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6284 Federal Register / Vol. 71, No. 25 / Tuesday, February 7, 2006 / Notices
health. FDA said that the proposed MD 20852. Submit electronic comments • Potential alternative approaches to
changes would be an important step to http://www.fda.gov/dockets/ donor screening and testing.
toward global harmonization of safety ecomments. Transcripts: Transcripts of the public
reporting requirements and additional Contact Person: Rhonda Dawson, workshop may be requested in writing
efforts are underway within the Center for Biologics Evaluation and from the Freedom of Information Office
Department of Health and Human Research (HFM–302), Food and Drug (HFI–35), Food and Drug
Services to harmonize the reporting Administration, 1401 Rockville Pike, Administration, 5600 Fishers Lane, rm.
requirements of U.S. Federal agencies Rockville, MD 20852–1448, 301–827– 12A–16, Rockville, MD 20857,
(e.g., FDA and the National Institutes of 6129, FAX: 301–827–2843, e-mail: approximately 15 working days after the
Health are continuing to work together Rhonda.Dawson@fda.hhs.gov. public workshop at a cost of 10 cents
to address the best ways to streamline Registration: Mail, fax, or e-mail your per page. A transcript of the public
information sharing and to harmonize, registration information (including workshop will be available on the
to the extent possible, the safety name, title, firm name, address, and Internet at http://www.fda.gov/cber/
reporting requirements of the two telephone and fax numbers) to Rhonda minutes/workshop-min.htm.
agencies). Dawson (see Contact Person) by
February 17, 2006. There is no Dated: January 31, 2006.
Dated: January 30, 2006. registration fee for the public workshop. Jeffrey Shuren,
Jeffrey Shuren, Early registration is recommended Assistant Commissioner for Policy.
Assistant Commissioner for Policy. because seating is limited. Registration [FR Doc. E6–1588 Filed 2–6–06; 8:45 am]
[FR Doc. E6–1587 Filed 2–6–06; 8:45 am] on the day of the public workshop will BILLING CODE 4160–01–S
BILLING CODE 4160–01–S be provided on a space-available basis
beginning at 7:15 a.m.
If you need special accommodations DEPARTMENT OF HEALTH AND
DEPARTMENT OF HEALTH AND due to a disability, please contact HUMAN SERVICES
HUMAN SERVICES Rhonda Dawson (see Contact Person) at
least 7 days in advance. Food and Drug Administration
Food and Drug Administration Comments: Regardless of attendance
at the public workshop, interested Independent Evaluation of the Food
[Docket No. 2006N–0045] and Drug Administration’s First Cycle
persons may submit to the Division of
Dockets Management (see Addresses) Review Performance—Retrospective
Behavior-Based Blood Donor Deferrals
written or electronic comments Analysis Final Report; Availability
in the Era of Nucleic Acid Testing;
Public Workshop; Request for regarding the public workshop. Submit AGENCY: Food and Drug Administration,
Comments electronic comments to http:// HHS.
www.fda.gov/dockets/ecomments.
AGENCY: Food and Drug Administration, Submit a single copy of electronic ACTION: Notice of availability.
HHS. comments or two paper copies of any SUMMARY: The Food and Drug
ACTION: Notice of public workshop; mailed comments, except that Administration (FDA) is announcing the
request for comments. individuals may submit one paper copy. availability of a report entitled
Comments are to be identified with the ‘‘Independent Evaluation of FDA’s First
The Food and Drug Administration docket number found in brackets in the
(FDA) is announcing a public workshop Cycle Review Performance—
heading of this document. Received Retrospective Analysis Final Report.’’
entitled ‘‘Behavior-Based Blood Donor comments may be seen in the Division
Deferrals in the Era of Nucleic Acid This report describes an independent
of Dockets Management between 9 a.m. evaluation of the issues associated with
Testing (NAT).’’ The purpose of the and 4 p.m., Monday through Friday.
public workshop is to address FDA’s conduct of first cycle reviews of
SUPPLEMENTARY INFORMATION: The new molecular entities for new drug
regulatory and scientific challenges and purpose of the public workshop is to
opportunities in the development of applications (NMEs for NDAs), and
address regulatory and scientific biological license applications (BLAs).
policy concerning protection of the challenges and opportunities in the
blood supply from transfusion- Applications covered by the report are
development of policy concerning those submitted to FDA in fiscal years
transmissible diseases by deferring protection of the blood supply from
blood donors based on high-risk 2002 to 2004. This independent study
transfusion-transmissible diseases by was conducted in relation to the
behavior, and to request comments on deferring blood donors based on high-
this topic. Prescription Drug User Fee
risk behavior. The public workshop will Amendments of 2002 (PDUFA III). This
Date and Time: The public workshop feature presentations by national and
will be held on March 8, 2006, from 8 assessment includes a detailed
international experts from government evaluation of the events that occurred
a.m. to 5:30 p.m. The deadline for and academic institutions and industry.
registration via mail, fax, or e-mail is during the review process with a focus
The following discussions will be on identifying the best practices by FDA
February 17, 2006 (see Registration). included:
Written or electronic comments will be and industry that facilitated that
• Current practices in the United process.
accepted until May 8, 2006 (see States and in foreign countries regarding
Comments). blood donor deferrals based on high-risk ADDRESSES: Submit written requests for
Addresses: The public workshop will behavior, single copies of this report to the Office
be held at the National Institutes of • Comparison of selected tissue donor of Planning (HFP–10), Food and Drug
Health, Lister Hill Auditorium, Bldg. deferral policies to blood donor deferral Administration, 5600 Fishers Lane,
erjones on PROD1PC68 with NOTICES
38A, 8600 Rockville Pike, Bethesda, MD policies, Rockville, MD 20857. Send one self-
20894. Submit written comments to the • Behavioral risks for transfusion- addressed adhesive label to assist that
Division of Dockets Management (HFA– transmitted diseases, office in processing your requests.
305), Food and Drug Administration, • Residual risks of infection from Submit electronic requests to
5630 Fishers Lane, rm. 1061, Rockville, transfusion, and Carolyn.Staples@fda.hhs.gov. This
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Federal Register / Vol. 71, No. 25 / Tuesday, February 7, 2006 / Notices 6285
report will be available on FDA’s Web DEPARTMENT OF HEALTH AND ACTION: Request for applications.
site at a later date. HUMAN SERVICES
SUMMARY: The Coast Guard seeks
FOR FURTHER INFORMATION CONTACT: Substance Abuse and Mental Health applications for membership on the
Carolyn Staples, Office of Planning Services Administration Towing Safety Advisory Committee
(HFP–10), Food and Drug (TSAC). TSAC advises the Coast Guard
Administration, 5600 Fishers Lane, Center for Substance Abuse on matters relating to shallow-draft
Rockville, MD 20857, 301–827–5274, or Prevention; Notice of Meeting inland and coastal waterway navigation
William Hagan, Office of Planning and towing safety.
Pursuant to Public Law 92–463,
(HFP–1), Food and Drug DATES: Application forms should reach
notice is hereby given of the meeting of
Administration, 5600 Fishers Lane, the SAMHSA Center for Substance us on or before April 30, 2006.
Rockville, MD 20857, 301–827–8816. Abuse Prevention (CSAP) National ADDRESSES: You may request an
SUPPLEMENTARY INFORMATION: Advisory Council on February 14, 2006. application form by writing to
The meeting will be open and will Commandant (G–PSO–1); U.S. Coast
I. Background include a Director’s Report; discussions Guard, Room 1210; 2100 Second Street,
related to National Outcome Measures; SW., Washington, DC 20593–0001; by
On June 12, 2002, the President
an update on SAMHSA’s Drug Free calling 202–267–0214; or by faxing 202–
signed into law the Public Health
Communities programs; and a panel 267–4570. Send your original completed
Security and Bioterrorism Preparedness presentation on the roles of Project and signed application in written form
and Response Act of 2002, which Officers, Grants Management staff and to the above street address. Be sure to
includes PDUFA III. In conjunction with Contracts Management staff. sign and include the short page that
the passage of PDUFA III, FDA agreed A roster of Council members may be allows us to keep political affiliation on
to certain performance goals and obtained either by accessing the file. This notice is available on the
procedures that were described in an SAMHSA Council Web site, http:// Internet at http://dms.dot.gov in docket
enclosure to a June 4, 2002, letter from www.samhsa.gov/council/csap/ USCG–2006–23795 and the application
the Secretary of Health and Human csapnac.aspx or by communicating with form is also available at http://
Services, Tommy Thompson, to the contact listed below. Substantive www.uscg.mil/hq/g-m/advisory/
Congress entitled ‘‘PDUFA program information, a summary of the index.htm. (Click on ‘‘ACM
Reauthorization Performance Goals and meeting, and the transcript for the open Application’’.)
Procedures’’ (PDUFA Goals and session will also be available on the
FOR FURTHER INFORMATION CONTACT: Mr.
Procedures). SAMHSA CSAP Council Web site as
Gerald Miante; Assistant Executive
One of the goals relates to FDA’s soon as possible after the meeting.
Director of TSAC, telephone 202–267–
performance of first cycle reviews of Attendance by the public will be limited
0214, fax 202–267–4570, or e-mail
to space available.
original NMEs for NDAs and BLAs gmiante@comdt.uscg.mil.
(PDUFA Goals and Procedures, section Committee Name: Substance Abuse and
Mental Health Services Administration, SUPPLEMENTARY INFORMATION: The
10). Related to this goal, FDA was to Towing Safety Advisory Committee
Center for Substance Abuse Prevention
retain an independent expert consultant National Advisory Council. (TSAC) is a Federal advisory committee
to undertake a study to evaluate issues Date/Time: Tuesday, February 14, 2006, 12 mandated by Congress and operates
associated with the agency’s conduct of p.m. to 5 p.m. under 5 U.S.C. App. 2, (Pub. L. 92–463,
first cycle reviews. The study was to Place: Washington DC Convention Center, 86 Stat. 770, as amended). It advises the
assess the following objectives: (1) 801 Mount Vernon Place, NW., Room 204 B, Secretary of Homeland Security on
Current first cycle review performance Washington, DC 20001.
Type: Open.
matters relating to shallow-draft inland
and any changes that occur after FDA and coastal waterway navigation and
Contact: Tia Haynes, Committee
publishes guidance on Good Review Management Specialist, 1 Choke Cherry towing safety. This advice also assists
Management Principles (GRMPs), (2) the Road, Room 4–1066, Rockville, Maryland the Coast Guard in formulating the
first cycle review history of all NDAs for 20857. Telephone: (240) 276–2436. Fax: (240) position of the United States in advance
new molecular entities and all BLAs 276–2430 E-mail: of meetings of the International
during PDUFA III, and (3) the Tia.haynes@samhsa.hhs.gov. Maritime Organization.
effectiveness of FDA’s staff training Dated: February 1, 2006. TSAC meets at least once a year at
regarding GRMPs. FDA awarded a Toian Vaughn, Coast Guard Headquarters, Washington,
contract to an independent expert to Committee Management Officer, Substance DC, or another location selected by the
study these issues. The report referred Abuse and Mental Health Services Coast Guard. It may also meet for
to in this document covers the Administration. extraordinary purposes. Its working
retrospective portion of objectives (1) [FR Doc. E6–1623 Filed 2–6–06; 8:45 am] groups may meet to consider specific
and (2) listed previously. BILLING CODE 4162–20–P
issues as required. The 16-person
membership includes 7 representatives
In accordance with the PDUFA goal, of the Barge and Towing Industry
the report is being made available to the (reflecting a regional geographical
public. DEPARTMENT OF HOMELAND
SECURITY balance); 1 member from the Offshore
Dated: January 30, 2006. Mineral and Oil Supply Vessel Industry;
Jeffrey Shuren, Coast Guard and 2 members from each of the
following areas: Maritime Labor;
erjones on PROD1PC68 with NOTICES
Assistant Commissioner for Policy. [USCG–2006–23795] Shippers (of whom at least one shall be
[FR Doc. E6–1605 Filed 2–6–06; 8:45 am]
Towing Safety Advisory Committee; engaged in the shipment of oil or
BILLING CODE 4160–01–S hazardous materials by barge); Port
Vacancies
Districts, Authorities, or Terminal
AGENCY: Coast Guard, DHS. Operators; and the General Public.
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