[Federal Register Volume 84, Number 122 (Tuesday, June 25, 2019)]
[Notices]
[Pages 29866-29867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13430]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0482]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Reporting Associated 
With New Animal Drug Applications and Veterinary Master Files

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 July 
25, 2019.

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 0910-0032. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[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.

Reporting Associated With New Animal Drug Applications (NADA) and 
Veterinary Master Files--21 CFR 514.1, 514.4, 514.5, 514.6, 514.8, 
514.11, and 558.5

OMB Control Number 0910-0032--Extension

    Under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 360b(b)(1)), any person may file a new animal 
drug application (NADA) seeking our approval to legally market a new 
animal drug. Section 512(b)(1) of the FD&C Act sets forth the 
information required to be submitted in a NADA. Sections 514.1, 514.4, 
514.6, 514.8, and 514.11 of our regulations (21 CFR 514.1, 514.4, 
514.6, 514.8, and 514.11) further specify the information that the NADA 
must contain. The application must include safety and effectiveness 
data, proposed labeling, product manufacturing information, and where 
necessary, complete information on food safety (including microbial 
food safety) and any methods used to determine residues of drug 
chemicals in edible tissue from food producing animals. FDA Guidance 
for Industry #152 outlines a risk assessment approach for evaluating 
the microbial food safety of antimicrobial new animal drugs. We request 
that applicants utilize Form FDA 356V, as appropriate, to ensure 
efficient and accurate processing of information to support new animal 
drug approval.
    Under section 512(b)(3) of the FD&C Act, any person intending to 
file a NADA or supplemental NADA or a request for an investigational 
exemption under section 512(j) of the FD&C Act is entitled to one or 
more conferences with us prior to making a submission. Section 514.5 of 
our regulations (21 CFR 514.5) describes the procedures for requesting, 
conducting, and documenting presubmission conferences. We have found 
that these meetings have increased the efficiency of the drug 
development and drug review processes. We encourage sponsors to submit 
data for review at the most appropriate and productive times in the 
drug development process. Rather than submitting all data for review as 
part of a complete application, we have found that the submission of 
data supporting discrete technical sections during the investigational 
phase of the new animal drug is the most appropriate and productive. 
This ``phased review'' of data submissions has created efficiencies for 
both us and the animal pharmaceutical industry.
    Additionally, we have found that various uses of veterinary master 
files have increased the efficiency of the drug development and drug 
review processes for both us and the animal pharmaceutical industry. A 
veterinary master file is a repository for submission to FDA's Center 
for Veterinary Medicine of confidential detailed information about 
facilities, processes, or articles used in the manufacturing, 
processing, packaging, and storing of one or more veterinary drugs. The 
benefits of veterinary master files include confidential exchange of 
information with FDA, a process for reporting information outside of a 
NADA or an investigational new animal drug (INAD) file, as well as an 
opportunity for increased communication with FDA during early stages of 
product development. Respondents may choose to use veterinary master 
files to provide and organize confidential detailed information to the 
Agency. A holder of a veterinary master file may also authorize other 
parties to reference information in the veterinary master file without 
disclosing information in the file to those parties. Veterinary master 
files can be used as repositories for information that can be 
referenced in multiple submissions to the Agency, thus minimizing 
paperwork burden. Veterinary master files are already used by the 
animal pharmaceutical industry in support of information being 
submitted for NADAs, abbreviated new animal drug applications (ANADAs), 
INAD files, and generic investigational new animal drug (JINAD) files. 
In previous information collection requests, we have included the time 
necessary to compile and submit such information to veterinary master 
files within the burden estimates provided for applications and amended 
applications (for NADAs and INAD files) and abbreviated applications 
and amended abbreviated applications (for ANADAs and JINAD files), 
respectively. We are now combining the time necessary to compile and 
submit such information to veterinary master files within the burden 
estimates provided in this collection of information.
    We are also developing new approaches to permit more complex uses 
of veterinary master files to facilitate the development of animal drug 
products. We expect respondents will want to use veterinary master 
files to submit information to us for review and consultation during 
all phases of animal drug product development (including product 
development that precedes the establishment of an INAD file or the 
submission of a NADA). This information could include information about 
processes, facilities, or articles used in the manufacturing, 
processing,

[[Page 29867]]

packaging, and storing of veterinary drugs and drug substances. 
Information submitted to FDA through a veterinary master file could 
also include drug characterization, methods, protocols, or other 
relevant information. In this request for OMB review, we seek approval 
of an increased use of veterinary master files by respondents to submit 
additional information to us for review and consultation during all 
phases of animal drug product development (including product 
development that precedes the establishment of an INAD file or the 
submission of a NADA). To account for an expected increase in reporting 
burden hours associated with the increased use of veterinary master 
files by respondents, we are separately estimating in table 1, row 10, 
the burden of the use of veterinary master files during all phases of 
product development (including product development that precedes the 
establishment of an INAD file or the submission of a NADA).
    Finally, Sec.  558.5(i) of our regulations (21 CFR 558.5(i)) 
describes the procedure for requesting a waiver of the labeling 
requirements of Sec.  558.5(h) in the event that there is evidence to 
indicate that it is unlikely a new animal drug would be used in the 
manufacture of a liquid medicated feed.
    The reporting associated with NADAs and related submissions is 
necessary to ensure that new animal drugs are in compliance with 
section 512(b)(1) of the FD&C Act. We use the information collected to 
review the data, labeling, and manufacturing controls and procedures to 
evaluate the safety and effectiveness of the proposed new animal drug.
    Description of Respondents: Respondents include persons developing, 
manufacturing, and/or researching new animal drugs.
    In the Federal Register of February 15, 2019 (84 FR 4479), 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:

                                 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
----------------------------------------------------------------------------------------------------------------
514.1 & 514.6; applications and              182            0.05               9             212           1,908
 amended applications...........
514.1(b)(8) and 514.8(c)(1) \2\;             182            0.10              18              90           1,620
 evidence to establish safety
 and effectiveness..............
514.5(b), (d), (f); requesting               182            0.49              89              50           4,450
 presubmission conferences......
514.8(b); manufacturing changes              182            1.40             255              35           8,925
 to an approved application.....
514.8(c)(1); labeling and other              182            0.05               9              71             639
 changes to an approved
 application....................
514.8(c)(2) & (3); labeling and              182            0.43              78              20           1,560
 other changes to an approved
 application....................
514.11; submission of data,                  182            0.09              16               1              16
 studies and other information..
558.5(i); requirements for                   182            0.01               2               5              10
 liquid medicated feed..........
Form FDA 356V...................             182            2.92             531               5           2,655
Use of veterinary master files                15               1              15              20             300
 during all phases of product
 development (including product
 development that precedes the
 establishment of an INAD file
 or the submission of an NADA)..
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............           1,022  ..............          22,083
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing
  antimicrobial concerns as part of the overall pre-approval safety evaluation.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our previous 
estimates. However, as discussed, we have separately estimated the 
burden of the ``Use of veterinary master files during all phases of 
product development (including product development that precedes the 
establishment of an INAD file or the submission of an NADA)'' in table 
1, line 10. We base our estimate of the total annual responses for the 
use of veterinary master files on such uses initiated during calendar 
year 2018. We base our estimate of the hours per response upon our 
experience with the respondents' use of veterinary master files. We 
estimate that the time it takes to compile information and submit it to 
a veterinary master file will vary from 1 to 50 hours depending on the 
complexity of the information; therefore, we are estimating on average 
the burden per response to be 20 hours. Accordingly, our estimated 
burden for the information collection reflects an overall increase of 
124 hours and a corresponding increase of 14 responses.

    Dated: June 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13430 Filed 6-24-19; 8:45 am]
 BILLING CODE 4164-01-P