[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32877-32878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15087]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0341]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; New Animal Drugs for 
Investigational Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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.

DATES: Fax written comments on the collection of information by August 
15, 2018.

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 emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0117. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

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.

New Animal Drugs for Investigational Use

OMB Control Number 0910-0117--Extension

    FDA has the authority under the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) to approve new animal drugs. A new animal drug 
application (NADA) cannot be approved until, among other things, the 
new animal drug has been demonstrated to be safe and effective for its 
intended use(s). In order to properly test a new animal drug for an 
intended use, appropriate scientific investigations must be conducted. 
Under specific circumstances, section 512(j) of the FD&C Act (21 U.S.C. 
360b(j)) permits the use of an investigational new animal drug to 
generate data to support an NADA approval. Section 512(j) of the FD&C 
Act authorizes us to issue regulations relating to the investigational 
use of new animal drugs.
    Our regulations in 21 CFR part 511 set forth the conditions for 
investigational use of new animal drugs and require reporting and 
recordkeeping. The information collected is necessary to protect the 
public health. We use the information to determine that investigational 
animal drugs are distributed only to qualified investigators, adequate 
drug accountability records are maintained, and edible food products 
from treated food-producing animals are safe for human consumption. We 
also use the information collected to monitor the validity of the 
studies submitted to us to support new animal drug approval.
    Reporting: Our regulations require that certain information be 
submitted to us in a ``Notice of Claimed Investigational Exemption for 
a New Animal Drug'' (NCIE) to qualify for the exemption and to control 
shipment of the new animal drug and prevent potential abuse. The NCIE 
must contain, among other things, the following specific information: 
(1) Identity of the new animal drug, (2) labeling, (3) statement of 
compliance of any nonclinical laboratory studies with good laboratory 
practices, (4) name and address of each clinical investigator, (5) the 
approximate number of animals to be treated or amount of new animal 
drug(s) to be shipped, and (6) information regarding the use of edible 
tissues from investigational animals (Sec.  511.1(b)(4) (21 CFR 
511.1(b)(4)). If the new animal drug is to be used in food-producing 
animals, e.g., cattle, swine, chickens, fish, etc., certain data must 
be submitted to us to obtain authorization for the use of edible food 
products from treated food-producing animals (Sec.  511.1(b)(5)). We 
require sponsors upon request to submit information with respect to the 
investigation to determine whether there are grounds for terminating 
the exemption (Sec.  511.1(b)(6)). We require sponsors to report 
findings that may suggest significant hazards pertinent to the safety 
of the new animal drug (Sec.  511.1(b)(8)(ii)). We also require 
reporting by importers of investigational new animal drugs for clinical 
investigational use in animals (Sec.  511.1(b)(9)). The information 
provided by the sponsor in the NCIE is needed to ensure that the 
proposed investigational use of the new animal drug is safe and that 
any edible food will not be distributed without proper authorization 
from FDA. Information contained in an NCIE submission is monitored 
under our Bio-Research Monitoring Program. This program permits us to 
monitor the validity of the studies and to ensure the proper use of the 
drugs is maintained by the investigators.
    Recordkeeping: If the new animal drug is only for tests in vitro or 
in laboratory research animals, the person distributing the new animal 
drug must maintain records showing the name and post office address of 
the expert or expert organization to whom it is shipped and the date, 
quantity, and batch or code mark of each shipment and delivery for a 
period of 2 years after such shipment or delivery (Sec.  511.1(a)(3) 
and (b)(3)). We require complete records of the investigation, 
including records of the receipt and disposition of each shipment or 
delivery of the investigational new animal drug (Sec.  511.1(b)(7)). We 
also require records of all reports received by a sponsor from 
investigators to be retained for 2 years after the termination of an 
investigational exemption or approval of a new animal drug application 
(Sec.  511.1(b)(8)(i)).
    Description of Respondents: Respondents to this collection of 
information are persons who use new animal drugs for investigational 
purposes. Investigational new animal drugs are used primarily by drug 
industry firms, academic institutions, and the government. 
Investigators may include individuals from these entities, as well as 
research firms and members of the medical professions.
    In the Federal Register of February 22, 2018 (83 FR 7735), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 32878]]



                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
     21 CFR section/activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
511.1(b)(4); submission of NCIE.             104           15.38           1,600               1           1,600
511.1(b)(5); submission of data              104            0.30              31               8             248
 to obtain authorization for the
 use of edible food products....
511.1(b)(6); submission of any               104            0.02               2               1               2
 additional information upon
 request of FDA.................
511.1(b)(8)(ii); reporting of                104            0.14              15               2              30
 findings that may suggest
 significant hazards pertinent
 to the safety of the new animal
 drug...........................
511.1(b)(9); reporting by                    104            0.14              15               8             120
 importers of investigational
 new animal drugs for clinical
 investigational use in animals.
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............           1,663  ..............           2,000
----------------------------------------------------------------------------------------------------------------
\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 section/activity         Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
511.1(a)(3); maintain records                104             2.5             260               1             260
 showing the name and post
 office address of the expert or
 expert organization to whom the
 new animal drug is shipped and
 the date, quantity, and batch
 or code mark of each shipment
 and delivery for a period of 2
 years after such shipment or
 delivery.......................
511.1(b)(3); maintain records                104           15.38           1,600               1           1,600
 showing the name and post
 office address of the expert or
 expert organization to whom the
 new animal drug or feed
 containing same is shipped and
 the date, quantity, and batch
 or code mark of each shipment
 and delivery for a period of 2
 years after such shipment or
 delivery.......................
511.1(b)(7); maintain records of             104           15.38           1,600             3.5           5,600
 the investigation, including
 records of the receipt and
 disposition of each shipment or
 delivery of the investigational
 new animal drug................
511.1(b)(8)(i); maintain records             104           15.38           1,600             3.5           5,600
 of all reports received by a
 sponsor from investigators.....
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............           5,060  ..............          13,060
----------------------------------------------------------------------------------------------------------------
\1.\There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimate of the time required for reporting requirements, 
record preparation, and maintenance for this collection of information 
is based on our informal communication with industry. Based on the 
number of sponsors subject to animal drug user fees, we estimate that 
there are 104 respondents. We use this estimate consistently throughout 
the table and calculate the ``number of responses per respondent'' by 
dividing the total annual responses by number of respondents. 
Additional information needed to make a final calculation of the total 
burden hours (i.e., the number of respondents, the number of 
recordkeepers, the number of NCIEs received, etc.) is derived from our 
records. The burden for this information collection has changed since 
the last OMB approval. We estimate an overall increase in burden that 
we attribute to an increase in the number of annual responses and 
records.

    Dated: July 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15087 Filed 7-13-18; 8:45 am]
 BILLING CODE 4164-01-P


