Food and Drug Administration's Transition to the Federal Dockets Management System, 2264-2265 [E8-428]

Download as PDF 2264 ACTION: Federal Register / Vol. 73, No. 9 / Monday, January 14, 2008 / Notices Notice. rmajette on PROD1PC64 with NOTICES SUMMARY: This notice announces the establishment of and invites nominations for members to the Secretary’s Advisory Committee on ReDesignation of Head Start Grantees. The Secretary is required by section 641 of Public Law (Pub. L.) 110–134 to convene an expert panel to provide advice and recommendations on the development of a transparent, reliable and valid system for designation renewal of Head Start grantees. The panel is required to be convened by March 12, 2008. Nominations: We will consider nominations if they are received no later than fifteen (15) days from the date of publication of this notice. Submissions will only be taken electronically, although individuals for whom this procedure introduces a barrier may make alternative arrangements through the contact information below. Nominations in the format described below should be submitted to colleen.rathgeb@acf.hhs.gov. FOR FURTHER INFORMATION CONTACT: Colleen Rathgeb, Office of Head Start, email colleen.rathgeb@acf.hhs.gov or (202) 205–7378. SUPPLEMENTARY INFORMATION: I. Background The Secretary is required by section 641 of Public Law 110–134 to convene an expert panel to provide advice and recommendations on the development of a transparent, reliable and valid system for designation renewal to determine if a Head Start agency is delivering a high-quality and comprehensive Head Start program that meets the educational, health, nutritional, and social needs of the children and families it serves, and meets program and financial management requirements and the program performance standards. The Charter requires that the panel meet up to three times. The panel shall consist of a non-voting chair and seven expert panel members who have expertise in the areas outlined below. Members of the panel serve terms up to two years based on the needs of the panel. The Department will give close attention to equitable geographic distribution and to minority and female representation so long as the effectiveness of the Committee is not diminished. II. Criteria for Nominees All members must have technical expertise to enable them to participate fully in the work of the panel. The panel VerDate Aug<31>2005 15:22 Jan 11, 2008 Jkt 214001 will consist of a non-voting chair and seven members, one member within each of the following demonstrated competency areas, as evidenced by training, expertise and experience: • Early childhood program accreditation, • research on early childhood development, • governance and finance of nonprofit organizations, • delivery of services to populations with special needs and their families, • assessment and evaluation of programs serving young children, • an employee of the Office of Head Start, and • an executive director of a Head Start agency. Any interested person or organization may nominate one or more qualified individuals. Self-nominations will also be accepted. Each nomination must include the following: • Letter of nomination, including which specific expertise above the person is being nominated to fill, • curriculum vitae of the nominee, and • statement from the nominee that the nominee is willing to serve on the panel. III. Copies of the Charter To obtain a copy of the panel’s Charter, submit a written request to the above contact. Dated: January 8, 2008. Daniel C. Schneider, Acting Assistant Secretary, Administration for Children and Families. [FR Doc. 08–88 Filed 1–11–08; 8:45 am] 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 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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 https:// www.Regulations.gov. B. How Can I Access and Use FDMS? FDMS is accessible on the Internet at https://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 E:\FR\FM\14JAN1.SGM 14JAN1 Federal Register / Vol. 73, No. 9 / Monday, January 14, 2008 / Notices 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 https://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 https://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). rmajette on PROD1PC64 with NOTICES III. Additional Information Additional details about FDMS, as well as detailed instructions and assistance for using the system, are available at https://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 VerDate Aug<31>2005 15:22 Jan 11, 2008 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Meeting of the Advisory Council on Blood Stem Cell Transplantation Health Resources and Services Administration, HHS. ACTION: Notice of meeting of the Advisory Council on Blood Stem Cell Transplantation. AGENCY: 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 preregistration 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 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 2265 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 https:// bloodcell.transplant.hrsa.gov/. A registration form will be available on January 7, 2008, on the HRSA’s Program Web site at https:// 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 https://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 E:\FR\FM\14JAN1.SGM 14JAN1

Agencies

[Federal Register Volume 73, Number 9 (Monday, January 14, 2008)]
[Notices]
[Pages 2264-2265]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-428]


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

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 https://www.Regulations.gov.

B. How Can I Access and Use FDMS?

    FDMS is accessible on the Internet at https://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

[[Page 2265]]

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 https://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 https://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 https://
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

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