[Federal Register Volume 87, Number 183 (Thursday, September 22, 2022)]
[Notices]
[Pages 57905-57907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20521]


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

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.

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

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: Submit written comments (including recommendations) on the 
collection of information by October 24, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or

[[Page 57906]]

by using the search function. The OMB control number for this 
information collection is 0910-0669. Also include the FDA docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[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.

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. Form FDA 356v is approved under OMB control 
number 0910-0032. 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.
    The information collection also includes 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 use the information submitted by applicants in the 
biowaiver request as the basis for our decision whether to grant the 
request. Therefore, the information collection references the guidance 
document GFI #171 ``Demonstrating Bioequivalence for Soluble Powder 
Oral Dosage Form Products and Type A Medicated Articles Containing 
Active Pharmaceutical Ingredients Considered to Be Soluble in Aqueous 
Media'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-171-demonstrating-bioequivalence-soluble-powder-oral-dosage-form-products-and-type-medicated) (May 2021), which 
discusses statutory bioequivalence requirements as well as 
qualifications for requesting a waiver from the requirements. The 
guidance document was developed consistent with the Agency's Good 
Guidance Practice regulations in 21 CFR 10.115, which provide for 
comment at any time.
    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. 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 March 18, 2022 (87 FR 15436), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received and considered one comment 
requesting the posting of new animal drug applications for public 
access. While FDA posts a summary of the safety and effectiveness data 
and information submitted in the application, which supports the basis 
for FDA's approval (https://www.fda.gov/animal-veterinary/approved-animal-drug-products-green-book/freedom-information-foi-summaries-approved-animal-drugs), we are prohibited from disclosing commercial 
confidential information contained in an ANADA.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                Number of                        Average
                          Activity                            FDA form No.      Number of     responses per   Total annual     burden per    Total hours
                                                                               respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
ANADA......................................................            356v              20               1              20             159        3,180
Phased review with administrative ANADA....................            356v               6               5              30            31.8          954
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 same              N/A               2               1               2               5           10
 formulation/manufacturing process approach................
Biowaiver request for Type A medicated article, using same              N/A               5               1               5              20          100
 API/solubility approach...................................
                                                                            ----------------------------------------------------------------------------
    Total..................................................  ..............  ..............  ..............              63  ..............        4,299
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 animal drug 
applications. We estimate that we will receive 26 ANADA submissions per 
year over the next 3 years and that 6 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.

[[Page 57907]]

    Our estimated burden for the information collection reflects an 
overall increase of 695 hours and a corresponding increase of 12 
responses. Based on a review of the information collection since our 
last request for OMB renewal, the increase in the burden hours estimate 
is attributable to an increase in the number of respondents submitting 
generic drug applications.

    Dated: September 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20521 Filed 9-21-22; 8:45 am]
BILLING CODE 4164-01-P