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)

Page Range		93689-93691
FR Document		2016-30676

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 Issue 245 (Wednesday, December 21, 2016)

[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.

-----------------------------------------------------------------------

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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
           21 CFR part               Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
          21 CFR part              Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
516.141.......................              30               2              60  0.5 (30 minutes)              30
516.165.......................              10               2              20  1...............              20
    Total.....................  ..............  ..............  ..............  ................              50
----------------------------------------------------------------------------------------------------------------
\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

Federal Register / Vol. 81, No. 245 / Wednesday, December 21, 2016 / Notices 93689

and National Aeronautics and Space FOR FURTHER INFORMATION CONTACT: Mr. Regulatory Secretariat Division (MVCB),
Administration (NASA). Michael O. Jackson, Procurement 1800 F Street NW., Washington, DC
ACTION: Notice of request for comments Analyst, Contract Policy Branch, GSA, 20405, telephone 202–501–4755. Please
regarding an extension to an existing 202–208–4949 or email cite OMB Control Number 9000–0034,
OMB clearance. michaelo.jackson@gsa.gov. Examination of Records by Comptroller
SUPPLEMENTARY INFORMATION: General and Contract Audit, in all
SUMMARY: Under the provisions of the correspondence.
Paperwork Reduction Act, the A. Purpose
Dated: December 16, 2016.
Regulatory Secretariat Division will be The objective of this information
Lorin S. Curit,
submitting to the Office of Management collection, for the examination of
and Budget (OMB) a request to review Director, Federal Acquisition Policy, Office
records by Comptroller General and
of Government-wide Acquisition Policy,
and approve an extension of a contract audit, is to require contractors Office of Acquisition Policy, Office of
previously approved information to maintain certain records and to Government-wide Policy.
collection requirement concerning the ensure the Comptroller General and/or [FR Doc. 2016–30700 Filed 12–20–16; 8:45 am]
examination of records by comptroller agency have access to, and the right to,
BILLING CODE 6820–EP–P
general and contract audit. A notice was examine and audit records, which
published in the Federal Register at 81 includes: Books, documents, accounting
FR 62502 on September 9, 2016. No procedures and practices, and other DEPARTMENT OF HEALTH AND
comments were received. data, regardless of type and regardless of HUMAN SERVICES
DATES: Submit comments on or before whether such items are in written form,
January 20, 2017. in the form of computer data, or in any Food and Drug Administration
ADDRESSES: Submit comments regarding other form, for a period of three years
after final payment. This information is [Docket No. FDA–2010–N–0597]
this burden estimate or any other aspect
of this collection of information, necessary for examination and audit of Agency Information Collection
including suggestions for reducing this contract surveillance, verification of Activities; Proposed Collection;
burden to: Office of Information and contract pricing, and to provide Comment Request; Index of Legally
Regulatory Affairs of OMB, Attention: reimbursement of contractor costs, Marketed Unapproved New Animal
Desk Officer for GSA, Room 10236, where applicable. The records retention Drugs for Minor Species
NEOB, Washington, DC 20503. period is required by the statutory
Additionally submit a copy to GSA by authorities at 10 U.S.C. 2313, 41 U.S.C. AGENCY: Food and Drug Administration,
any of the following methods: 254, and 10 U.S.C. 2306, and are HHS.
• Regulations.gov: http:// implemented through the following ACTION: Notice.
www.regulations.gov. Submit comments clauses: Audit and Records-Negotiation
via the Federal eRulemaking portal by clause, 52.215–2; Contract Terms and SUMMARY: The Food and Drug
searching for OMB Control No. 9000– Conditions Required to Implement Administration (FDA) is announcing an
0034. Select the link ‘‘Comment Now’’ Statutes or Executive Orders- opportunity for public comment on the
that corresponds with ‘‘Information Commercial Items clause, 52.212–5; and proposed collection of certain
Collection 9000–0034, Examination of Audit and Records-Sealed Bidding information by the Agency. Under the
Records by Comptroller General and clause, 52.214–26. This information Paperwork Reduction Act of 1995 (the
Contract Audit.’’ Follow the instructions collection does not require contractors PRA), Federal Agencies are required to
provided on the screen. Please include to create or maintain any records that publish notice in the Federal Register
your name, company name (if any), and the contractor does not normally concerning each proposed collection of
‘‘Information Collection 9000–0034, maintain in its usual course of business. information, including each proposed
Examination of Records by Comptroller extension of an existing collection of
B. Annual Reporting Burden
General and Contract Audit’’ on your information, and to allow 60 days for
Respondents: 20,646. public comment in response to the
attached document. Responses per Respondent: 9.
• Mail: General Services notice. This notice solicits comments on
Total Number of Responses: 185,814. the information collection provisions of
Administration, Regulatory Secretariat Hours per Response: 1.0.
Division (MVCB), 1800 F Street NW., FDA regulations related to public index
Total Burden Hours: 185,814.
Washington, DC 20405. ATTN: Ms. listing of legally marketed unapproved
Flowers/IC 9000–0034, Examination of C. Public Comments new animal drugs for minor species of
Records by Comptroller General and Public comments are particularly animals.
Contract Audit. invited on: Whether this collection of DATES: Submit either electronic or
Instructions: Please submit comments information is necessary for the proper written comments on the collection of
only and cite Information Collection performance of functions of the Federal information by February 21, 2017.
9000–0034, in all correspondence Acquisition Regulation (FAR), and ADDRESSES: You may submit comments
related to this collection. Comments whether it will have practical utility; as follows:
received generally will be posted whether our estimate of the public
without change to http:// Electronic Submissions
burden of this collection of information
www.regulations.gov, including any is accurate, and based on valid Submit electronic comments in the
asabaliauskas on DSK3SPTVN1PROD with NOTICES

personal and/or business confidential assumptions and methodology and ways following way:
information provided. To confirm to enhance the quality, utility, and • Federal eRulemaking Portal:
receipt of your comment(s), please clarity of the information to be https://www.regulations.gov. Follow the
check www.regulations.gov, collected. instructions for submitting comments.
approximately two to three days after Obtaining Copies of Proposals: Comments submitted electronically,
submission to verify posting (except Requesters may obtain a copy of the including attachments, to https://
allow 30 days for posting of comments information collection documents from www.regulations.gov will be posted to
submitted by mail). the General Services Administration, the docket unchanged. Because your

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Federal Register / Vol. 81, No. 245 / Wednesday, December 21, 2016 / Notices 93691

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR part responses per burden per Total hours
respondents responses
respondent response

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
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
Number of Total annual
21 CFR part records per Average burden per recordkeeping Total hours
recordkeepers records
recordkeeper

516.141 ............................................. 30 2 60 0.5 (30 minutes) ............................... 30
516.165 ............................................. 10 2 20 1 ........................................................ 20
Total ........................................... ........................ ........................ ........................ ........................................................... 50
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: December 13, 2016. Agenda: To review and evaluate contract 9823, Bethesda, MD 20892–9823, (240) 669–
Leslie Kux, proposals. 5036, poeky@mail.nih.gov.
Associate Commission for Policy. Place: National Institutes of Health, 5601 (Catalogue of Federal Domestic Assistance
Fishers Lane, Rockville, MD 20892, Program Nos. 93.855, Allergy, Immunology,
[FR Doc. 2016–30676 Filed 12–20–16; 8:45 am] (Telephone Conference Call). and Transplantation Research; 93.856,
BILLING CODE 4164–01–P Contact Person: Kelly Y. Poe, Scientific Microbiology and Infectious Diseases
Review Program, Division of Extramural Research, National Institutes of Health, HHS)
Activities, Room 3F40B, National Institutes
DEPARTMENT OF HEALTH AND of Health, NIAID, 5601 Fishers Lane, MSC Dated: December 15, 2016.
HUMAN SERVICES 9823, Bethesda, MD 20892–9823, (240) 669– Natasha M. Copeland,
5036, poeky@mail.nih.gov. Program Analyst, Office of Federal Advisory
National Institutes of Health Name of Committee: National Institute of Committee Policy.
Allergy and Infectious Diseases Special [FR Doc. 2016–30691 Filed 12–20–16; 8:45 am]
National Institute of Allergy And Emphasis Panel; NIAID Peer Review Meeting. BILLING CODE 4140–01–P
Infectious Diseases; Notice of Closed Date: January 13, 2017.
Meetings Time: 3:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract DEPARTMENT OF HEALTH AND
Pursuant to section 10(d) of the proposals.
HUMAN SERVICES
Federal Advisory Committee Act, as Place: National Institutes of Health, 5601
amended (5 U.S.C. App.), notice is Fishers Lane, Rockville, MD 20892,
(Telephone Conference Call).
National Institutes of Health
hereby given of the following meetings.
Contact Person: Kelly Y. Poe, Scientific
The meetings will be closed to the National Institute of Mental Health;
Review Program, Division of Extramural
public in accordance with the Activities, Room 3F40B, National Institutes Notice of Closed Meeting
provisions set forth in sections of Health, NIAID, 5601 Fishers Lane, MSC
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 9823, Bethesda, MD 20892–9823, (240) 669–
Pursuant to section 10(d) of the
as amended. The contract proposals and 5036, poeky@mail.nih.gov. Federal Advisory Committee Act, as
the discussions could disclose Name of Committee: National Institute of
amended (5 U.S.C. App.), notice is
confidential trade secrets or commercial Allergy and Infectious Diseases Special hereby given of the following meeting.
property such as patentable material, Emphasis Panel; NIAID Peer Review Meeting. The meeting will be closed to the
and personal information concerning Date: January 27, 2017. public in accordance with the
Time: 11:00 a.m. to 4:00 p.m. provisions set forth in sections
asabaliauskas on DSK3SPTVN1PROD with NOTICES

individuals associated with the contract
proposals, the disclosure of which Agenda: To review and evaluate contract 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
proposals. as amended. The grant applications and
would constitute a clearly unwarranted
Place: National Institutes of Health, 5601
invasion of personal privacy. the discussions could disclose
Fishers Lane, Rockville, MD 20892,
Name of Committee: National Institute of (Telephone Conference Call). confidential trade secrets or commercial
Allergy and Infectious Diseases Special Contact Person: Kelly Y. Poe, Scientific property such as patentable material,
Emphasis Panel; NIAID Peer Review Meeting. Review Program, Division of Extramural and personal information concerning
Date: January 13, 2017. Activities, Room 3F40B, National Institutes individuals associated with the grant
Time: 11:00 a.m. to 3:00 p.m. of Health, NIAID, 5601 Fishers Lane, MSC applications, the disclosure of which

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Document Created: 2018-02-14 09:11:51
Document Modified: 2018-02-14 09:11:51

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by February 21, 2017.
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]
FR Citation		81 FR 93689

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 SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration