[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Notices]
[Pages 16270-16272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07764]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1517]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Abbreviated New Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 information collection provisions of 
abbreviated new animal drug applications.

DATES: Submit either electronic or written comments on the collection 
of information by June 17, 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 June 17, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 17, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
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-1517 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Abbreviated New Animal Drug 
Applications. '' 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

[[Page 16271]]

``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: 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: 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.

Abbreviated New Animal Drug Applications--Sections 512(b)(2) and (n)(1) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and 
(n)(1))

OMB Control Number 0910-0669--Extension

    Under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act), any person may file an abbreviated new animal drug 
application (ANADA) seeking approval of a generic copy of an approved 
new animal drug. The information required to be submitted as part of an 
ANADA is described in section 512(n)(1) of the FD&C Act. Among other 
things, an ANADA is required to contain information to show that the 
proposed generic drug is bioequivalent to, and has the same labeling 
as, the approved new animal drug. We allow applicants to submit a 
complete ANADA or to submit information in support of an ANADA for 
phased review. Applicants may submit Form FDA 356v with a complete 
ANADA or a phased- review submission to ensure efficient and accurate 
processing of information. We use the information submitted, among 
other things, to assess bioequivalence to the originally approved drug 
and thus, the safety and effectiveness of the generic new animal drug.
    We believe the demonstration of bioequivalence required by the 
statute does not need to be established on the basis of in vivo studies 
(blood level bioequivalence or clinical endpoint bioequivalence) for 
soluble powder oral dosage form products and certain Type A medicated 
articles. We are adding to this information collection applicant 
requests to waive the requirement to establish bioequivalence through 
in vivo studies (biowaiver requests) for soluble powder oral dosage 
form products or certain Type A medicated articles based upon either of 
two methods. We will consider granting a biowaiver request if it can be 
shown that the generic soluble powder oral dosage form product or Type 
A medicated article contains the same active and inactive ingredient(s) 
and is produced using the same manufacturing processes as the approved 
comparator product or article. Alternatively, we will consider granting 
a biowaiver request without direct comparison to the pioneer product's 
formulation and manufacturing process if it can be shown that the 
active pharmaceutical ingredient(s) (API) is the same as the pioneer 
product, is soluble, and that there are no ingredients in the 
formulation likely to cause adverse pharmacologic effects. We use the 
information submitted by applicants in the biowaiver request as the 
basis for our decision whether to grant the request.
    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. 
Veterinary master files are used by the animal pharmaceutical industry 
in support of information being submitted for new animal drug 
applications (NADAs), ANADAs, investigational new animal drug (INAD) 
files, and generic investigational new animal drug (JINAD) files. In 
previous information collection requests, we 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 recently combined the time necessary to compile and 
submit such information to veterinary master files within the burden 
estimates provided in the collection of information supporting new 
animal drug applications (OMB control number 0910-0032).
    The reporting associated with ANADAs and related submissions is 
necessary to ensure that new animal drugs are in compliance with 
section 512(b)(2) of the FD&C Act. As noted, we use the information 
submitted, among other things, to assess bioequivalence to the 
originally approved drug and thus, the safety and effectiveness of the 
generic new animal drug.
    Description of Respondents: The respondents for this collection of 
information are veterinary pharmaceutical manufacturers.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 16272]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of
                        Activity                           FDA Form No.      Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
ANADA...................................................            356v              18               1              18             159           2,862
Phased Review with Administrative ANADA.................            356v               3               5              15            31.8             477
Biowaiver request for soluble powder oral dosage form                N/A               1               1               1               5               5
 product, using same formulation/manufacturing process
 approach...............................................
Biowaiver request for soluble powder oral dosage form                N/A               5               5               5              10              50
 product, using same API/solubility approach............
Biowaiver request for Type A medicated article, using                N/A               2               2               2               5              10
 same formulation/manufacturing process approach........
Biowaiver request for Type A medicated article, using                N/A              10              10              10              20             200
 same API/solubility approach...........................
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............              51  ..............           3,604
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimates on our records of generic drug applications. 
We estimate that we will receive 21 ANADA submissions per year over the 
next 3 years and that three of those submissions will request phased 
review. We estimate that each applicant that uses the phased review 
process will have approximately five phased reviews per application. We 
estimate that an applicant will take approximately 159 hours to prepare 
either an ANADA or the estimated five ANADA phased review submissions 
and the administrative ANADA. Our estimates of the burden of biowaiver 
requests for generic soluble powder oral dosage form products and Type 
A medicated articles differ based on the type of product and the basis 
for the request, as shown in table 1. We estimate that an applicant 
will take between 5 and 20 hours to prepare a biowaiver request.
    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our previous 
estimate of the number of respondents submitting generic drug 
applications. However, as discussed, the burden for this information 
collection was increased by 265 hours and 18 responses since the last 
OMB approval. This is due to adding to this collection burden hours and 
responses for biowaiver requests.

    Dated: April 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07764 Filed 4-17-19; 8:45 am]
 BILLING CODE 4164-01-P