Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and Other Biological Products; Public Workshop, 41362-41363 [E8-16459]

Download as PDF 41362 Federal Register / Vol. 73, No. 139 / Friday, July 18, 2008 / Notices decomposition. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the draft CPG from FDA’s Office of Regulatory Affairs home page. It may be accessed at https:// www.fda.gov/ora under ‘‘Compliance Reference.’’ Dated: June 30, 2008. Margaret O’K. Glavin, Associate Commissioner for Regulatory Affairs. [FR Doc. E8–16453 Filed 7–17–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0038] Animal Models for the Treatment of Acute Radiation Syndrome; Public Workshop AGENCY: Food and Drug Administration, dwashington3 on PRODPC61 with NOTICES3 HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research, and the National Institutes of Health, National Institute of Allergy and Infectious VerDate Aug<31>2005 15:36 Jul 17, 2008 Jkt 214001 Diseases, are announcing a public workshop entitled ‘‘Animal Models for the Treatment of Acute Radiation Syndrome (ARS).’’ The purpose of the public workshop is to discuss issues that should be considered when developing animal models to assist in developing and demonstrating the efficacy of products intended for treatment of ARS. Date and Time: The public workshop will be held on September 17, 2008, from 8:30 a.m. to 5:30 p.m., and on September 18, 2008, from 8:30 a.m. to 1 p.m. Location: The public workshop will be held at the Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877. Contact Person: Bernadette Kawaley, Center for Biologics Evaluation and Research (HFM–43), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–2000, FAX: 301–827–3079; email: CBERTraining@fda.hhs.gov (Subject line: Animal Models for ARS Workshop). Registration: Mail, fax, or e-mail your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by August 25, 2008. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 8 a.m. If you need special accommodations due to a disability, please contact Bernadette Kawaley (see Contact Person) at least 7 days in advance. SUPPLEMENTARY INFORMATION: There are no approved medical products with an indication for treatment of ARS. The public workshop will provide the opportunity to explore current research involving animal models for the development of treatments for ARS, and to determine what areas need further research. There will be feature presentations by experts from government, academia, and medicine. The first day of the workshop will include presentations on the effects of radiation and the management of patients with ARS, and a discussion of the application of the animal rule to therapies for ARS. Both days of the workshop will examine the challenges faced when using animal models to mimic radiation exposure scenarios and will include panel discussions that will focus on various animal models and their application to the different syndromes of ARS. Please note that on January 15, 2008, the FDA Division of Dockets PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. Dated: July 11, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–16461 Filed 7–17–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0038] Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and Other Biological Products; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing a public workshop entitled ‘‘Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and Other Biological Products.’’ The purpose of the public workshop is to provide a forum on recent scientific and technical achievements in the development of rapid methods for mycoplasma testing during the manufacture of vaccines and other biological products. Such discussion may help to assess how these methods compare with currently used methods. Expedited manufacture may be of particular importance to public health during an influenza pandemic. Date and Time: The public workshop will be held on September 22, 2008, from 8:30 a.m. to 5 p.m., and September 23, 2008, from 8:30 a.m. to 12 noon. Location: The public workshop will be held at the Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877. Contact Person: Bernadette Kawaley, Center for Biologics Evaluation and Research (HFM–43), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448, 301–827– 2000, FAX: 301–827–3079, e-mail: CBERTraining@fda.hhs.gov (Subject line: Mycoplasma Workshop). E:\FR\FM\18JYN1.SGM 18JYN1 Federal Register / Vol. 73, No. 139 / Friday, July 18, 2008 / Notices Registration: Mail, fax, or e-mail your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by August 22, 2008. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. There will be no onsite registration. If you need special accommodations due to a disability, please contact Bernadette Kawaley (see Contact Person) at least 7 days in advance. Submit written abstracts to the contact person by August 15, 2008 (see section II of this document for additional information). SUPPLEMENTARY INFORMATION: dwashington3 on PRODPC61 with NOTICES3 I. Background FDA will explore the use of alternative methods for detecting mycoplasma contamination in the manufacture of vaccines, including pandemic influenza vaccines, and other biological products. Alternative methods that allow detection of mycoplasma in a shorter period, as compared to the current methods, could expedite the manufacture of vaccines and other biological products. The workshop is aimed at: (1) Identifying promising rapid method(s) for further validation to demonstrate equivalency or superiority to methods currently used for mycoplasma testing during the manufacture of vaccines and other biological products and (2) providing information that may lead to collaborative studies with FDA on testing for mycoplasma. The program agenda will be available at https:// www.fda.gov/cber/scireg.htm, by September 5, 2008. II. Submission of the Abstracts For purposes of discussion at the workshop, FDA is requesting submission of abstracts that describe current developments in rapid methods for detection of mycoplasma contamination during manufacture of vaccines and other biological products. FDA will select a limited number of abstracts for formal presentation at the workshop by the abstract authors. If time permits, FDA may allow additional presentations from interested persons attending the meeting who did not submit an abstract. FDA will notify authors of abstracts accepted for presentation at the workshop by August 25, 2008. Abstracts should be a maximum of 350 words, printed (typewritten or computer) and double-spaced. The title should be brief and capitalized. The authors name(s), contact information, VerDate Aug<31>2005 15:36 Jul 17, 2008 Jkt 214001 and agency, institution, or facility involved should be listed. The author who intends to present the abstract should submit a current curriculum vitae with the abstract. Dated: July 11, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–16459 Filed 7–17–08; 8:45 am] BILLING CODE 4160–01–S 41363 label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG. FOR FURTHER INFORMATION CONTACT: Robert J. Moore, Center for Food Safety and Applied Nutrition (HFS–810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2375. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of September 23, 1997 (62 FR 49868), FDA issued a final rule amending its regulations to: Food and Drug Administration Define the term ‘‘high potency’’ as a nutrient content claim; define nutrient [Docket No. FDA–1995–N–0400 (formerly Docket No. 1995N–0245), FDA–1995–N–0029 content claims using the term ‘‘antioxidant’’ (e.g., ‘‘good source of (formerly Docket No. 1995N–0282), FDA– antioxidants,’’ ‘‘high in antioxidants,’’ 1995–N–0224 (formerly Docket No. 1995N– 0347)] ‘‘more antioxidants’’) and to correct an omission pertaining to the use of ‘‘sugar Small Entity Compliance Guide: Food free’’ claims on dietary supplements. Labeling; Nutrient Content Claims: This final rule became effective March Definition for ‘‘High Potency’’ and 23, 1999.1 Definition of ‘‘Antioxidant’’ for Use in FDA examined the economic Nutrient Content Claims for Dietary implementation of the final rule as Supplements and Conventional Foods; required by the Regulatory Flexibility Availability Act (5 U.S.C. 601–602) and determined AGENCY: Food and Drug Administration, that the final rule might have a significant economic impact on a HHS. substantial number of small entities. In ACTION: Notice. compliance with section 212 of the SUMMARY: The Food and Drug Small Business Regulatory Enforcement Administration (FDA) is announcing the Fairness Act (Public Law 104–121), FDA availability of a small entity compliance is making available this SECG stating in guide (SECG) for a final rule published plain language the requirements of the in the Federal Register of September 23, regulation. 1997, entitled ‘‘Food Labeling; Nutrient FDA is issuing this SECG as level 2 Content Claims; Definition for ‘‘High guidance consistent with FDA’s good Potency’’ and Definition of guidance practices regulation (21 CFR ‘‘Antioxidant’’ for Use in Nutrient 10.115(c)(2)). The SECG represents the Content Claims for Dietary Supplements agency’s current thinking on this and Conventional Foods.’’ This SECG is subject. It does not create or confer any intended to set forth in plain language rights for or on any person and does not the requirements of the regulation and operate to bind FDA or the public. An to help small businesses understand the alternative approach may be used if regulation. such approach satisfies the requirements of the applicable statutes DATES: Submit written or electronic and regulations. comments on the SECG at any time. ADDRESSES: Submit written comments II. Comments on the SECG to the Division of Dockets Interested persons may submit to the Management (HFA–305), Food and Drug Division of Dockets Management (see Administration, 5630 Fishers Lane, rm. ADDRESSES) written or electronic 1061, Rockville, MD 20852. Submit comments regarding this SECG. Submit electronic comments on the SECG to a single copy of electronic comments or https://www.regulations.gov. Submit two paper copies of any mailed written requests for single copies of the comments, except that individuals may SECG to the Division of Dietary submit one paper copy. Comments are Supplement Programs, Office of to be identified with the docket number Nutrition, Labeling, and Dietary found in brackets in the heading of this Supplements (HFS–810), Center for document. The SECG and received Food Safety and Applied Nutrition, Food and Drug Administration, 5100 1 FDA published a correction to the final rule in Paint Branch Pkwy., College Park, MD the Federal Register of October 24, 1997 (62 FR 20740, or fax your request to 301–436– 55331). The correction was to correct a RIN number 2639. Send one self-addressed adhesive that appeared in the September 23, 1997, final rule. DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\18JYN1.SGM 18JYN1

Agencies

[Federal Register Volume 73, Number 139 (Friday, July 18, 2008)]
[Notices]
[Pages 41362-41363]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16459]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]


Rapid Methods for Detecting Mycoplasma Contamination in the 
Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and 
Other Biological Products; Public Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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

    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Rapid Methods for Detecting Mycoplasma 
Contamination in the Manufacture of Vaccines, Including Pandemic 
Influenza Vaccines, and Other Biological Products.'' The purpose of the 
public workshop is to provide a forum on recent scientific and 
technical achievements in the development of rapid methods for 
mycoplasma testing during the manufacture of vaccines and other 
biological products. Such discussion may help to assess how these 
methods compare with currently used methods. Expedited manufacture may 
be of particular importance to public health during an influenza 
pandemic.
    Date and Time: The public workshop will be held on September 22, 
2008, from 8:30 a.m. to 5 p.m., and September 23, 2008, from 8:30 a.m. 
to 12 noon.
    Location: The public workshop will be held at the Hilton Washington 
DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.
    Contact Person: Bernadette Kawaley, Center for Biologics Evaluation 
and Research (HFM-43), Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852-1448, 301-827-2000, FAX: 301-827-3079, e-
mail: CBERTraining@fda.hhs.gov (Subject line: Mycoplasma Workshop).

[[Page 41363]]

    Registration: Mail, fax, or e-mail your registration information 
(including name, title, firm name, address, telephone and fax numbers) 
to the contact person by August 22, 2008. There is no registration fee 
for the public workshop. Early registration is recommended because 
seating is limited. There will be no onsite registration.
    If you need special accommodations due to a disability, please 
contact Bernadette Kawaley (see Contact Person) at least 7 days in 
advance.
    Submit written abstracts to the contact person by August 15, 2008 
(see section II of this document for additional information).

SUPPLEMENTARY INFORMATION:

I. Background

    FDA will explore the use of alternative methods for detecting 
mycoplasma contamination in the manufacture of vaccines, including 
pandemic influenza vaccines, and other biological products. Alternative 
methods that allow detection of mycoplasma in a shorter period, as 
compared to the current methods, could expedite the manufacture of 
vaccines and other biological products. The workshop is aimed at: (1) 
Identifying promising rapid method(s) for further validation to 
demonstrate equivalency or superiority to methods currently used for 
mycoplasma testing during the manufacture of vaccines and other 
biological products and (2) providing information that may lead to 
collaborative studies with FDA on testing for mycoplasma. The program 
agenda will be available at https://www.fda.gov/cber/scireg.htm, by 
September 5, 2008.

II. Submission of the Abstracts

    For purposes of discussion at the workshop, FDA is requesting 
submission of abstracts that describe current developments in rapid 
methods for detection of mycoplasma contamination during manufacture of 
vaccines and other biological products. FDA will select a limited 
number of abstracts for formal presentation at the workshop by the 
abstract authors. If time permits, FDA may allow additional 
presentations from interested persons attending the meeting who did not 
submit an abstract. FDA will notify authors of abstracts accepted for 
presentation at the workshop by August 25, 2008.
    Abstracts should be a maximum of 350 words, printed (typewritten or 
computer) and double-spaced. The title should be brief and capitalized. 
The authors name(s), contact information, and agency, institution, or 
facility involved should be listed. The author who intends to present 
the abstract should submit a current curriculum vitae with the 
abstract.

    Dated: July 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16459 Filed 7-17-08; 8:45 am]
BILLING CODE 4160-01-S

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