Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting, 17929-17930 [2010-7929]

Download as PDF Federal Register / Vol. 75, No. 67 / Thursday, April 8, 2010 / Notices nor an environmental impact statement is required. Dated: March 17, 2010. Mitchell A. Cheeseman, Acting Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. 2010–7955 Filed 4–7–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0001] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. sroberts on DSKD5P82C1PROD with NOTICES 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: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on May 7, 2010, from 8 a.m. to approximately 4:30 p.m. Location: Hilton Hotel Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877. Contact Person: Christine Walsh or Denise Royster, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–0314, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting. 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 and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On May 7, 2010, in the morning, the committee will review and discuss available data regarding the unexpected finding of DNA originating VerDate Nov<24>2008 16:26 Apr 07, 2010 Jkt 220001 from porcine circovirus type 1 (PCV 1) in Rotarix, a U.S. licensed vaccine manufactured by GlaxoSmithKline and indicated for the prevention of rotavirus gastroenteritis in infants. The committee will discuss what additional steps should be considered to address this finding. In the afternoon, the committee will discuss and make recommendations on the use of advanced analytical detection methods not currently applied for the characterization of cell substrates, viral seeds, and other biological materials used in the production of viral vaccines for human use. 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 https://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 May 4, 2010. Oral presentations from the public will be scheduled between approximately 10:50 a.m. and 11:20 a.m. and 2:45 p.m. and 3:15 p.m. Those desiring to make 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 April 29, 2010. 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 April 30, 2010. 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 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 17929 require special accommodations due to a disability, please contact Christine Walsh or Denise Royster 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 https://www.fda.gov/Advisory Committees/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: April 2, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2010–8025 Filed 4–7–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children. Dates and Times: May 13, 2010, 8:30 a.m. to 5 p.m. May 14, 2010, 8:30 a.m. to 3:30 p.m. Place: Renaissance Washington, DC Dupont Circle Hotel, 1143 New Hampshire Avenue, NW., Washington, DC 20037. Status: The meeting will be open to the public with attendance limited to space availability. Participants are asked to register for the meeting by going to the registration Web site at https:// events.SignUp4.com/ACHDNC0510. The registration deadline is Tuesday, May 11, 2010. Individuals who need special assistance, such as sign language interpretation or other reasonable accommodations should indicate their needs on the registration Web site. The deadline for special accommodation requests is Friday, May 7, 2010. If there are technical problems gaining access to the Web site, please contact Maureen Ball, Meetings Coordinator, at conferences@altarum.org. Purpose: The Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (Advisory Committee) was established to advise E:\FR\FM\08APN1.SGM 08APN1 sroberts on DSKD5P82C1PROD with NOTICES 17930 Federal Register / Vol. 75, No. 67 / Thursday, April 8, 2010 / Notices and guide the Secretary regarding the most appropriate application of universal newborn screening tests, technologies, policies, guidelines and programs for effectively reducing morbidity and mortality in newborns and children having or at risk for heritable disorders. The Advisory Committee also provides advice and recommendations concerning the grants and projects authorized under the Public Health Service Act, 42 U.S.C. 300b–10, (Heritable Disorders Program) as amended in the Newborn Screening Saves Lives Act of 2008. Agenda: The meeting will include: (1) A presentation of the External Review Workgroup’s final report on the nomination of Hemoglobin H disease to the Advisory Committee’s recommended uniform screening panel; (2) presentations related to the system, information, and technology needs of newborn screening programs; (3) an update on the report being developed by the Sickle Cell Disease Carrier Screening workgroup; and (4) presentations on the continued work and reports of the Advisory Committee’s subcommittees on laboratory standards and procedures, follow-up and treatment, and education and training. Proposed Agenda items are subject to change as priorities dictate. You can locate the Agenda, Committee Roster and Charter, presentations, and meeting materials at the home page of the Advisory Committee’s Web site at https://www.hrsa.gov/ heritabledisorderscommittee/. Web cast: The meeting will be Web cast. Information on how to access the Web cast will be available one week prior to the meeting, May 6, 2010, by clicking on the meeting date link at https://events.SignUp4.com/ ACHDNC0510. Public Comments: Members of the public can present oral comments during the public comment periods of the meeting, which are scheduled for both days of the meeting. Those individuals who want to make a comment are requested to register online by Tuesday, May 11, 2010, at https://events.SignUp4.com/ ACHDNC0510. Requests will contain the name, address, telephone number, and any professional or business affiliation of the person desiring to make an oral presentation. Groups having similar interests are requested to combine their comments and present them through a single representative. The list of public comment participants will be posted on the Web site. Written comments should be e-mailed via e-mail no later than Tuesday, May 11, 2010, for consideration. Comments should be VerDate Nov<24>2008 16:26 Apr 07, 2010 Jkt 220001 submitted to Maureen Ball, Meetings Coordinator, Conference and Meetings Management, Altarum Institute, 1200 18th Street, NW., Suite 700, Washington, DC 20036; telephone: 202– 828–5100; fax: 202–785–3083; or e-mail: conferences@altarum.org. Contact Person: Anyone interested in obtaining other relevant information should write or contact Alaina M. Harris, Maternal and Child Health Bureau, Health Resources and Services Administration, Room 18A–19, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone (301) 443–0721, aharris@hrsa.gov. More information on the Advisory Committee is available at https://mchb.hrsa.gov/ heritabledisorderscommittee. Dated: March 31, 2010. Sahira Rafiullah, Director, Division of Policy and Information Coordination. [FR Doc. 2010–7929 Filed 4–7–10; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Privacy Act of 1974; Report of an Altered System of Records AGENCY: Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA). ACTION: Notice of an Altered System of Records (SOR). SUMMARY: In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to substantially revise ‘‘Public Health Service (PHS) and National Health Service Corps (NHSC) Scholarship/Loan Repayment Participants Records System, HHS/ HRSA/BPHC,’’ HRSA Systems of Records No. 09–15–0037, to reflect organizational and physical location changes, and to update the categories of individuals and records covered by the system. HRSA is also proposing to (a) delete the Nursing Student Education Direct Loan Program, which is not administered by HRSA; (b) add records pertaining to the Nursing Scholarship Program and the Student/Resident Experiences and Rotations in Community Health (SEARCH) Program; and (c) incorporate the Faculty Loan Repayment Program and the Physician Shortage Area Scholarship Program, which previously had their own System PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 of Records Notices (09–15–0058, and 09–15–0042 respectively). These changes will require renaming the system of records and expanding the Authority to maintain the system. HRSA has updated the section on maintenance and storage of records to reflect current technologies, as well as Purpose(s), Safeguards, Retention and Disposal (of records), Notification Procedures, and Records source categories to detail current operations. HRSA is proposing to delete routine uses that are obsolete and to add new routine uses that cover disclosures of information needed for effective program operations. DATES: HRSA filed an altered system report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security and Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) on March 15, 2010. To ensure all parties have adequate time in which to comment, the altered systems, including the routine uses, will become effective 30 days from the publication of the notice or 40 days from the date it was submitted to OMB and Congress, whichever is later, unless HRSA receives comments that require alterations to this notice. ADDRESSES: Please address comments to: Policy Director, Bureau of Clinician Recruitment and Service (BCRS), Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Room 8–15, Rockville, MD 20857, telephone (301) 443–4154, FAX (301) 594–4076. Comments received will be available for inspection at this same address from 9 a.m. to 3 p.m. (Eastern Standard Time Zone), Monday through Friday. FOR FURTHER INFORMATION CONTACT: Associate Administrator, Bureau of Clinician Recruitment and Service (BCRS), Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Room 8–05, Rockville, MD 20857, telephone (301) 594–4200, FAX (301) 594–4076. SUPPLEMENTARY INFORMATION: Major Modification of 09–15–0037 is to reflect the organizational, program, technology, statutory and implementation changes. 1. HRSA proposes to rename the system of records as ‘‘Public Health and National Health Service Corps (PH/ NHSC) Scholarship Training Program, the Physician Shortage Area Scholarship Program (PSASP), National Health Service Corps Scholarship Program (NHSC SP), National Health Service Corps Loan Repayment Program (NHSC LRP), NHSC Student/Resident E:\FR\FM\08APN1.SGM 08APN1

Agencies

[Federal Register Volume 75, Number 67 (Thursday, April 8, 2010)]
[Notices]
[Pages 17929-17930]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7929]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Secretary's Advisory Committee on Heritable Disorders in Newborns 
and Children; Notice of Meeting

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), notice is hereby given of the following 
meeting:
    Name: Secretary's Advisory Committee on Heritable Disorders in 
Newborns and Children.
    Dates and Times: May 13, 2010, 8:30 a.m. to 5 p.m. May 14, 2010, 
8:30 a.m. to 3:30 p.m.
    Place: Renaissance Washington, DC Dupont Circle Hotel, 1143 New 
Hampshire Avenue, NW., Washington, DC 20037.
    Status: The meeting will be open to the public with attendance 
limited to space availability. Participants are asked to register for 
the meeting by going to the registration Web site at https://events.SignUp4.com/ACHDNC0510. The registration deadline is Tuesday, 
May 11, 2010. Individuals who need special assistance, such as sign 
language interpretation or other reasonable accommodations should 
indicate their needs on the registration Web site. The deadline for 
special accommodation requests is Friday, May 7, 2010. If there are 
technical problems gaining access to the Web site, please contact 
Maureen Ball, Meetings Coordinator, at conferences@altarum.org.
    Purpose: The Secretary's Advisory Committee on Heritable Disorders 
in Newborns and Children (Advisory Committee) was established to advise

[[Page 17930]]

and guide the Secretary regarding the most appropriate application of 
universal newborn screening tests, technologies, policies, guidelines 
and programs for effectively reducing morbidity and mortality in 
newborns and children having or at risk for heritable disorders. The 
Advisory Committee also provides advice and recommendations concerning 
the grants and projects authorized under the Public Health Service Act, 
42 U.S.C. 300b-10, (Heritable Disorders Program) as amended in the 
Newborn Screening Saves Lives Act of 2008.
    Agenda: The meeting will include: (1) A presentation of the 
External Review Workgroup's final report on the nomination of 
Hemoglobin H disease to the Advisory Committee's recommended uniform 
screening panel; (2) presentations related to the system, information, 
and technology needs of newborn screening programs; (3) an update on 
the report being developed by the Sickle Cell Disease Carrier Screening 
workgroup; and (4) presentations on the continued work and reports of 
the Advisory Committee's subcommittees on laboratory standards and 
procedures, follow-up and treatment, and education and training.
    Proposed Agenda items are subject to change as priorities dictate. 
You can locate the Agenda, Committee Roster and Charter, presentations, 
and meeting materials at the home page of the Advisory Committee's Web 
site at https://www.hrsa.gov/heritabledisorderscommittee/.
    Web cast: The meeting will be Web cast. Information on how to 
access the Web cast will be available one week prior to the meeting, 
May 6, 2010, by clicking on the meeting date link at https://events.SignUp4.com/ACHDNC0510.
    Public Comments: Members of the public can present oral comments 
during the public comment periods of the meeting, which are scheduled 
for both days of the meeting. Those individuals who want to make a 
comment are requested to register online by Tuesday, May 11, 2010, at 
https://events.SignUp4.com/ACHDNC0510. Requests will contain the name, 
address, telephone number, and any professional or business affiliation 
of the person desiring to make an oral presentation. Groups having 
similar interests are requested to combine their comments and present 
them through a single representative. The list of public comment 
participants will be posted on the Web site. Written comments should be 
e-mailed via e-mail no later than Tuesday, May 11, 2010, for 
consideration. Comments should be submitted to Maureen Ball, Meetings 
Coordinator, Conference and Meetings Management, Altarum Institute, 
1200 18th Street, NW., Suite 700, Washington, DC 20036; telephone: 202-
828-5100; fax: 202-785-3083; or e-mail: conferences@altarum.org.
    Contact Person: Anyone interested in obtaining other relevant 
information should write or contact Alaina M. Harris, Maternal and 
Child Health Bureau, Health Resources and Services Administration, Room 
18A-19, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 
20857, Telephone (301) 443-0721, aharris@hrsa.gov. More information on 
the Advisory Committee is available at https://mchb.hrsa.gov/heritabledisorderscommittee.

    Dated: March 31, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-7929 Filed 4-7-10; 8:45 am]
BILLING CODE 4165-15-P
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