[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Notices]
[Pages 66280-66282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27812]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4428]
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 either electronic or written comments on the collection
of information by February 25, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 25, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets
[[Page 66281]]
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2018-N-4428 for ``Medicated Feed Mill License Application.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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 515--OMB Control
Number 0910-0337--Extension
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 (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 require the submission of a supplemental medicated feed mill
license application for a change in facility ownership or a change in
facility address (Sec. 515.11(b)). If a licensed facility is no longer
manufacturing medicated animal feed under Sec. 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 Sec.
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 Total hours
respondents respondent responses per response
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Medicated Feed Mill License 14 1 14 0.25 (15 4
Application using Form FDA minutes).
3448 (515.10(b)).
Supplemental Feed Mill License 54 1 54 0.25 (15 14
Application using Form FDA minutes).
3448 (515.11(b)).
Voluntary Revocation of 29 1 29 0.25 (15 7
Medicated Feed Mill License minutes).
(515.23).
[[Page 66282]]
Filing a Request for a Hearing 1 1 1 4............... 4
on Medicated 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 Average burden
21 CFR section and activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Maintenance of Records for 837 1 837 0.03 (2 minutes) 25
Approved Labeling 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 14
medicated feed mill license applications, 54 supplemental applications,
29 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
Sec. 515.30(c) takes approximately 4 hours, as shown in table 1, row
4. In table 2, we estimate that 837 licensees will keep the records
required by 21 CFR 510.305 expending a total of 25 hours annually.
Our estimated burden for the information collection reflects an
overall decrease of 2 hours and a corresponding decrease of 56
responses/records. We attribute this adjustment to a net decrease in
the number of submissions we received over the last few years.
Dated: December 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27812 Filed 12-21-18; 8:45 am]
BILLING CODE 4164-01-P