[Federal Register Volume 77, Number 72 (Friday, April 13, 2012)]
[Notices]
[Pages 22282-22283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8908]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0022]


Draft Guidelines on Biologics Quality Monitoring: Testing for the 
Detection of Mycoplasma Contamination

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability and request for comments.

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SUMMARY: The International Cooperation on Harmonization of Technical 
Requirements for the Registration of Veterinary Medicinal Products 
(VICH) has developed a draft guideline titled ``Testing for the 
Detection of Mycoplasma Contamination.'' This draft guideline 
identifies stages of manufacture where products are to be tested and 
test procedures used to detect

[[Page 22283]]

the presence of Mycoplasma contamination. Because the guidelines apply 
to final product and master seed/cell testing in veterinary vaccines 
regulated by the Animal and Plant Health Inspection Service under the 
Virus-Serum-Toxin Act, we are requesting comments on the scope of the 
guideline and its provisions so that we may include any relevant public 
input on the draft in the Agency's comments to the VICH Steering 
Committee.

DATES: We will consider all comments that we receive on or before June 
12, 2012.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2012-0022-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2012-0022, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-
0022 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Donna L. Malloy, Section Leader, 
Operational Support, Center for Veterinary Biologics, Policy, 
Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148, 
Riverdale Maryland 20737-1231; (301) 851-3426.

SUPPLEMENTARY INFORMATION: The International Cooperation on 
Harmonization of Technical Requirements for the Registration of 
Veterinary Medicinal Products (VICH) is a unique project conducted 
under the auspices of the World Organization for Animal Health that 
brings together the regulatory authorities of the European Union, 
Japan, and the United States and representatives from the animal health 
industry in the three regions. The purpose of VICH is to harmonize 
technical requirements for veterinary products (both drugs and 
biologics). Regulatory authorities and industry experts from Australia 
and New Zealand participate in an observer capacity. The World 
Federation of the Animal Health Industry (COMISA, the Confederation 
Mondiale de L'Industrie de la Sante Animale) provides the secretarial 
and administrative support for VICH activities.
    The United States Government is represented in VICH by the Food and 
Drug Administration (FDA) and the Animal and Plant Health Inspection 
Service (APHIS). The FDA provides expertise on veterinary drugs, while 
APHIS fills a corresponding role for veterinary biological products. As 
VICH members, APHIS and FDA participate in efforts to enhance 
harmonization and have expressed their commitment to seeking 
scientifically based, harmonized technical requirements for the 
development of veterinary drugs and biological products. One of the 
goals of harmonization is to identify and reduce the differences in 
technical requirements for veterinary drugs and biologics among 
regulatory agencies in different countries.
    The draft guideline ``Testing for the Detection of Mycoplasma 
Contamination'' (VICH Topic GL34) has been made available by the VICH 
Steering Committee for comments by interested parties. Mycoplasma 
contaminants may be introduced into cell culture and in ovo origin 
biological products through the master seeds, the master cell seed 
(stock), starting materials of animal origin, and in processing of 
biological materials during passage and product assembly. Therefore, it 
is necessary to demonstrate through testing that Mycoplasmas are not 
present, within the limits of the test, in the final product, working 
seeds and cells and harvests, and starting materials such as the master 
seed, master cell seed, and ingredients of animal origin. The draft 
guideline establishes stages of manufacture to be tested and test 
procedures to detect the presence of Mycoplasma contamination and would 
provide a unified standard to facilitate the mutual acceptance of test 
data by the relevant regulatory authorities. Because the draft 
guideline would apply to final product and master seed/cell testing in 
veterinary vaccines regulated by the APHIS under the Virus-Serum-Toxin 
Act (VSTA), we are requesting comments on its provisions so that we may 
include any relevant public input on the draft in the Agency's comments 
to the VICH Steering Committee.
    In accordance with the VICH process, once a final draft of the 
document has been approved, the guideline will be recommended for 
adoption by the regulatory bodies of the European Union, Japan, and the 
United States. As with all VICH documents, each final guideline will 
not create or confer any rights for or on any person and will not 
operate to bind APHIS or the public. Further, the VICH guidelines 
specifically provide for the use of alternative approaches if those 
approaches satisfy applicable regulatory requirements.
    Ultimately, APHIS intends to consider the VICH Steering Committee's 
final guideline for use by U.S. veterinary biologics licensees, 
permittees, and applicants. In addition, we may consider using the 
final guideline as the basis for proposed amendments to the regulations 
in 9 CFR chapter I, subchapter E (Viruses, Serums, Toxins, and 
Analogous Products; Organisms and Vectors). Because we anticipate that 
applicable provisions of the final version of ``Testing for the 
Detection of Mycoplasma Contamination'' may be introduced into APHIS' 
veterinary biologics regulatory program in the future, we encourage 
your comments on the draft guideline.
    The draft guideline may be viewed on the Regulations.gov Web site 
or in our reading room (see ADDRESSES above for instructions for 
accessing Regulations.gov and information on the location and hours of 
the reading room). You may request copies of the draft guideline by 
calling or writing to the person listed under FOR FURTHER INFORMATION 
CONTACT.

    Authority: 21 U.S.C. 151 et seq.

    Done in Washington, DC, this 9th day of April 2012.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2012-8908 Filed 4-12-12; 8:45 am]
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