[Federal Register Volume 71, Number 165 (Friday, August 25, 2006)]
[Notices]
[Pages 50433-50434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14076]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0329]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medicated Feed Mill License Application--Extension

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: 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 of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the medicated feed mill 
licensing system.

DATES: Submit written or electronic comments on the collection of 
information by October 24, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Medicated Feed Mill Licensing Application--21 CFR Part 515 (OMB Control 
Number 0910-0337)--Extension

    The Animal Drug Availability Act of 1996 (ADAA), 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 21 CFR 
part 515.
    Respondents are expected to be medicated feed manufacturers.
    FDA estimates the burden for this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          No. of          Annual Frequency       Total Annual          Hours per
                  21 CFR Section                        Respondents         per Response           Responses           Response           Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 Burden Hours                                                                                                                                 36.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 50434]]


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
510.305                                                             1,070                     1              1,070               0.03              32.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 
0.25 hours to submit the application. We estimate 132 original and 
supplemental applications and voluntary revocations for a total of 33 
hours (132 submissions x 0.25 hours). An additional 3.6 hours are 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 licensees x 0.03 
hours).

    Dated: August 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14076 Filed 8-24-06; 8:45 am]
BILLING CODE 4160-01-S