2022-20521. 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 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, [e-mail].

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

Activity	FDA form No.	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
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 product, using same formulation/manufacturing process approach	N/A	1	1	1	5	5
Biowaiver request for soluble powder oral dosage form product, using same API/solubility approach	N/A	5	1	5	10	50
Biowaiver request for Type A medicated article, using same formulation/manufacturing process approach	N/A	2	1	2	5	10
Biowaiver request for Type A medicated article, using same API/solubility approach	N/A	5	1	5	20	100
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.

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.