Notice2022-20521
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Abbreviated New Animal Drug Applications
Primary source
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Published
September 22, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 183 (Thursday, September 22, 2022)</title>
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[Federal Register Volume 87, Number 183 (Thursday, September 22, 2022)]
[Notices]
[Pages 57905-57907]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20521]
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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: 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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#045456455770656262446260652a6c6c772a636b72"><span class="__cf_email__" data-cfemail="a5f5f7e4f6d1c4c3c3e5c3c1c48bcdcdd68bc2cad3">[email protected]</span></a>.
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'' (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-171-demonstrating-bioequivalence-soluble-powder-oral-dosage-form-products-and-type-medicated">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-171-demonstrating-bioequivalence-soluble-powder-oral-dosage-form-products-and-type-medicated</a>) (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 (<a href="https://www.fda.gov/animal-veterinary/approved-animal-drug-products-green-book/freedom-information-foi-summaries-approved-animal-drugs">https://www.fda.gov/animal-veterinary/approved-animal-drug-products-green-book/freedom-information-foi-summaries-approved-animal-drugs</a>), 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\
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Number of Average
Activity FDA form No. Number of responses per Total annual burden per Total hours
respondents respondent responses response
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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...................................
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Total.................................................. .............. .............. .............. 63 .............. 4,299
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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 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
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