Document ID: FDA-2010-N-0597-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
Posted Date: 2011-02-25T05:00Z

[Federal Register: February 25, 2011 (Volume 76, Number 38)]
[Notices]               
[Page 10605-10607]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe11-72]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

[[Page 10606]]

DATES: Fax written comments on the collection of information by March 
28, 2011.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0620. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7651, Juanmanuel.vilela@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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.
    The MUMS Act created three new sections in the FD&C Act (sections 
571, 572, and 573 (21 U.S.C. 360ccc, 360ccc-1, and 360ccc-2)). The 
final rule (72 FR 69108, December 6, 2007) (the December 2007 final 
rule) implements section 572 of the FD&C Act that provides for an index 
of legally marketed unapproved new animal drugs for minor species. 
Participation in any part of the MUMS program is optional so the 
associated paperwork only applies to those who choose to participate. 
The December 2007 final rule specifies, 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.
    Under the new subpart C of part 516 (21 CFR part 516), Sec.  
516.119 provides requirements for naming a permanent-resident U.S. 
agent by foreign drug companies, and Sec.  516.121 provides for 
informational meetings with FDA. Section 516.123 provides requirements 
for requesting informal conferences regarding Agency administrative 
actions and Sec.  516.125 provides for investigational use of new 
animal drugs intended for indexing. Provisions for requesting a 
determination of eligibility for indexing can be found under Sec.  
516.129 and provisions for subsequent requests for addition to the 
index can be found under Sec.  516.145. A description of the written 
report required in Sec.  516.145 can be found under Sec.  516.143. 
Under Sec.  516.141 are provisions for drug companies to nominate a 
qualified expert panel as well as the panel's recordkeeping 
requirements. Section 516.141 also calls for the submission of a 
written conflict of interest statement to FDA by each proposed panel 
member. Index holders are able to modify their index listing under 
Sec.  516.161 or change drug ownership under Sec.  516.163. 
Requirements for records and reports are under Sec.  516.165.
    In the Federal Register of December 3, 2010 (75 FR 75481), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comments.
    Description of Respondents: Pharmaceutical companies that sponsor 
new animal drugs.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
         21 CFR section               No. of       frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       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
    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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                                                      Annual
         21 CFR section               No. of       frequency per   Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeper
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516.141.........................              30               2              60             0.5              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.

[[Page 10607]]

    Dated: February 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4219 Filed 2-24-11; 8:45 am]
BILLING CODE 4160-01-P