[Federal Register: November 14, 2006 (Volume 71, Number 219)]
[Notices]
[Page 66335]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14no06-45]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0329]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medicated Feed Mill
License Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: 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.
DATES: Fax written comments on the collection of information by
December 14, 2006
ADDRESSES: 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: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medicated Feed Mill Licensing Application--21 CFR Part 515 (OMB Control
No. 0910-0337)--Extension
The Animal Drug Availability Act (ADAA) of October 9, 1996, amended
section 512 of the Federal Food, Drug, and Cosmetic 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. Implementing regulations are at part 515
(21 CFR part 515).
In the Federal Register of August 25, 2006 (71 FR 50433), FDA
solicited comments on the information collection provisions of this
proposed collection. In response to that request, FDA received no
comments.
Description of Respondents: Medicated feed manufacturers.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency per Total Annual Hours per
21 CFR Section Respondents Response Responses Response Total Hours
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515.10(b) 7 1 7 0.25 1.75
515.11(b) 100 1 100 0.25 25
515.23 25 1 25 0.25 6.25
515.30(c) 0.15 1 0.15 24 3.6
Total ................. .................... .................... ................. 36.6
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency Hours per
21 CFR Section Recordkeepers per Recordkeeping Total Annual Records Recordkeeper Total Hours
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510.305 1,070 1 1,070 0.03 32.10
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated annual reporting burden on industry is 36.6 hours as
shown in table 1 of this document. Industry estimates it takes about 1/
4 hour to submit the application. We estimate 132 original and
supplemental applications, and voluntary revocations for a total of 33
hours (132 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 36 hours for maintaining
and retrieving labels as required by 21 CFR 510.305. We estimated .03
hours for each of approximately 1,070 licensees. Thus, the total burden
for recordkeeping requirements is 32.10 hours (1,070 x 0.03).
Dated: November 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19152 Filed 11-13-06; 8:45 am]
BILLING CODE 4160-01-S