Science Board to the Food and Drug Administration; Notice of Meeting, 6332-6333 [2013-01944]

Download as PDF mstockstill on DSK4VPTVN1PROD with 6332 Federal Register / Vol. 78, No. 20 / Wednesday, January 30, 2013 / Notices (HCPPs) contracting with the Secretary under Section 1833 of the Social Security Act are required to submit a budget and enrollment forecast, semiannual interim report, and final cost report in accordance with 42 CFR 417.808 and 42 CFR 417.810. CMS is requesting approval for the reinstatement with change of Form CMS–276 (OCN: 0938–0165). This Cost Report outlines the provisions for implementing Section 1876(h) and Section 1833(a)(1)(A) of the Social Security Act. The purposes of the revisions were to implement some changes in response to the Affordable Care Act, clarify certain instructions, and update outdated issues within the Cost Report. Form Number: CMS–276 (OMB# 0938–0165); Frequency: Annually; Affected Public: Private Sector—Business or other for-profits and not-for-profit institutions; Number of Respondents: 29; Total Annual Responses: 106; Total Annual Hours: 1,384. (For policy questions regarding this collection contact Temeshia Johnson at 410–786–8692. For all other issues call 410–786–1326.) 2. Type of Information Collection Request: Reinstatement with change of a previously approved collection; Title of Information Collection: Medicare Provider Cost Report Reimbursement Questionnaire; Use: The purpose of Form CMS–339 is to assist the provider in preparing an acceptable cost report and to minimize subsequent contact between the provider and its Medicare Administrative Contractor (MAC). Form CMS–339 provides the basic data necessary to support the information in the cost report. Exhibit 1of Form CMS– 339 contains a series of reimbursementoriented questions which serve to update information on the operations of the provider. It is arranged topically regarding financial activities such as independent audits, provider organization and operation, etc. The MAC is responsible for the settlement of the Medicare cost report and must determine the reasonableness and the accuracy of the reimbursement claimed. This process includes performing both a desk review of the cost report and an analysis leading to a decision to settle the cost report with or without further audit. Form CMS–339 provides essential information to enable the MAC to make the audit or no audit decision, scope of the audit if one is necessary, and to update the provider documentation (i.e., documentation to support the financial profile of the provider). If the information is not collected, the MAC will have to go onsite to each provider to get this information. Consequently, it VerDate Mar<15>2010 20:43 Jan 29, 2013 Jkt 229001 is far less burdensome and extremely cost effective to capture this information through the Form CMS–339. Exhibit 2 of Form CMS–339 is a listing of bad debts pertaining to uncollectible Medicare deductible and coinsurance amounts. Preparation of the listing is a convenient way for providers to supply the MAC with information needed to determine the allow ability of the bad debts for reimbursement. Some items required to determine allow ability that are included on this exhibit are patient’s name, dates of service, date first bill sent to beneficiary, and date the collection effort ceased. Supplying the MAC with this information may be all that is required for the MAC to determine whether or not the bad debt is allowable. This too may eliminate a visit to the provider to gather this needed data. Form Number: CMS–339 (OCN: 0938–0301); Frequency: Yearly; Affected Public: Private Sector— Business or other for-profits and not-forprofit institutions; Number of Respondents: 17,939; Total Annual Responses: 17,939; Total Annual Hours: 53,817. (For policy questions regarding this collection contact Christine Dobrzycki at 410–786–3389. For all other issues call 410–786–1326.) To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web site address at http://www.cms.hhs.gov/ PaperworkReductionActof1995, or Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by April 1, 2013: 1. Electronically. You may submit your comments electronically to http:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number _________, Room C4– 26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 Dated: January 24, 2013. Martique Jones, Deputy Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2013–01849 Filed 1–29–13; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No: FDA–2013–N–0001] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex scientific and technical issues important to the FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science; and input into the Agency’s research agenda; and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency-sponsored intramural and extramural scientific research programs. Date and Time: The meeting will be held on Wednesday, February 27, 2013, from approximately 8:30 a.m. to 5:15 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993. For those unable to attend in person, the meeting will also be webcast. The link for the webcast is available at https:// collaboration.fda.gov/scienceboard/. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White E:\FR\FM\30JAN1.SGM 30JAN1 mstockstill on DSK4VPTVN1PROD with Federal Register / Vol. 78, No. 20 / Wednesday, January 30, 2013 / Notices Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Martha Monser, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4286, Silver Spring, MD 20993, 301–796– 4627, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at http://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On February 27, 2013, the Science Board will be provided with updates and/or draft reports from the Center for Devices and Radiological Health Research Review subcommittee and the Global Health subcommittee. A progress update will be presented regarding the recently established Center for Biologics Evaluation and Review Post-Marketing Safety Review subcommittee. An update on the plan to establish a new subcommittee to evaluate the Agency’s continuing work to address the challenges identified in Science Board’s 2007 ‘‘Science and Mission at Risk’’ Report will be presented. Plans will also be presented and a proposed charge reviewed for a second subcommittee to assess similar issues with respect to information technology including evaluation of scientific data utilization, data liberation and innovation. Overviews of genomics activities at the Centers for Food Safety and Applied Nutrition and Veterinary Medicine will be presented, along with plans for an Agency-wide working group to address cross-cutting genomics activities. Finally, recipients of the FY2012 Scientific Achievement awards (selected by the Science Board) will provide overviews of the activities for which the awards were given. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is VerDate Mar<15>2010 20:43 Jan 29, 2013 Jkt 229001 6333 available at http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before Wednesday, February 20, 2013. Oral presentations from the public will be scheduled between approximately 4:30 p.m. and 5 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before Tuesday, February 12, 2013. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by Wednesday, February 13, 2013. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Martha Monser at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: January 24, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. Dated: January 24, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–01944 Filed 1–29–13; 8:45 am] [FR Doc. 2013–01880 Filed 1–29–13; 8:45 am] BILLING CODE 4160–01–P BILLING CODE 4140–01–P PO 00000 Frm 00045 Fmt 4703 Sfmt 9990 National Institutes of Health National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; VSL Fellowships. Date: February 21, 2013. Time: 12:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6120 Executive Blvd. Rockville, MD 20852 (Telephone Conference Call). Contact Person: Sheo Singh, Ph.D., Scientific Review Officer, National Institute on Deafness and Other Communication Disorders National Institutes of Health, Rockville, MD 20850, 301–496–8693, singhs@nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; Training in Hearing Research Review Meeting. Date: February 26, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015. Contact Person: Andrea B. Kelly, Ph.D., Scientific Review Officer, National Institute on Deafness and Other Communication Disorders National Institutes of Health, Rockville, MD 20850, 301–496–8683, kellya2@nidcd.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of Health, HHS) E:\FR\FM\30JAN1.SGM 30JAN1

Agencies

[Federal Register Volume 78, Number 20 (Wednesday, January 30, 2013)]
[Notices]
[Pages 6332-6333]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01944]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No: FDA-2013-N-0001]


Science Board to the Food and Drug Administration; Notice of 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Science Board to the Food and Drug 
Administration (Science Board).
    General Function of the Committee: The Science Board provides 
advice primarily to the Commissioner of Food and Drugs and other 
appropriate officials on specific complex scientific and technical 
issues important to the FDA and its mission, including emerging issues 
within the scientific community. Additionally, the Science Board 
provides advice to the Agency on keeping pace with technical and 
scientific developments including in regulatory science; and input into 
the Agency's research agenda; and on upgrading its scientific and 
research facilities and training opportunities. It will also provide, 
where requested, expert review of Agency-sponsored intramural and 
extramural scientific research programs.
    Date and Time: The meeting will be held on Wednesday, February 27, 
2013, from approximately 8:30 a.m. to 5:15 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 
20993. For those unable to attend in person, the meeting will also be 
webcast. The link for the webcast is available at https://collaboration.fda.gov/scienceboard/. Information regarding special 
accommodations due to a disability, visitor parking, and transportation 
may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; 
under the heading ``Resources for You,'' click on ``Public Meetings at 
the FDA White

[[Page 6333]]

Oak Campus.'' Please note that visitors to the White Oak Campus must 
enter through Building 1.
    Contact Person: Martha Monser, Office of the Chief Scientist, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4286, 
Silver Spring, MD 20993, 301-796-4627, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: On February 27, 2013, the Science Board will be provided 
with updates and/or draft reports from the Center for Devices and 
Radiological Health Research Review subcommittee and the Global Health 
subcommittee. A progress update will be presented regarding the 
recently established Center for Biologics Evaluation and Review Post-
Marketing Safety Review subcommittee. An update on the plan to 
establish a new subcommittee to evaluate the Agency's continuing work 
to address the challenges identified in Science Board's 2007 ``Science 
and Mission at Risk'' Report will be presented. Plans will also be 
presented and a proposed charge reviewed for a second subcommittee to 
assess similar issues with respect to information technology including 
evaluation of scientific data utilization, data liberation and 
innovation. Overviews of genomics activities at the Centers for Food 
Safety and Applied Nutrition and Veterinary Medicine will be presented, 
along with plans for an Agency-wide working group to address cross-
cutting genomics activities. Finally, recipients of the FY2012 
Scientific Achievement awards (selected by the Science Board) will 
provide overviews of the activities for which the awards were given.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
Wednesday, February 20, 2013. Oral presentations from the public will 
be scheduled between approximately 4:30 p.m. and 5 p.m. Those 
individuals interested in making formal oral presentations should 
notify the contact person and submit a brief statement of the general 
nature of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before 
Tuesday, February 12, 2013. Time allotted for each presentation may be 
limited. If the number of registrants requesting to speak is greater 
than can be reasonably accommodated during the scheduled open public 
hearing session, FDA may conduct a lottery to determine the speakers 
for the scheduled open public hearing session. The contact person will 
notify interested persons regarding their request to speak by 
Wednesday, February 13, 2013.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Martha Monser at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 24, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-01944 Filed 1-29-13; 8:45 am]
BILLING CODE 4160-01-P