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Federal Register / Vol. 71, No.

47 / Friday, March 10, 2006 / Notices 12367

and is not intended for implementation guidance. General comments on agency practices regulation (21 CFR 10.115).
at this time. Interested persons may guidance documents are welcome at any The draft guidance, when finalized, will
submit to the Division of Dockets time. represent FDA’s current thinking on this
Management (see ADDRESSES) written or ADDRESSES: Submit written requests for topic. It does not create or confer any
electronic comments regarding the draft single copies of the draft guidance to the rights for or on any person and does not
guidance. Submit a single copy of Office of Communication, Training, and operate to bind FDA or the public. An
electronic comments or two paper Manufacturers Assistance (HFM–40), alternative approach may be used if
copies of any mailed comments, except Center for Biologics Evaluation and such approach satisfies the requirement
that individuals may submit one paper Research (CBER), Food and Drug of the applicable statutes and
copy. Comments are to be identified Administration, 1401 Rockville Pike, regulations.
with the docket number found in suite 200N, Rockville, MD 20852–1448. II. Paperwork Reduction Act of 1995
brackets in the heading of this Send one self-addressed adhesive label
document. A copy of the draft guidance to assist the office in processing your This draft guidance refers to
and received comments are available for requests. The draft guidance may also be previously approved collections of
public examination in the Division of obtained by mail by calling CBER at 1– information found in FDA regulations.
Dockets Management between 9 a.m. 800–835–4709 or 301–827–1800. See These collections of information are
and 4 p.m., Monday through Friday. the SUPPLEMENTARY INFORMATION section subject to review by the Office of
for electronic access to the draft Management and Budget (OMB) under
IV. Electronic Access the Paperwork Reduction Act of 1995
guidance document.
Persons with access to the Internet Submit written comments on the draft (44 U.S.C. 3501–3520). The information
may obtain the draft guidance at either guidance to the Division of Dockets collection provisions in this guidance
http://www.fda.gov/cber/guidelines.htm Management (HFA–305), Food and Drug for 21 CFR part 601 have been approved
or http://www.fda.gov/ohrms/dockets/ Administration, 5630 Fishers Lane, rm. under OMB control number 0910–0338.
default.htm. 1061, Rockville, MD 20852. Submit III. Comments
Dated: March 1, 2006. electronic comments to http://
www.fda.gov/dockets/ecomments. The draft guidance is being
Jeffrey Shuren, distributed for comment purposes only
Assistant Commissioner for Policy. FOR FURTHER INFORMATION CONTACT:
and is not intended for implementation
[FR Doc. E6–3371 Filed 3–9–06; 8:45 am] Valerie A. Butler, Center for Biologics at this time. Interested persons may
BILLING CODE 4160–01–S
Evaluation and Research (HFM–17), submit to the Division of Dockets
Food and Drug Administration, 1401 Management (see ADDRESSES) written or
Rockville Pike, suite 200N, Rockville, electronic comments regarding the draft
DEPARTMENT OF HEALTH AND MD 20852–1448, 301–827–6210. guidance. Submit a single copy of
HUMAN SERVICES SUPPLEMENTARY INFORMATION: electronic comments or two paper
I. Background copies of any mailed comments, except
Food and Drug Administration that individuals may submit one paper
[Docket No. 2006D–0083]
FDA is announcing the availability of copy. Comments are to be identified
a draft document entitled ‘‘Guidance for with the docket number found in the
Draft Guidance for Industry on Clinical Industry: Clinical Data Needed to brackets in the heading of this
Data Needed to Support the Licensure Support the Licensure of Trivalent document. A copy of the draft guidance
of Trivalent Inactivated Influenza Inactivated Influenza Vaccines,’’ dated and received comments are available for
Vaccines; Availability March 2006. The draft guidance is public examination in the Division of
intended to provide to sponsors of Dockets Management between 9 a.m.
AGENCY: Food and Drug Administration, trivalent inactivated influenza vaccines
HHS. and 4 p.m., Monday through Friday.
guidance on the clinical data needed to
ACTION: Notice. support a BLA. The draft guidance IV. Electronic Access
summarizes clinical development Persons with access to the Internet
SUMMARY: The Food and Drug approaches to facilitate and expedite the may obtain the draft guidance at either
Administration (FDA) is announcing the licensure of new ‘‘split virus’’ trivalent http://www.fda.gov/cber/guidelines.htm
availability of a draft document entitled inactivated influenza vaccines and or http://www.fda.gov/ohrms/dockets/
‘‘Guidance for Industry: Clinical Data addresses both traditional and default.htm.
Needed to Support the Licensure of accelerated approval. The approaches
Trivalent Inactivated Influenza Dated: February 28, 2006.
are also applicable to vaccines made
Vaccines,’’ dated March 2006. The draft with other manufacturing processes; Jeffrey Shuren,
guidance document is intended to e.g., whole virus inactivated, cell- Assistant Commissioner for Policy.
provide to sponsors of trivalent culture based inactivated, recombinant [FR Doc. E6–3370 Filed 3–9–06; 8:45 am]
inactivated influenza vaccines guidance protein, and adjuvanted influenza BILLING CODE 4160–01–S
on the clinical data needed to support vaccines. The draft guidance does not
a Biologics License Application (BLA). address live attenuated influenza
The draft guidance summarizes clinical vaccines or influenza vaccines that do DEPARTMENT OF HEALTH AND
development approaches to facilitate not contain a hemagglutinin component. HUMAN SERVICES
and expedite the licensure of new The draft guidance also does not
Health Resources and Services
dsatterwhite on PROD1PC65 with PROPOSAL

trivalent inactivated influenza vaccines address the nonclinical development of


and addresses both traditional and investigational vaccines, or the Administration
accelerated approval. chemistry, manufacturing, control, or National Practitioner Data Bank:
DATES: Submit written or electronic inspection of the manufacturing facility Change in User Fees
comments on the draft guidance by June needed for licensure.
8, 2006 to ensure their adequate The draft guidance is being issued AGENCY:Health Resources and Services
consideration in preparation of the final consistent with FDA’s good guidance Administration, HHS.

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