81 FR 12509 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 46 (March 9, 2016)

The Food and Drug Administration (FDA, we) 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 collection of information associated with Medicated Feed Mill License Applications.

[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12509-12511]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05214]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0511]


Agency Information Collection Activities; Proposed Collection; 
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, we) 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 collection of information 
associated with Medicated Feed Mill License Applications.

DATES: Submit either electronic or written comments on the collection 
of information by May 9, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

[[Page 12510]]

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2009-N-0511 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Medicated Feed Mill License 
Application.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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 License Application--21 CFR Part 5157--OMB Control 
Number 0910-0337--Revision

    Feed manufacturers that seek to manufacture feed using Category II, 
Type A medicated articles or manufacture certain liquid and free-choice 
feed, using Category I, Type A medicated articles that must follow 
proprietary formulas or specifications are required to obtain a 
facility license under section 512 of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360b). Our regulations in part 
515 (21 CFR part 515) establish the procedures associated with applying 
for a facility license. We require that a manufacturer seeking a 
facility license submit a completed medicated feed mill license 
application using Form FDA 3448 (21 CFR 515.10(b)). We use the 
information submitted to establish that the applicant has made the 
certifications required by section 512 of the FD&C Act, to register the 
mill, and to schedule a pre-approval inspection. We have made minor 
editorial revisions to Form FDA 3448, including the addition of a 
dedicated field for the submitter's email address in the contact 
information section. We estimate that the revisions will not change the 
amount of time necessary to complete the form.
    We require the submission of a supplemental medicated feed mill 
license application for a change in facility ownership or a change in 
facility address (21 CFR 515.11(b)). If a licensed facility is no 
longer manufacturing medicated animal feed under 21 CFR 515.23, a 
manufacturer may request voluntary revocation of a medicated feed mill 
license. An applicant also has the right to file a request for hearing 
under 21 CFR 515.30(c) to give reasons why a medicated feed mill 
license should not be refused or revoked.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                    Number of
          21 CFR section and activity               Number of     responses per   Total annual         Average burden per response          Total hours
                                                   respondents     respondent       responses
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Medicated Feed Mill License Application Using                20               1              20  0.25 (15 minutes)......................               5
 Form FDA 3448 (515.10(b)).

[[Page 12511]]

 
Supplemental Feed Mill License Application                   40               1              40  0.25 (15 minutes)......................              10
 Using Form FDA 3448 (515.11(b)).
Voluntary Revocation of Medicated Feed Mill                  40               1              40  0.25 (15 minutes)......................              10
 License (515.23).
Filing a Request for a Hearing on Medicated                   1               1               1  4......................................               4
 Feed Mill License (515.30(c)).
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    Total......................................  ..............  ..............  ..............  .......................................              29
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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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                                                                    Number of
          21 CFR section and activity               Number of      records per    Total annual      Average  burden per  recordkeeping      Total hours
                                                  recordkeepers   recordkeeper       records
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Maintenance of Records for Approved Labeling                890               1             890  0.03 (2 minutes).......................            26.7
 for Each ``Type B'' and ``Type C'' Feed
 (510.305).
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    These estimates are based on our experience with medicated feed 
mill license applications. We estimate that we will receive 20 
medicated feed mill license applications, 40 supplemental applications, 
40 requests for voluntary revocation, and that these submissions will 
take approximately 15 minutes per response, as shown in table 1, rows 1 
through 3. We estimate that preparing a request for a hearing under 21 
CFR 515.30(c) takes approximately 4 hours, as shown in table 1, row 4. 
In table 2, we estimate that 890 licensees will keep the records 
required by 21 CFR 510.305 expending a total of 26.7 hours annually.

    Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05214 Filed 3-8-16; 8:45 am]
 BILLING CODE 4164-01-P