre- and post-natal visits. Those who report that they are trying to conceive will be initially administered the protocols approved for preconception data collection. Others who self-report a pregnancy at a later time will receive pregnancy visit instrumentation and collections.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of three new animal drug applications (NADAs) at the sponsors' request because the products are no longer manufactured or marketed.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.'' This guidance is intended to help small entities and other stakeholders comply with FDA's regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents.

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 PRA).

In an effort to enroll the maximum number of uninsured young Americans into individual health plans in the upcoming open enrollment period, multiple mediums and methods of reaching the uninsured population are necessary. HHS and Young Invincibles are co-sponsoring the ``Healthy Young America'' Video Contest with two primary goals: First, directly reaching the uninsured population through video views and votes; and second, the production of high-quality videos that can be further promoted to the target population.

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: CAPT Michael Montello, Pharm. D., MBA, Cancer Therapy Evaluation Program, Operations and Informatics Branch, 9609 Medical Center Drive, Rockville, MD 20850 or call non-toll-free number (240) 276-6080 or Email your request, including your address to: mike.montello@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: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI), 0925-0625, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The National Cancer Institute (NCI) Central Institutional Review Board (CIRB) provides a centralized approach to human subject protection and provides a cost efficient approach avoiding duplication of effort at each institution. The CIRB provides the services of a fully constituted IRB and provides a comprehensive and efficient mechanism to meet regulatory requirements pertaining to human subject protections including: Initial reviews, continuing reviews, review of amendments, and adverse events. The Initiative consists of three central IRBs: Adult CIRBlate phase emphasis, Adult CIRBearly phase emphasis, and Pediatric CIRB. CIRB membership includes oncology physicians, surgeons, nurses, patient advocates, ethicists, statisticians, pharmacists, attorneys and other health professionals. The benefits of the CIRB Initiative reaches research participants, investigators and research staff, Institutional Review Boards (IRB), and Institutions. Benefits include: Study participants having dedicated review of NCI-sponsored trials for participant protections, access to more trials more quickly and access to trials for rare diseases, accrual to trials begin more rapidly, ease of opening trials, elimination of need to submit study materials to local IRBs, and elimination of the need for a full board review. The benefits to the National Clinical Trials Network and Experimental Therapy-Clinical Trials Network include a cost efficient approach that avoids duplication of efforts at each institution. A variety of information collection tools are needed to support NCI's CIRB activities which include: Worksheets, forms and a survey that is provided to all customers contacting the CIRB helpdesk. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,199.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS), in collaboration with the U.S. Department of Agriculture (USDA), are hereby giving notice that a meeting of the 2015 Dietary Guidelines Advisory Committee (DGAC) will be held. This meeting will be open to the public.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces fees for vessel sanitation inspections for Fiscal Year (FY) 2014. These inspections are conducted by HHS/CDC's Vessel Sanitation Program (VSP). VSP helps the cruise line industry fulfill its responsibility for developing and implementing comprehensive sanitation programs to minimize the risk for acute gastroenteritis. Every vessel that has a foreign itinerary and carries 13 or more passengers is subject to twice-yearly inspections and, when necessary, re-inspection.

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with the Department of Homeland Security (DHS), United States Citizenship and Immigration Services (USCIS).

Under the National Environmental Policy Act of 1969 (NEPA), as implemented by the Council on Environmental Quality (CEQ) regulations, the Food and Drug Administration (FDA) announces its intent to prepare an Environmental Impact Statement (EIS) to evaluate the potential environmental effects of the proposed rule, Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. By this notice, FDA is announcing the beginning of the scoping process to solicit public comments and identify issues to be analyzed in an EIS. Information on the proposed rule may be accessed using the docket number found in brackets in the heading of this document.