Department of Health and Human Services May 2013 – Federal Register Recent Federal Regulation Documents
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Medicare, Medicaid, and Children's Health Insurance Programs; Renewal of the Advisory Panel on Outreach and Education (APOE) and Request for Nominations
This notice announces that the charter of the Advisory Panel on Outreach and Education (APOE) has been renewed. It also requests nominations for individuals to serve on the APOE.
Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE), June 24, 2013
This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning Medicare, Medicaid and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Medicare Program; Notification of Closure of Teaching Hospitals and Opportunity To Apply for Available Slots
This notice announces the closure of two teaching hospitals and the initiation of an application process where hospitals must apply to the Centers for Medicare & Medicaid Services (CMS) for consideration of Infirmary West Hospital's and Montgomery Hospital's full time equivalent (FTE) resident cap slots.
Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
The Food and Drug Administration (FDA or we) is issuing this proposed rule that would require domestic tobacco product manufacturers and importers to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The United States Department of Agriculture (USDA) has been collecting this information and providing FDA with the data FDA needs to calculate the amount of user fees assessed to tobacco product manufacturers and importers. USDA intends to cease collecting this information starting in fiscal year 2015 (October 2014). Consistent with the requirements of the FD&C Act, we are proposing to require the submission of this information to FDA instead of USDA. We are taking this action to ensure that FDA continues to have the information we need to calculate, assess, and collect user fees.
New Approaches to Antibacterial Drug Development; Request for Comments
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is seeking input from the public on the following topics related to antibacterial drug development: Potential new study designs, proposed priorities for CDER guidances, and strategies intended to slow the rate of emerging resistance to antibacterial drugs. The purpose of this notice is to request information and comments from the public on these areas of focus.
Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture'' dated June 2013. The draft guidance document provides manufacturers of licensed Whole Blood and blood components intended for transfusion or for further manufacture, including Source Plasma, with recommendations intended to assist with determining which reporting mechanism is appropriate for submission of changes to an approved biologics license application. The guidance document also provides manufacturers of licensed Whole Blood and blood components recommendations in connection with the applicability and content of comparability protocols and labeling changes. The draft guidance, when finalized, is intended to supersede the document of the same title dated July 2001 (July 2001 guidance).
Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Rheumatoid Arthritis: Developing Drug Products for Treatment.'' This guidance outlines FDA's current thinking on the principles of clinical development relevant to dose-selection and assessment of efficacy and safety to support the approval of drug products for the treatment of patients with rheumatoid arthritis (RA). It also addresses additional considerations for drug products developed as drug-device combination products. This guidance revises the guidance for industry entitled ``Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA),'' published in February 1999.
Agency Information Collections Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) Quality Demonstration Grant Program: Survey Data Collection.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Privacy Act of 1974; System of Records Notice
In accordance with the requirements of the Privacy Act of 1974 (5 USC 552a), the Agency for Healthcare Research and Quality (AHRQ) within the Department of Health and Human Services is establishing a new system of records, ``Online Application Ordering for Products from the Healthcare Cost and Utilization Project (HCUP).'' This online electronic ordering system will streamline and facilitate the dissemination of HCUP databases and software to qualified researchers and result in a more efficient process for both the public and the Agency. The HCUP program and the system of records for the online application ordering process are more thoroughly described in the Supplementary Information section and System of Records Notice (SORN), below.
Meeting of the 2015 Dietary Guidelines Advisory Committee
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.
Request for Public Comment; 30-day Proposed Information Collecton: Indian Self-Determination and Education Assistance Contracts
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for renewal for the collection of information titled, ``Indian Self-Determination and Education Assistance Contracts, 25 C.F.R Part 900,'' OMB Control Number 1076-0136. This proposed information collection project was previously published in the Federal Register (78 FR 15035), as a joint submission with the Bureau of Indian Affairs (BIA), under OMB Control Number 1076- 0136, on March 8, 2013 and allowed 60 days for public comment, as required by 3506(c)(2)(A). No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. This information collection expires May 31, 2013. As of May 2013, the IHS is pursuing its own OMB Control Number for this information collection and will publish notices separately from the BIA in the Federal Register.
Information Required in Prior Notice of Imported Food
The Food and Drug Administration (FDA) is issuing a final rule that adopts, without change, the interim final rule (IFR) entitled ``Information Required in Prior Notice of Imported Food'' that published in the Federal Register (76 FR 25542; May 5, 2011) (2011 IFR). This final rule adopts the IFR's requirement of an additional element of information in a prior notice of imported food, specifically that a person submitting prior notice of imported food, including food for animals, must report the name of any country to which the article has been refused entry.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
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 the information collection contained in the requirements for the submission of labeling for human prescription drugs and biologics in electronic format.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study on Consumer Responses to Nutrition Facts Labels With Various Footnote Formats and Declaration of Amount of Added Sugars
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.
Food and Drug Administration Safety and Innovation Act (FDASIA): Request for Comments on the Development of a Risk-Based Regulatory Framework and Strategy for Health Information Technology
The Food and Drug Administration (FDA), Office of the National Coordinator for Health Information Technology (ONC), and Federal Communication Commission (FCC) seek broad input from stakeholders and experts on the elements we should consider as we develop a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication. To that end, we are requesting comments on the topics identified in Section III.
Submission for OMB Review; 30-Day Comment Request: Women's Health Initiative Observational Study
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), 0020, the National Institutes of Health, 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 February 5, 2013 on pages 8152-8153 and allowed 60-days for public comment. One comment was received and an appropriate response was made. The purpose of this notice is to allow an additional 30 days for public comment. The NHLBI, 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prevention of Salmonella
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.
HHS-Operated Risk Adjustment Data Validation Stakeholder Meeting
This notice announces a public meeting on the Affordable Care Act HHS-operated risk adjustment data validation process. The purpose of this public meeting is to provide opportunity to discuss the HHS risk adjustment data validation process that will be conducted when HHS operates the risk adjustment program on behalf of a state under the Affordable Care Act. The meeting will provide information to stakeholders including, but not limited to, issuers, states, and other interested parties about key HHS policy considerations pertaining to the HHS-operated risk adjustment data validation process and will also provide an opportunity for participants to ask clarifying questions. The stakeholder meeting is being offered as both an in-person meeting and web conference for those unable to attend in person. The comments and information that we obtain through this meeting may aid future policy-making for the HHS-operated risk adjustment data validation process.
Privacy Act of 1974; Report of an Altered CMS System of Records Notice
In accordance with the requirements of the Privacy Act of 1974 (5 USC 552a), CMS proposes the following alterations to existing system of records (SOR) number 09-70-0560 ``Health Insurance Exchanges (HIX) Program,'' published at 78 Federal Register (FR) 8538 (February 6, 2013): 1. Add ``Relevant Individual(s)'' as a new category of individuals; 2. Add personally identifiable information (PII) pertaining to ``Relevant Individual(s)'' as a new category of records; 3. Add new purposes to describe the reason for the above additions; and 4. Revise existing routine uses to authorize the agency to disclose PII of ``Relevant Individual(s)'' to parties outside the agency.
Privacy Act of 1974; Report of a New Routine Use for Selected CMS Systems of Records
In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), CMS is adding a new routine use to twenty-three CMS systems of records to assist in preventing and detecting fraud, waste and abuse. The new routine use will authorize CMS to disclose provider and beneficiary-identifiable records to representatives of health plans for the purpose of preventing and detecting fraud, waste and abuse, pursuant to section 1128C(a)(2) of the Social Security Act (``the Act''). At section 1128C(c) of the Act, a health plan is defined as a plan or program that provides health benefits, whether directly, through insurance, or otherwise, and includes: (1) A policy of health insurance; (2) a contract of a service benefit organization; and (3) a membership agreement with a health maintenance organization or other prepaid health plan. Disclosures made pursuant to the routine use will be coordinated through CMS' Data Sharing and Partnership Group, Center for Program Integrity, CMS. CMS has identified twenty-three systems that contain the data potentially necessary to disclose to health plans for the prevention and detection of fraud, waste and abuse. These systems are listed at the end of this notice.
Announcement of Requirements and Registration for “Be Heads Up About Concussion Safety” Poster Design Contest
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) launches the ``Be Heads Up About Concussion Safety'' poster design contest for children and adolescents ages 5 to 18. HHS/CDC's National Center for Injury Prevention and Control (NCIPC) asks children and adolescents to be creative and send in posters they create by taking concussion safety key messages created by CDC (listed below), or creating their own message(s) on concussion safety, and using them to design a poster. Children and adolescents can draw, paint, or use a computer to design a poster. The poster should be designed to help make aware and educate other children and adolescents about how to spot a concussion or other serious brain injury, what to do if someone may have a concussion or other serious brain injury, and how to help keep safe from these injuries at school, home, or play. Children and adolescents can create their own concussion safety messages or use one or more of the CDC key messages listed below in their poster: Be Heads Up about concussion. Learn more at www.cdc.gov/ Concussion. Be Heads Up about concussion at school, home, and play. Learn more at www.cdc.gov/Concussion. We can all play a role in concussion safety. Learn more at www.cdc.gov/Concussion. Be Heads Up! All concussions are serious. Learn more at www.cdc.gov/Concussion. Get a Heads Up! Learn what to do if you think you have a concussion at www.cdc.gov/Concussion. Getting back in the game with a concussion is a bad call. It could take you out of the game of life, for good. Learn more at www.cdc.gov/Concussion. All concussions are serious. It's better to miss one game than the whole season. Learn more at www.cdc.gov/Concussion. Be Heads Up! If you think you have a concussion: don't hide, report it. Take time to recover. Learn more at www.cdc.gov/ Concussion. This contest is necessary to make children and adolescents aware that there are things they can do to help prevent concussions and other serious brain injuries. We expect the contest will inspire children and adolescents to educate other people and raise awareness of concussion safety in elementary, middle, and high schools in their communities. By showcasing the winning posters in each category of submission ((1) Ages 5-8; (2) Ages 9-12; (3) Ages 13-15; (4) Ages 16-18), we will help children and adolescents reach others with important messaging about concussions and other serious brain injuries. How To Enter: Sign up for a Challenge.gov account and become a follower of the ``Be Heads Up About Concussion Safety'' Poster Design Contest at www.beheadsup.challenge.gov. Review the rules and guidelines of this contest listed below or at www.beheadsup.challenge.gov. Contestants must send in original artwork by email or mail. To send in the poster by email, please send the poster in the form of a photograph, PDF or scanned copy to: DUIPinquiries@cdc.gov. Please use subject line: Heads Up Poster Design Contest. Contestants can also send in posters by mail on a 22 by 28 poster board to: Heads Up Poster Design Contest, 4770 Buford Hwy. NE., Mail Stop F-62, Atlanta, GA 30341. Contestants must include the following information with their poster entry: [cir] Name(s) of the contestant(s) [cir] Age category (Ages 5-8; Ages 9-12; Ages 13-15; Ages 16-18.) Posters entered into the contest will not be returned to contestants. You can use graphic design and other creative methods (including, but not limited to paint, pencil, colored pencils, or crayon) to design your poster. All posters must be in English.
National Institutes of Health
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 Institute of Mental Health (NIMH), 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: Keisha Shropshire, NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or call 301-443-4335 or Email your request, including your address to: kshropsh@mail.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: The National Institute of Mental Health Data Access Request and Use Certification (previously National Database for Autism Research Data Access Request), 0925-0667, Revision, Expiration Date: 01/31/2016; NIMH, NIH. Need and Use of Information Collection: NIMH recently received OMB approval for use of the National Database for Autism Research (NDAR) Data Use Certification (DUC) Form. NIMH is interested in renaming this form the ``NIMH Data Access Request and Use Certification (DUC) Form'' and using it to meet the unique data access needs of all NIMH data repositories. The NIMH DUC form is necessary for ``Recipient'' Principal Investigators and their organization or corporations with approved assurance from the DHHS Office of Human Research Protections to access data or images from NIMH repositories and datasets for research purposes. The primary use of this information is to document, track, monitor, and evaluate the use of the NIMH repositories/datasets, as well as to notify interested recipients of updates, corrections or other changes to the database. There are currently three data repositories/sets positioned to use the NIMH DUC form: NDAR, the NIH Pediatric MRI Data Repository (PedsMRI), and the NIMH Clinical Research Datasets (NCRD). OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 380.
Solicitation of Nominations for Membership on the National Vaccine Advisory Committee
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 soliciting nominations of qualified candidates to be considered for appointment as members to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Management support for the activities of this Committee is the responsibility of the NVPO. Consistent with the National Vaccine Plan, the Committee advises and makes recommendations to the Assistant Secretary for Health in his capacity as the 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.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
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