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Federal Register / Vol. 71, No.

30 / Tuesday, February 14, 2006 / Notices 7779

register to attend or present at the that suggest measures that could prevent ADDRESSES) written or electronic
workshop. You must register by close of or mitigate them? comments regarding this document.
business on April 15, 2006, to attend or 3. How does our current Submit a single copy of electronic
participate. understanding of the pathophysiology comments or two paper copies of any
We are opening a docket to receive and risk factors associated with these mailed comments, except that
your written or electronic comments infections inform future research and individuals may submit one paper copy.
(see ADDRESSES). Written or electronic public health actions? Comments should be identified with the
comments must be submitted to the 4. What are the gaps in basic research docket number found in brackets in the
docket by June 15, 2006. that are critical to a better heading of this document. Received
ADDRESSES: The public workshop will understanding of the pathogenesis of C. comments may be seen in the Division
be held at the Centers for Disease sordellii and C. difficile? of Dockets Management between 9 a.m.
Control and Prevention, 1600 Clifton III. How Do You Register? and 4 p.m., Monday through Friday. To
Rd., NE., CDC Roybal Campus, Bldg. 19, ensure consideration of your comments,
Auditorium A, Atlanta, GA 30333. Registration is required to attend or we must receive any written or
Submit written comments to Division participate in the workshop. Your electronic comments by the date
of Dockets Management (HFA–305), registration must be received by the indicated (see DATES).
Food and Drug Administration, 5630 close of business on April 15, 2006.
Registration is free. Seats are limited, so V. Will Meeting Transcripts Be
Fishers Lane, rm. 1061, Rockville, MD
please register as soon as possible. Available?
20852. Submit electronic comments to Space will be filled in order of receipt You can examine a transcript of the
FOR FURTHER INFORMATION CONTACT: of registration. Those registered will May 11, 2006, public workshop on the
Workshop Coordinator, Center for Drug receive confirmation on April 18, 2006. Internet at http://
Evaluation and Research (HFD–006), Registration will close after available
Food and Drug Administration, 5600 space fills. You will not be notified if leaving.cq approximately 30 days after
Fishers Lane, Rockville, MD 20857, registration has closed before your the workshop or at the Division of
301–594–6779, FAX: 301–827–4312, e- registration is received. There will be no Dockets Management (see ADDRESSES),
mail: on-site registration the day of the Monday through Friday between 9 a.m.
workshop. and 4 p.m. You may also request a copy
Time will be allowed during the of the transcript from the Freedom of
I. Why Are We Holding a Public scheduled agenda for attendees to ask Information Office (HFI–35), Food and
Workshop? questions of panelists, to participate in Drug Administration, 5600 Fishers
This workshop has been developed in the discussion, and to provide input to Lane, rm. 12A–16, Rockville, MD 20857,
response to reports of morbidity and the sponsoring agencies on future approximately 15 working days after the
mortality associated with C. sordellii research, surveillance, and case public workshop at a cost of 10 cents
and C. difficile. These reports include detection. In addition, we strongly per page.
cases and clusters of C. sordellii toxic encourage written submissions to the Dated: February 9, 2006.
shock syndrome following treatment docket. Jeffrey Shuren,
with mifepristone, C. sordellii sepsis If you need special accommodations
Assistant Commissioner for Policy.
associated with tissue grafts, and due to disability, please contact the
Workshop Coordinator (see FOR FURTHER [FR Doc. 06–1371 Filed 2–10–06; 11:33 am]
rapidly fatal toxin-mediated cases of BILLING CODE 4160–01–S
community-associated C. difficile INFORMATION CONTACT) at least 7 days in
infection. The primary goal of the advance of the workshop.
workshop is to bring together scientific Registration Form Instructions: To
register to attend the workshop, DEPARTMENT OF HEALTH AND
and public health experts to develop a HUMAN SERVICES
draft research agenda. This research complete the following registration form
agenda is expected to lead to better and submit via: Food and Drug Administration
understanding of the virulence, • E-mail:;
pathogenesis, host factors, and • FAX: 301–827–4312; or [Docket No. 2000D–1400]
• Mail to: Food and Drug
nonantimicrobial risk factors Guidance for Industry: Considerations
Administration, Center for Drug
contributing to these reports and to for Developmental Toxicity Studies for
Evaluation and Research, Office of
identify research needs and priorities in Preventive and Therapeutic Vaccines
Executive Programs, Executive
these areas. As part of a research for Infectious Disease Indications;
agenda, the workshop will assist in the Operations Staff (HFD–006), 5600
Fishers Lane, Rockville, MD 20857, Availability
development of recommendations for
detecting cases and conducting Attn: Workshop Coordinator. AGENCY: Food and Drug Administration,
Name: ____________________________ HHS.
surveillance. The meeting focus will be Company Name: ___________________
on increasing our understanding of Mailing Address: __________________ ACTION: Notice.
severe community associated C. difficile City: _________________ State: ______
and C. sordellii disease and of disease in SUMMARY: The Food and Drug
Zip Code: ________
otherwise healthy populations Phone: ( ) ________________ Administration (FDA) is announcing the
previously thought to be at low risk. Fax: ( ) ___________________ availability of a document entitled
E-mail: ( ) ________________ ‘‘Guidance for Industry: Considerations
II. What Are the Issues We Intend to U.S. Citizen Yes/No (Required by CDC for Developmental Toxicity Studies for
Address at the Workshop? Preventive and Therapeutic Vaccines for
rmajette on PROD1PC67 with NOTICES

1. What clinical and laboratory Infectious Disease Indications,’’ dated
surveillance data are needed to help IV. How Should You Send Comments February 2006. The guidance is
guide infection prevention? on the Issues? intended to provide sponsors with
2. Are there characteristics of the Interested persons may submit to the recommendations for the conduct of
clinical presentations of these infections Division of Dockets Management (see developmental toxicity studies for

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7780 Federal Register / Vol. 71, No. 30 / Tuesday, February 14, 2006 / Notices

investigational preventive and Industry: Considerations for Dated: February 1, 2006.

therapeutic vaccines for infectious Reproductive Toxicity Studies for Jeffrey Shuren,
disease indications. The Preventive Vaccines for Infectious Assistant Commissioner for Policy.
recommendations pertain to the Disease Indications,’’ dated August 2000 [FR Doc. E6–1998 Filed 2–13–06; 8:45 am]
assessment of the developmental (65 FR 54534, September 8, 2000). The BILLING CODE 4160–01–S
toxicity potential of preventive and guidance was revised based on public
therapeutic vaccines for infectious comments submitted to the Division of
diseases indicated for females of Dockets Management on the draft DEPARTMENT OF HEALTH AND
childbearing potential and pregnant guidance, and on recommendations HUMAN SERVICES
individuals. This guidance document
made by an expert panel convened at a
finalizes the draft guidance entitled National Institutes of Health
workshop entitled ‘‘Non-Clinical Safety
‘‘Guidance for Industry: Considerations
for Reproductive Toxicity Studies for Evaluation of Preventive Vaccines: Proposed Collection; Comment
Preventive Vaccines for Infectious Recent Advances and Regulatory Request, Fogarty International Center
Disease Indications,’’ dated August Considerations’’ held December 2 and 3, CareerTrac
2000. 2002, Arlington, VA.
SUMMARY: In compliance with the
DATES: Submit written or electronic The guidance is being issued requirement of Section 3506(c)(2)(A) of
comments on agency guidances at any consistent with FDA’s good guidance the Paperwork Reduction Act of 1995,
time. practices regulation (21 CFR 10.115). for opportunity for public comment on
The guidance represents the agency’s proposed data collection projects, the
ADDRESSES: Submit written requests for
single copies of the guidance to the current thinking on this topic. It does Fogarty International Center, the
Office of Communication, Training, and not create or confer any rights for or on National Institutes of Health (NIH) will
Manufacturers Assistance (HFM–40), any person and does not operate to bind publish periodic summaries of proposed
Center for Biologics Evaluation and FDA or the public. An alternative projects to be submitted to the Office of
Research (CBER), Food and Drug approach may be used if such approach Management and Budget (OMB) for
Administration, 1401 Rockville Pike, satisfies the requirements of the review and approval.
suite 200N, Rockville, MD 20852–1448. applicable statutes and regulations.
Proposed Collection
Send one self-addressed adhesive label
II. Paperwork Reduction Act of 1995 Title: Fogarty International Center
to assist the office in processing your
requests. The guidance may also be This guidance refers to previously CareerTrac.
obtained by mail by calling CBER at 1– approved collections of information Type of Information Collection
800–835–4709 or 301–827–1800. See Request: NEW.
found in FDA regulations. These
the SUPPLEMENTARY INFORMATION section Need and Use of Information
collections of information are subject to
for electronic access to the guidance Collection: This data collection system
review by the Office of Management and
document. is being developed to track, evaluate
Budget (OMB) under the Paperwork and report short and long-term output,
Submit written comments on the
guidance to the Division of Dockets Reduction Act of 1995 (44 U.S.C. 3501– outcomes and impacts of international
Management (HFA–305), Food and Drug 3520). The collection of information in trainees involved in health research
Administration, 5630 Fishers Lane, rm. this guidance for 21 CFR 601.2 has been training programs—specifically tracking
1061, Rockville, MD 20852. Submit approved under OMB control number this for at least ten years following
electronic comments to http:// 0910–0338. training. The data collection system III. Comments provides a streamlined, Web-based
FOR FURTHER INFORMATION CONTACT: application permitting principal
Astrid Szeto, Center for Biologics Interested persons may, at any time, investigators to record career
Evaluation and Research (HFM–17), submit written or electronic comments achievement progress by trainee on a
Food and Drug Administration, 1401 to the Division of Dockets Management voluntary basis. FIC Program Managers
Rockville Pike, suite 200N, Rockville, (see ADDRESSES) regarding this will use this data to monitor, evaluate
MD 20852–1448, 301–827–6210. guidance. Submit a single copy of and adjust grants to ensure desired
SUPPLEMENTARY INFORMATION: electronic comments or two paper outcomes are achieved, comply with
copies of any mailed comments, except OMB Part requirements for managing
I. Background grants, respond to congressional
that individuals may submit one paper
FDA is announcing the availability of copy. Comments are to be identified inquiries, and as a guide to in future
a document entitled ‘‘Guidance for with the docket number found in the strategic and management decisions
Industry: Considerations for regarding the grants training program.
brackets in the heading of this
Developmental Toxicity Studies for Frequency of Response: Annual and
document. A copy of the guidance and
Preventive and Therapeutic Vaccines for periodic.
received comments are available for Affected Public: none.
Infectious Disease Indications,’’ dated
public examination in the Division of Type of Respondents: Principal
February 2006. The guidance document
provides sponsors with Dockets Management between 9 a.m. Investigators funded by Fogarty
recommendations for the conduct and and 4 p.m., Monday through Friday. International Center.
assessment of developmental toxicity III. Electronic Access The annual reporting burden is as
studies for investigational preventive follows:
and therapeutic vaccines for infectious Persons with access to the Internet Estimated Number of Respondents:
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diseases indicated for women of may obtain the guidance at either http:// 150;
childbearing potential and pregnant or Estimated Number of Responses per
women. Respondent: 15;
This guidance document finalizes the default.htm. Average Burden Hours per Response:
draft guidance entitled ‘‘Guidance for .50; and

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