[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Pages 71045-71046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29483]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0599]
Center for Biologics Evaluation and Research Report of Scientific
and Medical Literature and Information on Non-Standardized Allergenic
Extracts in the Diagnosis and Treatment of Allergic Disease; Extension
of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is extending to April
25, 2012, the comment period for the notice on its report of scientific
and medical literature and information concerning the use of non-
standardized allergenic extracts in the diagnosis and treatment of
allergic disease that appeared in the Federal Register of September 26,
2011 (76 FR 59407). In the notice, FDA requested comments from public
and private stakeholders on
[[Page 71046]]
the report it provided in a data file entitled ``Center for Biologics
Evaluation and Research Report of Scientific and Medical Literature and
Information on Non-Standardized Allergenic Extracts in the Diagnosis
and Treatment of Allergic Disease.'' The Agency is taking this action
in response to input it received from the Allergenic Products Advisory
Committee (APAC) at a meeting held on October 25, 2011, to allow
interested persons additional time to submit comments.
DATES: Submit either electronic or written comments on the report by
April 25, 2012.
ADDRESSES: Submit written requests for single copies of the report to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The data file may also be obtained by mail by
calling CBER at 1-(800) 835-4709 or (301) 827-1800. See the
SUPPLEMENTARY INFORMATION section for electronic access to the data
file document.
Submit electronic comments on the report to http://www.regulations.gov. Submit written comments on the report to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, (301) 827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 26, 2011 (76 FR 59407), FDA
published a notice with a 60-day comment period to request comments on
its report of scientific and medical literature and information
concerning the use of non-standardized allergenic extracts in the
diagnosis and treatment of allergic disease. Comments on the report
will allow FDA to fully evaluate the information contained in the
report.
The Agency received comments in the APAC meeting held on October
25, 2011, that FDA should consider extending the comment period for the
notice for several months. Members of the APAC expressed concern that
the current 60-day comment period does not allow sufficient time to
develop a meaningful or thoughtful response to the notice on FDA's
report of scientific and medical literature and information concerning
the use of non-standardized allergenic extracts in the diagnosis and
treatment of allergic disease. Materials related to the report were
discussed at this meeting and are available at: http:// www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/AllergenicProductsAdvisoryCommittee/ucm247212.htm. When it is completed, a transcript of the meeting will
also be available at this Web page.
FDA has considered the comments from the APAC meeting and is
extending the comment period for the notice until April 25, 2012. The
Agency believes that an extension until April 25, 2012, allows adequate
time for interested persons to submit comments without significantly
delaying the evaluation of these important issues.
FDA welcomes comments regarding its report of scientific and
medical literature and information concerning the use of non-
standardized allergenic extracts in the diagnosis and treatment of
allergic disease. In particular, FDA is interested in additional data
regarding the use of these extracts that had been previously published
in the medical or scientific literature. Unpublished data should
include the following information, if available: Date(s) of collection;
extract(s) studied and method of preparation; dose and route of
administration; patient demography; and additional clinical information
(including confirmatory testing, such as challenges or serum specific
IgE determinations).
II. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: November 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29483 Filed 11-15-11; 8:45 am]
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