Document ID: FDA-2011-N-0599-0002
Agency: fda
Document Type: Notice
Title: Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts, etc.: Center for Biologics Evaluation and Research; Extension of Comment Period
Posted Date: 2011-11-16T05:00Z

[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Pages 71045-71046]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29483]

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

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.

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

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]
BILLING CODE 4160-01-P