Department of Health and Human Services November 2012 – Federal Register Recent Federal Regulation Documents
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Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2013 Through September 30, 2014
The Federal Medical Assistance Percentages (FMAP), Enhanced Federal Medical Assistance Percentages (eFMAP), and disaster-recovery FMAP adjustments for Fiscal Year 2014 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2013 through September 30, 2014. This notice announces the calculated FMAP and eFMAP rates that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of federal matching for state medical assistance (Medicaid) and Children's Health Insurance Program (CHIP) expenditures, Temporary Assistance for Needy Families (TANF) Contingency Funds, Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Foster Care Title IV-E Maintenance payments, and Adoption Assistance payments. Table 1 gives figures for each of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. This notice also announces the disaster-recovery FMAP adjustments for qualifying states for FY 2014 that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of federal matching for state medical assistance (Medicaid) and title IV-E Foster Care, Adoption Assistance and Guardianship Assistance programs. Programs under title XIX of the Act exist in each jurisdiction. Programs under titles I, X, and XIV operate only in Guam and the Virgin Islands, while a program under title XVI (Aid to the Aged, Blind, or Disabled) operates only in Puerto Rico. The percentages in this notice apply to state expenditures for most medical assistance and child health assistance, and assistance payments for certain social services. The Act provides separately for federal matching of administrative costs. Sections 1905(b) and 1101(a)(8)(B) of the Social Security Act (the Act) require the Secretary of HHS to publish the FMAP rates each year. The Secretary calculates the percentages, using formulas in sections 1905(b) and 1101(a)(8), and calculations by the Department of Commerce of average income per person in each state and for the Nation as a whole. The percentages must fall within the upper and lower limits given in section 1905(b) of the Act. The percentages for the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands are specified in statute, and thus are not based on the statutory formula that determines the percentages for the 50 States. Section 1905(b) of the Act specifies the formula for calculating FMAPs as follows:
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984.
Advisory Commission on Childhood Vaccines; Notice of Meeting
The Health Resources and Services Administration published a notice in the Federal Register, FR 2012-28377 (77 FR 70169, November 23, 2012), announcing the meeting of the Advisory Commission on Childhood Vaccines, December 6, 2012, in the Parklawn Building (and via audio conference call), Conference Rooms 10-65, 5600 Fishers Lane, Rockville, MD 20857.
Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2013
This notice announces a $532.00 calendar year (CY) 2013 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2013 and on or before December 31, 2013.
Proposed Collection; Comment Request: Healthy Communities Study: How Communities Shape Children's Health (HCS)
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 Heart, Lung, and Blood Institute (NHLBI), 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. Proposed Collection: Title: Healthy Communities Study: How Communities Shape Children's Health (HCS). Type of Information Collection Request: RevisionOMB 0925-0649. Need and Use of Information Collection: The HCS will address the need for a cross- cutting national study of community programs and policies and their relationship to childhood obesity. The HCS is an observational study of communities that aims to (1) determine the associations between community programs/policies and Body Mass Index (BMI), diet, and physical activity in children; and (2) identify the community, family, and child factors that modify or mediate the associations between community programs/policies and BMI, diet, and physical activity in children. A total of 264 communities and over 21,000 elementary and middle school children and their parents will be part of the HCS. A HCS community is defined as a high school catchment area. The study examines quantitative and qualitative information obtained from community-based initiatives; community characteristics (e.g., school environment); measurements of children's physical activity levels and dietary practices; and children's and parents' BMIs. Results from the Healthy Communities Study may influence the future development and funding of policies and programs to reduce childhood obesity. Furthermore, HCS results will be published in scientific journals and will be used for the development of future research initiatives targeting childhood obesity. Frequency of Response: One time. Affected Public: Families or households; businesses, other for-profit, and non- profit. Type of Respondents: Parents, children, community key informants (who have knowledge about community programs/policies related to healthy nutrition, physical activity, and healthy weight of children), food service personnel, physical education instructors, school liaisons, and physicians or medical secretaries. The annual reporting burden is as follows: Estimated number of respondents: 207,029; Estimated Number of Responses per Respondent: 1; and Estimated Total Burden Hours Requested: 35,588. The annualized cost to respondents is estimated at $458,189. There are no capital, operating, or maintenance costs to report.
Irradiation in the Production, Processing and Handling of Food
The Food and Drug Administration (FDA) is amending the food additive regulations to increase the maximum dose of ionizing radiation permitted in the treatment of poultry products, to include specific language intended to clarify the poultry products covered by the regulations, and to remove the limitation that any packaging used during irradiation of poultry shall not exclude oxygen. This action is in response to a petition filed by the U.S. Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS).
Irradiation in the Production, Processing and Handling of Food
The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of a 4.5 kilogray (kGy) maximum absorbed dose of ionizing radiation to treat unrefrigerated (as well as refrigerated) uncooked meat, meat byproducts, and certain meat food products to reduce levels of foodborne pathogens and extend shelf life. This action is in response to a petition filed by the U.S. Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS).
Announcement of Intent To Establish the 2015 Dietary Guidelines Advisory Committee and Solicitation of Nominations for Appointment to the Committee Membership; Amendment
A notice was published in the Federal Register of Friday, October 26, 2012, Vol. 77, No. 208, to announce the intent to establish the 2015 Dietary Guidelines Advisory Committee and solicit nominations of individuals who are interested in being appointed to the Committee membership. This notice is being amended to extend the solicitation period to allow additional time for nominations to be received. The new due date for all nominations to be received is no later than close of business on December 11, 2012.
Agency Information Collection Activities; Proposed Collection; Comment Request; Revision of the Requirements for Constituent Materials
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 regarding the requirement for the use of constituent materials in licensed biological products.
Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products,'' dated November 2012. The draft guidance document provides sponsors and individuals that design and implement preclinical studies with recommendations on the substance and scope of preclinical information needed to support clinical trials for investigational products regulated by the Center for Biologics Research and Evaluation (CBER), Office of Cellular, Tissue, and Gene Therapies (OCTGT). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic vaccination, and xenotransplantation. The guidance is intended to clarify current expectations regarding the preclinical information that supports an investigational new drug application (IND) and a biologics license application (BLA) for these product areas.
FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing; Request for Comments
The Food and Drug Administration (FDA) is announcing a 1-day public hearing to obtain input on certain questions related to the implementation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). This public hearing is being held to obtain comments from the public on FDA consideration of applicable approval mechanisms and additional indications for nicotine replacement therapies (NRTs), and to request input on a report to Congress examining the regulation and development of innovative products and treatments for tobacco dependence.
Uniform Compliance Date for Food Labeling Regulations
The Food and Drug Administration (FDA or we) is establishing January 1, 2016, as the uniform compliance date for food labeling regulations that are issued between January 1, 2013, and December 31, 2014. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On December 15, 2010, we established January 1, 2014, as the uniform compliance date for food labeling regulations issued between January 1, 2011, and December 31, 2012.
Guidance for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products; Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance entitled ``Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products,'' that was announced in the Federal Register on June 8, 2010.
Framework for Pharmacy Compounding: State and Federal Roles
The Food and Drug Administration (FDA) is announcing the following public meeting entitled ``Framework for Pharmacy Compounding: State and Federal Roles.'' At this public meeting, FDA and State representatives will share their perspectives. Date and Time: The public meeting will be held on December 19, 2012, from 3 p.m. to 5 p.m. Onsite registration will be on a first- come, first-served basis beginning at 2 p.m. Location: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http:/ /www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ucm241740.htm. If you need special accommodations due to a disability, please contact Steve Morin, FDA Office of Special Health Issues, 301-796-0161, email: Steve.Morin@fda.hhs.gov no later than December 14, 2012. Contact Person: Patricia Kuntze, Food and Drug Administration, 10903 New H Ave., Bldg. 32, Rm. 5322, Silver Spring, MD 20993; patricia.kuntze@fda.hhs.gov. Streaming Webcast of the Meeting: This public meeting will also be Webcast. Persons interested in viewing the Webcast should use the access connection at https://collaboration.fda.gov/ pharmacycompounding/. The Webcast will begin on December 19, 2012, at 3 p.m. ET. If you have never attended a Connect Pro meeting before, test your connection at: https://collaboration.fda.gov/common/help/en/support/ meetingtest.htm. Get a quick overview at: https://www.adobe.com/go/ connectprooverview. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries. If for some reason the test page does not work, that is not a definite indicating factor that the actual Webcast will not work. The test link sometimes appears to be broken on some individuals' computers. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) This Webcast will be closed captioned. Comments: In order to obtain public comment, FDA is also soliciting either electronic or written comments on the issues discussed in section II of this document. The deadline for submitting comments is January 18, 2013. Regardless of attendance at the meeting, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 or electronic comments to https://www.regulations.gov. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. In addition, when submitting comments on issues as outlined in section II of this document, please identify the issue you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Notice of Public Meeting
The session will allow members of the public the opportunity to provide individual feedback on the recommendations included in the Report of the WHO's Consultative Expert Working Group on R&D Financing and Coordination (CEWG).
Meeting of the President's Council on Fitness, Sports, and Nutrition
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that the President's Council on Fitness, Sports, and Nutrition (PCFSN) will hold a meeting (Webinar format only). The meeting will be open to the public. Registration is required.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Sodium Nitrite Injection and Sodium Thiosulfate Injection Drug Products Labeled for the Treatment of Cyanide Poisoning; Enforcement Action Dates
The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved injectable drug products containing sodium nitrite labeled for the treatment of cyanide poisoning and unapproved injectable drug products containing sodium thiosulfate labeled for the treatment of cyanide poisoning, and persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. Cyanide antidotes carry serious risks and some unapproved drug products may lack Boxed Warnings and other warnings required in the labeling of approved cyanide antidotes. These unapproved drug products compete with approved products, and thus pose a direct challenge to the drug approval system. Injectable drug products containing sodium nitrite or sodium thiosulfate that are labeled for the treatment of cyanide poisoning are new drugs that require approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in order to be legally marketed.
Medicare and Medicaid Programs; Approval of the Accreditation Association for Ambulatory Health Care (AAAHC) Application for Continuing CMS Approval of Its Ambulatory Surgical Center Accreditation Program
This final notice announces our decision to approve the Accreditation Association for Ambulatory Health Care (AAAHC) for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare and/or Medicaid programs.
Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE), December 18, 2012
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.
Government-Owned Inventions; Availability for Licensing
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. 207 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.
Request for Information Regarding Health Care Quality for Exchanges
This notice is a request for information to seek public comments regarding health plan quality management in Affordable Insurance Exchanges.
Medicare and Medicaid Programs; Approval of the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for Continuing CMS Approval of Its Ambulatory Surgical Center Accreditation Program
This notice announces our decision to approve the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs.
Medicare Program; Semi-Annual Meeting of the Advisory Panel on Hospital Outpatient Payment (HOP Panel)-March 11 and 12, 2013
This notice announces the first semi-annual meeting of the Advisory Panel on Hospital Outpatient Payment (HOP, the Panel), (the Ambulatory Payment Classification (APC) Panel) for 2013. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on the clinical integrity of the APC groups and their associated weights, and hospital outpatient therapeutic supervision issues.
Report of the Evidence-Based Methodology Workshop on Polycystic Ovary Syndrome-Request for Comments
The National Institutes of Health (NIH) will place in the docket for public review and comment a report resulting from the NIH Evidence-Based Methodology Workshop on Polycystic Ovary Syndrome, to be held December 3-5, 2012. The purpose of the report is to summarize the workshop and identify future research priorities. The report will be available online beginning December 7, 2012, at https://prevention.nih.gov/ workshops/2012/pcos/default.aspx.
Office of the National Coordinator for Health Information Technology; Health Information Technology; HIT Policy Committee: Request for Comment Regarding the Stage 3 Definition of Meaningful Use of Electronic Health Records (EHRs)
This notice announces the HIT Policy Committee's request for comments on its draft recommendations for meaningful use Stage 3.
Proposed Collection; Comment Request; Methodological Studies for the Population Assessment of Tobacco and Health (PATH) Study
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 on Drug Abuse (NIDA), 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. Proposed Collection: Title: Methodological Studies for Population Assessment of Tobacco and Health (PATH) Study. Type of Information Collection Request: New. Need and Use of Information Collection: The PATH study will establish a population-based framework for monitoring and evaluating the behavioral and health impacts of regulatory provisions implemented as part of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) by the Food and Drug Administration (FDA). NIDA is requesting generic approval from OMB for methodological studies to improve the PATH study instrumentation and data collection procedures. These methodological studies will support ongoing assessment and refinement of the PATH study's design, and highlight ways to improve study implementation and techniques for retention and followup. Data collection methods to be used in these methodological studies include: in-person and telephone surveys; web and smartphone/ mobile phone surveys; and focus group and individual in-depth qualitative interviews. Biospecimens may also be collected from adults. Frequency of Response: Annual [As needed on an on-going and concurrent basis]. Affected Public: Individuals. Type of Respondents: Youth (ages 12-17) and Adults (ages 18+). Annual Reporting Burden: See Table 1. The annualized cost to respondents is estimated at: $227,562. There are no capital, operating or maintenance costs.
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, 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 renewal of the approved information collection assigned OMB control number 0990-0302, scheduled to expire on November 31, 2012. 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.
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