[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Pages 4479-4482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02479]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (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 collection of information 
associated with new animal drug applications.

DATES: Submit either electronic or written comments on the collection 
of information by April 16, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 16, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service

[[Page 4480]]

acceptance receipt is on or before that date.

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 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2019-N-0482 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Reporting Associated with New 
Animal Drug Applications and Veterinary Master Files.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff 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 Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: 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.

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) 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 #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

[[Page 4481]]

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, 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.
    We estimate 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 and 514.6; applications                182            0.05               9             212           1,908
 and 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) and (3); labeling                182            0.43              78              20           1,560
 and 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

[[Page 4482]]

 
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 a 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 preapproval 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, row 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, we report an 
additional 300 burden hours and 15 total annual responses in row 10. We 
are also correcting several rounding errors that were made in our last 
request for OMB approval. Correcting these rounding errors reduces our 
previously reported total burden hours and total responses. Thus, our 
estimated burden for the information collection reflects a net overall 
increase of 124 hours and a corresponding increase of 14 responses.

    Dated: February 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02479 Filed 2-14-19; 8:45 am]
 BILLING CODE 4164-01-P