Department of Health and Human Services April 2, 2013 – Federal Register Recent Federal Regulation Documents

Call for Collaborating Partners for National Women's Health Week
Document Number: 2013-07617
Type: Notice
Date: 2013-04-02
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS), Office on Women's Health (OWH) invites public and private-sector health-related organizations to participate in National Women's Health Week (NWHW) as partners to help create awareness of women's health issues and educate women about improving their health and preventing disease.
Meeting of the Presidential Advisory Council on HIV/AIDS
Document Number: 2013-07614
Type: Notice
Date: 2013-04-02
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting to discuss implementation of the Patient Protection and Affordable Care Act. The meeting will be open to the public.
Medicaid Program; Increased Federal Medical Assistance Percentage Changes Under the Affordable Care Act of 2010
Document Number: 2013-07599
Type: Rule
Date: 2013-04-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule implements the provisions of the Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) relating to the availability of increased Federal Medical Assistance Percentage (FMAP) rates for certain adult populations under states' Medicaid programs. This final rule implements and interprets the increased FMAP rates that will be applicable beginning January 1, 2014 and sets forth conditions for states to claim these increased FMAP rates.
Request For Public Comment: 60-Day Proposed Information Collection: Indian Health Service Medical Staff Credentials And Privileges Files
Document Number: 2013-07596
Type: Notice
Date: 2013-04-02
Agency: Department of Health and Human Services, Indian Health Service
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review.
Center for Devices and Radiological Health: Experiential Learning Program
Document Number: 2013-07593
Type: Notice
Date: 2013-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH or Center) is announcing an invitation for participation in its Experiential Learning Program (ELP). The ELP provides a formal training mechanism for regulatory review staff to visit research, clinical, manufacturing, and health care facilities to observe firsthand how medical devices are designed, developed, and utilized. This training is intended to provide CDRH staff with an opportunity to observe the device development life cycle and provide a better understanding of the medical devices they review, and the challenges faced throughout development, testing, manufacturing, and clinical use. The purpose of this document is to invite medical device and health care facilities to participate in this formal training program for FDA's medical device review staff, or to contact CDRH for more information regarding the program.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2013-07582
Type: Notice
Date: 2013-04-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Extension of Comment Period
Document Number: 2013-07580
Type: Notice
Date: 2013-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the notice entitled ``Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the Improvement of Tracking and Tracing of Food'' that appeared in the Federal Register of March 5, 2013 (78 FR 14309). In the notice, FDA requested comments on the findings and recommendations contained in the Institute of Food Technologists (IFT) report to FDA and the submission of information relevant to improving product tracing. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
International Consortium of Cardiovascular Registries
Document Number: 2013-07579
Type: Notice
Date: 2013-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``International Consortium of Cardiovascular Registries.'' The purpose of this meeting is to discuss the development of an international consortium of cardiovascular registries with a broad array of interested stakeholders. The initial pilot phase of this effort will be developing relationships and analysis strategies for transcatheter cardiac valve registries, with the understanding that these efforts would be expanded to additional cardiovascular devices in the future. Date and Time: The meeting will be held on April 22, 2013, from 8 a.m. to 5 p.m. Location: The public meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. 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. Contact Persons: Benjamin Eloff, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4210, Silver Spring, MD 20993, 301-796-8528, Benjamin.eloff@fda.hhs.gov; or Danica Marinac-Dabic, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4110, Silver Spring, MD 20993, 301-796- 6689, Danica.marinac-dabic@fda.hhs.gov. Registration: Registration is free and will be on a first-come, first-served basis. Persons interested in attending this public meeting must register online by 5 p.m. on April 11, 2013. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 7 a.m. To register for the public meeting, please visit FDA's Medical Devices News & EventsWorkshops & Conferences calendar at http:// www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/de fault.htm. Select this public meeting from the posted events list. Please provide complete contact information for each attendee, including name, title, affiliation, mailing address, email address, and telephone number. Those without Internet access should contact Susan Monahan to register (Susan.Monahan@fda.hhs.gov or 301-796-5661). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. If you need special accommodations due to a disability, please contact Susan Monahan (Susan.Monahan@fda.hhs.gov or 301-796-5661) no later than April 11, 2013. Streaming Webcast of the Public Meeting: This meeting will also be available via Webcast. Persons interested in viewing the Webcast must register online by 5 p.m. on April 11, 2013. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and connection access information after April 16, 2013. If you have never attended a Connect Pro event before, test your connection at https:// collaboration.fda.gov/common/help/en/support/meetingtest.htm. To get a quick overview of the Connect Pro program, visit http:// www.adobe.com/go/connectprooverview. (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.) Comments: FDA is holding this public meeting to obtain information on the topics identified in section II. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public meeting topics. The deadline for submitting comments related to this public meeting is May 22, 2013. No commercial or promotional material will be permitted to be presented or distributed at the meeting. Regardless of attendance at the public meeting, interested persons may submit either electronic comments regarding this document to http:/ /www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Please identify comments with the docket number found in brackets in the heading of this document. 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 http://www.regulations.gov. Transcripts: Transcripts will not be provided.
Change of Address; Biologics License Applications; Technical Amendment
Document Number: 2013-07578
Type: Rule
Date: 2013-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations to update the address for applicants to submit biologics license applications (BLAs) and BLA amendments and supplements regulated by the Center for Drug Evaluation and Research (CDER). This action is being taken to ensure accuracy and clarity in the Agency's regulations.
User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2013-07577
Type: Notice
Date: 2013-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``User Fees and Refunds for Premarket Approval Applications (PMAs) and Device Biologics License Applications (BLAs).'' The purpose of this guidance document is to identify the types of PMAs and BLAs subject to device user fees, including supplements and other submissions, as well as those that do not have an associated user fee. The guidance also identifies industry and FDA actions on these submissions that may result in a refund of the fee. The draft of this document was issued on March 16, 2009.
Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research; Establishment of a Public Docket; Request for Comments
Document Number: 2013-07576
Type: Notice
Date: 2013-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing a public docket for interested parties to submit to FDA comments on the Institute of Medicine's (IOM) recommendation regarding third-party governance of industry-sponsored tobacco product research.
Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule
Document Number: 2013-07568
Type: Notice
Date: 2013-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Wednesday, February 27, 2013 (78 FR 13347). The meeting was shortened to one day, as it was later determined that in order to be more financially prudent all three topics could fit into one day.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-07567
Type: Notice
Date: 2013-04-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-07566
Type: Notice
Date: 2013-04-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-07565
Type: Notice
Date: 2013-04-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse: Notice of Meeting
Document Number: 2013-07564
Type: Notice
Date: 2013-04-02
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-Day Comment Request; Evaluation of the Brain Disorders in the Developing World Program of the John E. Fogarty International Center
Document Number: 2013-07555
Type: Notice
Date: 2013-04-02
Agency: Department of Health and Human Services, 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 John E. Fogarty International Center, 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: Dr. Rachel Sturke, Fogarty International Center, National Institutes of Health, 16 Center Drive, Building 16, Room 202, Bethesda, MD 20892, or call non-toll-free number 301-496-1491, or Email your request, including your address to: sturkerachel@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: Evaluation of the Brain Disorders in the Developing World Program of the John E. Fogarty International Center, 0925-New, Fogarty International Center (FIC), National Institutes of Health (NIH). Need and Use of Information Collection: This study seeks to evaluate the management, effectiveness, and outcomes of the Brain Disorders in the Developing World extramural research program administered by the John E. Fogarty International Center of the NIH. The purpose of the Brain Disorders in the Developing World Program is to develop collaborative research and capacity building projects on brain disorders throughout life relevant to low- and middle-income countries. Awardees are expected to develop innovative projects that contribute to the long-term goal of building sustainable research capacity in nervous system function and impairment throughout life. Between FY 2003 and 2012, a total of 132 awards were made under the Brain Disorders program, and the total investment by Fogarty and its partners at NIH has been approximately $75 million. The findings of this evaluation study will provide valuable information concerning: (1) Whether and how the program has met its goal of supporting research and research capacity-building on brain disorders in low- and middle-income countries; (2) the extent to which the program as implemented functions efficiently and effectively; (3) the extent to which the program is consistent with the strategic priorities of Fogarty and its partners at NIH; (4) opportunities to improve upon the current implementation of the program if NIH chooses to continue supporting it; and (5) models, best practices, and lessons learned that may be applicable to other NIH programs, now and in the future. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 151.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2013-07545
Type: Notice
Date: 2013-04-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-07541
Type: Notice
Date: 2013-04-02
Agency: Department of Health and Human Services, Office of the Secretary
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). 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.
Modifications To Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human Use
Document Number: 2013-07528
Type: Notice
Date: 2013-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that we have concluded that certain statements set forth in the FDA-approved labels of over-the-counter nicotine replacement therapy products, related to concomitant use with other nicotine-containing products and duration of use, can be modified. In light of currently available evidence, these statements are no longer believed to be necessary in their current form to ensure the safe and effective use of over-the- counter nicotine replacement therapy products for their approved intended use as aids to smoking cessation. We encourage the submission of supplemental new drug applications (labeling supplements) to modify these statements as described in this notice.