Source: https://www.federalregister.gov/articles/2012/12/21/2012-30738/agency-information-collection-activities-proposed-collection-comment-request-medicated-feed-mill
Timestamp: 2016-07-24 12:49:05
Document Index: 592519291

Matched Legal Cases: ['art 515', 'art 515', 'art 515', '§ 515', '§ 515', '§ 515', '§ 515', '§ 510']

Federal Register | Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application; Extension
Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application; Extension
Dates: Submit written or electronic comments on the collection of information by February 19, 2013.
Comments Close: 02/19/2013
77 FR 75635
-75636 (2 pages)
Docket No.FDA-2012-N-1181
Document Number: 2012-30738
Shorter URL: https://federalregister.gov/a/2012-30738 Regulations.gov Docket Info
FDA-2012-N-1181
Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application; Extension - CLOSED
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension and to allow 60 days for public comment in response to the notice. This notice solicits comments on the medicated feed mill licensing system.
Medicated Feed Mill Licensing Application—21 CFR Part 515 (OMB Control Number 0910-0337)—Extension
Submit written or electronic comments on the collection of information by February 19, 2013.
Submit electronic comments on the collection of information to: http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.
Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PIFO-410B, Rockville, MD 20850, 301-796-3794.
Medicated Feed Mill Licensing Application—21 CFR Part 515 (OMB Control Number 0910-0337)—Extension Back to Top
The Animal Drug Availability Act (ADAA) of October 9, 1996, amended section 512 of the Federal Food, Drug, and Cosmetic Act 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. Implementing regulations are at 21 CFR part 515.
21 CFR section and activity
1There are no capital costs or maintenance costs associated with this information collection.
Medicated Feed Mill License Application Using Form FDA 3448 (§ 515.10(b))
Supplemental Feed Mill License Application Using Form FDA 3448 (§ 515.11(b))
Voluntary Revocation of Medicated Feed Mill License (§ 515.23)
Filing a Request for a Hearing on Medicated Feed Mill License (§ 515.30(c))
Maintenance of Records for Approved Labeling for Each “Type B” and “Type C” Labeling (§ 510.305)
Estimated annual reporting burden on industry is 29 hours as shown in table 1. Industry estimates it takes about 15 minutes (.25) to submit the application. We estimate 100 original and supplemental applications, and voluntary revocations for a total of 25 hours (100 submissions × .25 (15 minutes)). An additional 4 hours is added for the rare notice of opportunity for a hearing to not approve or revoke an application. Finally, we estimate 28.5 hours for maintaining and retrieving labels as required by 21 CFR 510.305. We estimated .03 hours for each of approximately 950 licensees. Total burden for reporting and recordkeeping would be 57.5 hours.
[FR Doc. 2012-30738 Filed 12-20-12; 8:45 am]