81 FR 93689 - Agency Information Collection Activities; Proposed Collection; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 245 (December 21, 2016)

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 information collection provisions of FDA regulations related to public index listing of legally marketed unapproved new animal drugs for minor species of animals.

[Federal Register Volume 81, Number 245 (Wednesday, December 21, 2016)]
[Notices]
[Pages 93689-93691]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-30676]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0597]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Index of Legally Marketed Unapproved New Animal Drugs 
for Minor Species

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 information collection 
provisions of FDA regulations related to public index listing of 
legally marketed unapproved new animal drugs for minor species of 
animals.

DATES: Submit either electronic or written comments on the collection 
of information by February 21, 2017.

ADDRESSES: You may submit comments as follows:

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

[[Page 93690]]

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): 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-2010-N-0597 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Index of Legally Marketed 
Unapproved New Animal Drugs for Minor Species.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://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 https://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 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 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, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [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.

Index of Legally Marketed Unapproved New Animal Drugs for Minor 
Species--21 CFR Part 516

OMB Control Number 0910-0620--Extension

    The Minor Use and Minor Species Animal Health Act of 2004 (MUMS 
Act) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to 
authorize FDA to establish new regulatory procedures intended to make 
more medications legally available to veterinarians and animal owners 
for the treatment of minor animal species (species other than cattle, 
horses, swine, chickens, turkeys, dogs, and cats), as well as uncommon 
diseases in major animal species.
    Section 572 of the MUMS Act provided for a public index listing of 
legally marketed unapproved new animal drugs for minor species. FDA 
regulations in part 516 (21 CFR part 516) specify, among other things, 
the criteria and procedures for requesting eligibility for indexing and 
for requesting addition to the index as well as the annual reporting 
requirements for index holders.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 93691]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
           21 CFR part               Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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516.119.........................               2               1               2               1               2
516.121.........................              30               2              60               4             240
516.123.........................               3               1               3               8              24
516.125.........................               2               3               6              20             120
516.129.........................              30               2              60              20           1,200
516.141.........................              20               1              20              16             320
516.143.........................              20               1              20             120           2,400
516.145.........................              20               1              20              20             400
516.161.........................               1               1               1               4               4
516.163.........................               1               1               1               2               2
516.165.........................              10               2              20               8             160
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    Total.......................  ..............  ..............  ..............  ..............           4,872
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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 part              Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
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516.141.......................              30               2              60  0.5 (30 minutes)              30
516.165.......................              10               2              20  1...............              20
    Total.....................  ..............  ..............  ..............  ................              50
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: December 13, 2016.
Leslie Kux,
Associate Commission for Policy.
[FR Doc. 2016-30676 Filed 12-20-16; 8:45 am]
 BILLING CODE 4164-01-P