[Federal Register Volume 84, Number 171 (Wednesday, September 4, 2019)]
[Notices]
[Pages 46543-46544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19078]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. FDA-2019-N-1517]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 October 
4, 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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0669. 
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, 
PRAStaff@fda.hhs.gov.

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.

Abbreviated New Animal Drug Applications--Section 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.
    In the Federal Register of April 18, 2019 (84 FR 16270), 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 46544]]



                                                      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
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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               1               5              10              50
 product, using same API/solubility approach............
Biowaiver request for Type A medicated article, using                N/A               2               1               2               5              10
 same formulation/manufacturing process approach........
Biowaiver request for Type A medicated article, using                N/A              10               1              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 3 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: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19078 Filed 9-3-19; 8:45 am]
 BILLING CODE 4164-01-P


