Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by February 22, 2010.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or e-mailed to
Denver Presley Jr., Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3793.
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
The Animal Drug Availability Act (ADAA) of October 9, 1996, amended section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b) to replace the system for the approval of specific medicated feed with a general licensing system for feed mills. Before passage of the ADAA, medicated feed manufacturers were required to obtain approval of Medicated Feed Applications (MFAs), in order to manufacture certain types of medicated feeds. An individual approved MFA was required for each and every applicable medicated feed. The ADAA streamlined the paperwork process for gaining approval to manufacture medicated feeds by replacing the MFA system with a facility license for each medicated feed manufacturing facility.
In the
FDA estimates the burden of this collection of information as follows:
The estimated annual reporting burden on industry is 37.35 hours as shown in table 1 of this document. Industry estimates it takes about 1/4 hour to submit the application. We estimate 135 original and supplemental applications, and voluntary revocations for a total of 33.75 hours (135 submissions x 1/4 hour). An additional 3.6 hours is added for the rare notice of opportunity for a hearing to not approve or revoke an application. Finally, we estimate 30 hours for maintaining and retrieving labels as required by 21 CFR 510.305 and shown in table 2 of this document. We estimated .03 hours for each of approximately 1,000 licensees. Thus, the total annual burden for reporting and recordkeeping requirements is estimated be 67.35 hours.