Notices. Notice
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/register/2008/01/14/08-83A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration's Transition to the Federal Dockets Management System AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is providing notice that effective January 15, 2008, the public will no longer be able to submit electronic comments to its Dockets through FDA's Web site. Electronic comments to FDA's Dockets may continue to be submitted through the Federal eRulemaking Portal. In recent months, FDA has alerted the public through our published **Federal Register** documents that after the transition date, electronic submissions will only be accepted by FDA through Federal Dockets Management System (FDMS). Please note that the process for submitting written comments to FDA's Dockets will remain the same. FOR FURTHER INFORMATION CONTACT: The Division of Dockets Management Public Room (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 1061, Rockville, MD 20852, 301-827-6860, or FAX: 301-827-6870. SUPPLEMENTARY INFORMATION: I. Background: FDMS is a major component of the President's e-Rulemaking Initiative, which provides easy access to the public dockets maintained by Federal agencies, while streamlining and increasing the efficiency of the internal, regulatory procedures for agencies. FDMS is designed so that the public has a single point of access to the public dockets across the Federal government and agencies have a standard, online procedure to manage and process dockets, documents, and public comments/submissions. The Initiative reduces costs by eliminating duplicative information systems and technical infrastructures. A. What is FDMS? FDMS is a full-featured electronic docket management system that gives Federal personnel and docket managers the ability to better manage their rulemakings, adjudications, and other docketed program activities. FDMS also provides the public with a one-stop site to search, view and download documents, as well as post comments/submissions to federal agencies. FDMS makes it easier for all segments of the public with access to a computer and the Internet—whether at home, at work, or at a local library— to submit comments to agency dockets. FDMS is accessible on the Internet at *http://www.Regulations.gov* . B. How Can I Access and Use FDMS? FDMS is accessible on the Internet at *http://www.Regulations.gov* . The public may use FDMS to access available public docket materials online, as well as submit electronic comments to a particular docket available in FDMS. C. How Can I Search FDMS? FDMS provides two basic methods of searching to retrieve dockets and docket materials that are available in the system:
(1)Quick Search to search using a full-text search engine and Browsing options or
(2)Advance Search which displays various indexed fields such as the docket name, docket identification number, agency, date of issuance, document title, document identification
(ID)number, type of documents, etc. Each data field in the advance search may be searched independently or in combination with other fields, as desired. Each search yields a simultaneous display of all available information found in FDMS that is relevant to the requested subject or topic. D. How Can I Post Comments/Submissions to FDMS? The public may post comments/submissions online to FDMS on the Internet at *http://www.Regulations.gov* when a particular docket is open for public comment/submissions. For each Docket, FDA will issue a **Federal Register** notice or other document that provides information and instructions on posting comments/submissions to FDMS. II. Migration from the Division of Dockets Management
(DDM)to FDMS A. Phased Migration Using a phased approach, all dockets currently managed by FDA's DDM will be moved to FDMS. After the migration, the public will be able to access FDA Dockets at *Regulations.gov* . On this Web site, the public will be able to read background dockets, public comments the agency has received, etc. Due to the tremendous amount of data to be transferred from FDA's DDM to FDMS, the migration will occur over the next few months. Until a Docket is migrated, the public will continue to be able to access it through FDA's Web Site at *http://www.fda.gov/ohrms/dockets* . B. Docket ID Numbers Any Docket created after January 15, 2008, will receive a docket ID established by FDMS. Any Docket created on or before January 15, 2008, and migrated to FDMS will receive a docket ID established by FDMS, but it will also include a reference to its original docket (identification) number that had been assigned by FDA (legacy numbers). III. Additional Information Additional details about FDMS, as well as detailed instructions and assistance for using the system, are available at *http://www.Regulations.gov* . Dated: January 8, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-428 Filed 1-11-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Meeting of the Advisory Council on Blood Stem Cell Transplantation AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice of meeting of the Advisory Council on Blood Stem Cell Transplantation. SUMMARY: Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the first meeting of the Advisory Council on Blood Stem Cell Transplantation (ACBSCT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on January 28, 2008, and from 9 a.m. to 5 p.m. on January 29, 2008, at the Hilton Washington DC/Rockville Executive Meeting Center, 1750 Rockville Pike, MD 20852. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below). SUPPLEMENTARY INFORMATION: Pursuant to Public Law 109-129, 42 U.S.C. 274k (section 379 of the Public Health Service Act, as amended) the ACBSCT was established to advise the Secretary of HHS and the Administrator, HRSA, on matters related to the activities of the C.W. Bill Young Cell Transplantation Program (Program) and the National Cord Blood Inventory
(NCBI)Program. ACBSCT is composed of up to 25 members, including the Chair, serving as Special Government Employees. The current membership includes representatives of marrow donor centers and marrow transplant centers; representatives of cord blood banks and participating birthing hospitals; recipients of a bone marrow transplant; recipients of a cord blood transplant; persons who require such transplants; family members of such a recipient or family members of a patient who has requested the assistance of the Program in searching for an unrelated donor of bone marrow or cord blood; persons with expertise in bone marrow and cord blood transplantation; persons with expertise in typing, matching, and transplant outcome data analysis; persons with expertise in the social sciences; basic scientists with expertise in the biology of adult stem cells; ethicists; hematology and transfusion medicine researchers with expertise in adult blood stem cells; persons with expertise in cord blood processing; and members of the general public. ACBSCT will hear presentations on and discuss cord blood bank accreditation for the NCBI Program; the Food and Drug Administration's
(FDA)Draft Guidance for Cord Blood Bank Licensure; Program confidentiality policies; Program registry size and composition; the Related Cord Blood Donor Demonstration Project; and the scientific factors that define a high quality cord blood unit. The draft meeting agenda will be available on January 15, 2008, on the HRSA's Program Web site at *http://bloodcell.transplant.hrsa.gov/.* A registration form will be available on January 7, 2008, on the HRSA's Program Web site at *http://bloodcell.transplant.hrsa.gov/.* The completed registration form should be submitted by facsimile to Professional and Scientific Associates (PSA), the logistical support contractor for the meeting, at fax number
(703)234-1701. Individuals without access to the Internet who wish to register may call Sowjanya Kotakonda with PSA at
(703)234-1737. Registration can also be completed electronically at *https://www.team-psa.com/dot/2008/acbsct/* . Individuals who plan to attend the meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the ACBSCT Executive Secretary, Remy Aronoff, in advance of the meeting. Mr. Aronoff may be reached by telephone at 301-443-3264, e-mail: *Remy.Aronoff@hrsa.hhs.gov* or in writing at the address provided below. Management and support services for ACBSCT functions are provided by the Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Parklawn Building, Room 12C-06, Rockville, Maryland 20857; telephone number 301-443-7577. After the presentations and Council discussions, members of the public will have an opportunity to provide comments. Because of the Council's full agenda and the timeframe in which to cover the agenda topics, public comment will be limited. All public comments will be included in the record of the ACBSCT meeting. Meeting summary notes will be made available on the HRSA's Program Web site at *http://bloodcell.transplant.hrsa.gov/.* Dated: January 7, 2008. Elizabeth M. Duke, Administrator. [FR Doc. E8-366 Filed 1-11-08; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Heart, Lung, and Blood Advisory Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting 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 Heart, Lung, and Blood Advisory Council. *Date:* February 13, 2008. *Open:* 8 a.m. to 12 p.m. *Agenda:* To discuss program policies and issues. *Place:* National Institutes of Health, Building 31, 31 Center Drive, Conference Room 10, Bethesda, MD 20892. *Closed:* 1 p.m. to 4 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, Building 31, 31 Center Drive, Conference Room 10, Bethesda, MD 20892. *Contact Person:* Stephen Mockrin, PhD, Director, Division of Extramural Research Activities, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7100, Bethesda, MD 20892,
(301)435-0260, *mockrins@nhlbi.nih.gov.* Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit. Information is also available on the Institute's/Center's home page: *http://www.nhlbi.nih.gov/meetings/index.htm,* where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: January 7, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08-83 Filed 1-11-08; 8:45 am]
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- Pub. L. 92-463
- Pub. L. 109-129
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