Reporting Associated with New Animal Drug Applications and Veterinary Master Files

OMB 0910-0032

OMB 0910-0032

Any person may file a new animal drug application (NADA) seeking FDA approval to legally market a new animal drug. The application must include safety and effectiveness data, proposed labeling, product manufacturing information, and where necessary, complete information on food safety (including microbial food safety) and any methods used to determine residues of drug in edible tissue from food producing animals. FDA Guidance #152 outlines a risk assessment approach for evaluating the microbial food safety of antimicrobial new animal drugs. We request that applicants utilize Form FDA 356V, as appropriate, to ensure efficient and accurate processing of information to support new animal drug approval. Respondents may choose to use veterinary master files to provide and organize confidential detailed information to the Agency. Veterinary master files can be used as repositories for information that can be referenced in multiple submissions to the Agency, thus minimizing paperwork burden.

The latest form for Reporting Associated with New Animal Drug Applications and Veterinary Master Files expires 2022-07-31 and can be found here.

All Historical Document Collections
Approved without change
Extension without change of a currently approved collection 2019-06-26
Approved without change
Extension without change of a currently approved collection 2016-06-03
Approved without change
Extension without change of a currently approved collection 2013-05-15
Approved without change
Extension without change of a currently approved collection 2011-04-28
Approved without change
Revision of a currently approved collection 2008-03-04
Approved without change
Extension without change of a currently approved collection 2004-11-01
Approved without change
Extension without change of a currently approved collection 2001-04-26
Approved without change
Reinstatement with change of a previously approved collection 1998-05-29
Approved without change
Reinstatement with change of a previously approved collection 1994-01-07
Approved with change
No material or nonsubstantive change to a currently approved collection 1993-03-04
Approved without change
Revision of a currently approved collection 1992-10-19
Approved without change
Reinstatement with change of a previously approved collection 1991-06-17
Approved with change
No material or nonsubstantive change to a currently approved collection 1989-05-03
Approved without change
Reinstatement with change of a previously approved collection 1988-01-04
Approved with change
No material or nonsubstantive change to a currently approved collection 1986-11-20
Approved without change
Revision of a currently approved collection 1986-03-19
Approved without change
Revision of a currently approved collection 1985-10-30
Approved without change
Reinstatement with change of a previously approved collection 1985-07-08
Approved with change
No material or nonsubstantive change to a currently approved collection 1979-11-20
Approved without change
Extension without change of a currently approved collection 1979-04-02
Approved with change
No material or nonsubstantive change to a currently approved collection 1977-11-18
Approved without change
Revision of a currently approved collection 1977-08-31

© 2021 OMB.report | Privacy Policy