[Federal Register Volume 65, Number 144 (Wednesday, July 26, 2000)]
[Notices]
[Pages 45987-45988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18943]


=======================================================================
-----------------------------------------------------------------------

 DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1395]


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

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

DATES: Submit written comments on the collection of information by 
September 25, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (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 Information 
Resources Management (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: (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 License 21 CFR Part 515--(OMB Control Number 
0910-0337)--Extension

    In the Federal Register of November 19, 1999 (64 FR 63195), FDA 
published a final rule implementing the feed mill licensing provisions 
of the Animal Drug Availability Act of 1966 (Public Law 104-250). The 
rule added part 515 (21 CFR part 515) to provide the requirements for 
medicated feed mill licensing.

[[Page 45988]]

    The rule set forth the information to be included in a medicated 
feed mill license application and subsequent supplemental applications. 
Also, it set forth criteria for the approval and nonapproval of a 
medicated feed mill license application and the criteria for the 
revocation and/or suspension of a license. More specifically, 
Sec. 515.10(b) specifies requirements for submitting a completed 
medicated feed mill license application, using Form FDA 3448. Section 
515.11(b) specifies requirements for supplemental medicated feed 
applications for a change in ownership and/or change in mailing address 
for the facility cite, using Form FDA 3448. Section 515.23 sets forth 
written requirements for voluntary revocation of a medicated feed mill 
license by a sponsor on the grounds that the facility no longer 
manufacture any animal feed. Section 515.30(c) details requirements for 
filing a request for a hearing by a sponsor to give reasons why a 
medicated feed mill license application should not be refused or 
revoked and Sec. 510.305(b) (21 CFR 510.305(b)) requires maintenance of 
approved labeling for each Type B and/or Type C feed being manufactured 
on the premises of the manufacturing establishment or the facility 
where the feed labels are generated.
    Respondents to this collection of information are individuals or 
firms that manufacture medicated animal feed.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
----------------------------------------------------------------------------------------------------------------
515.10(b)                             100               1             100               0.25           25
515.11(b)                              25               1              25               0.25            6.25
515.23                                 50               1              50               0.25           12.25
515.30(c)                               0.15            1               0.15           24               3.6
Total                                                                                                  47.10
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
----------------------------------------------------------------------------------------------------------------
510.305(b)                            100               1             100                .25          25
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimate for the number of respondents is derived from agency 
data, i.e. the number of medicated feed manufacturers entering the 
market each year, change in ownership or address, requests for 
voluntary revocation of a medicated feed mill license, revocation and/
or suspension of a license. The estimate of the time required for the 
reporting and recordkeeping requirements is based on the agency 
communication with industry.

    Dated: July 21, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-18943 Filed 7-25-00; 8:45 am]
BILLING CODE 4160-01-F