[Federal Register Volume 76, Number 186 (Monday, September 26, 2011)]
[Notices]
[Pages 59407-59408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-24598]


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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; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of 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. The report is 
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.'' FDA is making this report available to provide 
information and obtain comments from public and private stakeholders. 
FDA will also seek input on the report from the Allergenic Products 
Advisory Committee (APAC) at a meeting to be held on October 25, 2011. 
FDA has not made any regulatory decisions concerning the report or the 
products discussed in the scientific literature and information cited. 
FDA will review comments and other information it receives, as part of 
its continued oversight of regulated products.

DATES: Submit either electronic or written comments on the report by 
November 25, 2011.

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

[[Page 59408]]

(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. Introduction

    FDA is announcing the availability of 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. FDA is making this report available to provide 
information and obtain comment on the report from public and private 
stakeholders. FDA will also seek input on the report from APAC at a 
meeting to be held on October 25, 2011. A separate notice of the APAC 
meeting is published elsewhere in this issue of the Federal Register. 
This process will assist FDA in its continued oversight of regulated 
products.

II. Discussion

    In 2004, FDA formed an internal committee to review available 
scientific and medical data on the safety and effectiveness of non-
standardized allergenic extracts. FDA formed this committee to consider 
the previous evaluations performed by the external allergenics advisory 
review panels under 21 CFR 601.25 (Panel I or ``Original Panel'') and 
under 21 CFR 601.26 (Panel II or ``Reclassification Panel''). Reports 
of the Original and Reclassification Panels are available at http://www.fda.gov/BiologicsBloodVaccines/Allergenics/ucm272115.htm. The 
internal committee designed a data file to use in its review and to 
archive supporting data. The data file includes a report of information 
for each product, including a discussion of each product reviewed, and 
a list of reviewed literature associated with each product. FDA's 
approach to creating this data file was presented to APAC on April 7, 
2005, and discussed again at the APAC meeting on September 13, 2006.
    After receiving favorable feedback from the APAC on FDA's proposed 
methodology, FDA proceeded to collect the following information in 
order to facilitate its assessment of safety and effectiveness of non-
standardized allergenic products.

A. Literature Reviewed by the Allergenics Advisory Review Panels

    This includes literature reviewed by the Original Panel as part of 
its final report in 1981 and literature reviewed by the 
Reclassification Panel as part of its final report in 1983.

B. Data Concerning the Effectiveness and Safety of Non-Standardized 
Allergenic Products That Have Become Available Since 1972

    This includes published literature, available manufacturer data, 
and data from other external sources. FDA accumulated these data from 
the following sources:
1. Published Literature From 1972 to the Present
    This literature was acquired by searching for articles using a 
PubMed and/or Institute for Scientific Information (ISI) search engine 
(English-language literature articles only).
2. Publicly Available Manufacturer Data
    These data were obtained by reviewing information published in the 
literature.
3. Medwatch Data Collected for Years 1987 to 2010
    These data were evaluated for safety related product trends.
4. Data From Other External Sources
    These data were obtained by performing a broad Internet search 
(e.g., Google) to check for any additional safety or effectiveness data 
not captured in published articles found via PubMed or ISI.
    FDA collected information from published scientific and medical 
literature and other data sources for each extract in order to identify 
those studies that used acceptable alternative testing methods. FDA 
also collected information from studies that:
     Provided identifiable, specific and valid nomenclature for 
the source materials used in the preparation of the allergenic extracts 
in the studies.
     Were performed using aqueous based extracts prepared from 
specifically identified source materials with correct nomenclature.
     Described identifiable, specific, and valid study methods.
     Provided objective and evaluable data.
     For skin test data in the studies:
    Obtained positive skin tests in index cases by either skin prick or 
intradermal methods, demonstrated by:
    [cir] Wheal or erythema;
    [cir] Where appropriate, comparison to positive and negative 
control data in same study subjects.
     For studies with cross reactivity data, demonstrated cross 
reactivity by:
    [cir] ELISA or RAST inhibition;
    [cir] Western immunoblot; or
    [cir] Other valid immunochemical data.
    In reviewing evidence of efficacy, FDA did not consider to be 
adequate ``random experience,'' or reports that lacked sufficient 
scientific detail for proper evaluation (such as imprecise 
nomenclature). FDA also did not consider to be adequate ``isolated case 
reports'' unless corroborated by the following: (1) Other case reports 
from independent authors, (2) well-described allergen challenge data, 
or (3) valid cross-reactivity data.
    FDA is providing its report of the collected literature and other 
data in a data file that is currently available in PDF format on FDA's 
Web site at http://www.fda.gov/downloads/BiologicsBloodVaccines/Allergenics/UCM271330.pdf. FDA welcomes comments on the scientific and 
medical literature and information presented in the data file.

III. 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the data file at 
http://www.fda.gov/downloads/BiologicsBloodVaccines/Allergenics/UCM271330.pdf or http://www.regulations.gov.

    Dated: September 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24598 Filed 9-23-11; 8:45 am]
BILLING CODE 4160-01-P