Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug and Veterinary Master Files, 106493-106496 [2024-31308]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human biologic product OMISIRGE (omidubicel-onlv). OMISIRGE is indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. Subsequent to this approval, the USPTO received a patent term restoration application for OMISIRGE (U.S. Patent No. 7,955,852) from Gamida Cell Ltd., and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated April 3, 2024, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of OMISIRGE represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. VerDate Sep<11>2014 23:58 Dec 27, 2024 Jkt 265001 II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for OMISIRGE is 4,563 days. Of this time, 4,242 days occurred during the testing phase of the regulatory review period, while 321 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: October 21, 2010. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on October 21, 2010. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): June 1, 2022. FDA has verified the applicant’s claim that the biologics license application (BLA) for OMISIRGE (BLA B125738) was initially submitted on June 1, 2022. 3. The date the application was approved: April 17, 2023. FDA has verified the applicant’s claim that BLA B125738 was approved on April 17, 2023. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,826 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 106493 No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: December 19, 2024. P. Ritu Nalubola, Associate Commissioner for Policy. [FR Doc. 2024–31262 Filed 12–27–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–5603] Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug and Veterinary Master Files AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) 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 collection of information associated with new animal drug applications and veterinary master files. DATES: Either electronic or written comments on the collection of information must be submitted by February 28, 2025. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 28, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the E:\FR\FM\30DEN1.SGM 30DEN1 106494 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 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– 2024–N–5603 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated with New Animal Drug and Veterinary Master Files.’’ 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, 240–402–7500. • 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 VerDate Sep<11>2014 23:58 Dec 27, 2024 Jkt 265001 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.govinfo.gov/content/pkg/FR-201509-18/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 ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. Under the PRA (44 U.S.C. 3501–3521), 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. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 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. New Animal Drug Applications and Veterinary Master Files—21 CFR 514 and 558, and Section 571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc) OMB Control Number 0910–0032— Extension This information collection supports implementation of section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b), which governs new animal drugs. Agency regulations in 21 CFR part 514 (part 514) and associated regulations 21 CFR part 558, establish format and content requirements regarding new animal drug application (NADA) submissions, as well as provide for pre-application submissions, amended applications, and application supplements. This information collection also supports implementation of section 571 of the FD&C Act (21 U.S.C. 360ccc) regarding application for conditional approval of new animal drug (CNADA) submissions. As set forth in the FD&C Act and regulations, requisite elements include safety and effectiveness data, proposed labeling, product manufacturing information, and where necessary, complete information on food safety (including microbial food safety) and any methods used to determine residues of drug chemicals in edible tissue from food producing animals. Applications must be prepared as appropriate to support the submission. Respondents to the information collection are persons developing, manufacturing, and/or researching new animal drugs. We developed Form FDA 356v (Application for Approval of a New Animal Drug (or Submission to Support New Animal Drug Approval)) to provide a uniform format for submitting requisite information and to ensure efficient processing by the Agency. E:\FR\FM\30DEN1.SGM 30DEN1 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices Form FDA 356v is available for download at https://www.fda.gov/aboutfda/reports-manuals-forms/forms. We also develop Agency guidance documents that may assist respondents with understanding NADA/CNADA requirements and related information collection activity. This includes FDA Guidance #152 (https://www.fda.gov/ regulatory-information/search-fdaguidance-documents/cvm-gfi-152evaluating-safety-antimicrobial-newanimal-drugs-regard-theirmicrobiological-effects), which outlines a risk assessment approach for evaluating the microbial food safety of antimicrobial new animal drugs and includes Agency recommendations in this regard. Under section 512(b)(3) of the FD&C Act, any person intending to file an NADA or supplemental NADA or a request for an investigational exemption under section 512(j) of the FD&C Act may request a conference prior to making a submission. Section 514.5 of our regulations (21 CFR 514.5) sets forth procedures for pre-submission conferences and describes documentation associated with making requests, and preparing for and conducting meetings. We encourage sponsors to submit data for review at the most appropriate and productive times in the drug development process. Rather than submitting all data for review as part of a complete application, we have found that the submission of data supporting discrete technical sections during the investigational phase is most appropriate and productive. This ‘‘phased review’’ of data submissions has created efficiencies for both us and the animal pharmaceutical industry. We also encourage, as appropriate, the submission of a Veterinary Master File (VMF). For more information on VMFs we invite you to visit https:// www.fda.gov/animal-veterinary/ development-approval-process/ veterinary-master-files. A VMF provides detailed information used in support of application submissions. Questions regarding VMF submissions may be directed to the Center for Veterinary Medicine at cvmesubmitter@ fda.hhs.gov. We have found that utilizing VMFs has increased the efficiency of the animal drug development and animal drug review processes for both FDA and the animal pharmaceutical industry, providing for the confidential exchange of information with FDA, and a process for reporting information outside of an NADA/CNADA or an Investigational New Animal Drug file, as well as an opportunity for increased communication with FDA during early stages of product development. A holder of a VMF may also authorize other parties to reference information included in the VMF without disclosing information in the file to those parties. 106495 Veterinary master files can be used as repositories for information that can be referenced in multiple submissions to the Agency. Section 558.5(i) of our regulations (21 CFR 558.5(i)) describes the procedure for requesting a waiver of the labeling requirements in § 558.5(h) if there is evidence to indicate that it is unlikely a new animal drug would be used in the manufacture of a liquid medicated feed. Finally, section 571 of the FD&C Act established requirements for the conditional approval of certain drugs 1 and the procedures for submitting CNADAs. Although FDA receives fewer than one application submission annually under section 571 of the FD&C Act when averaged over a 3-year period, we use a place holder of one response and 1 hour annually to account for burden associated with these submissions. The reporting associated with NADAs/CNADAs and related submissions is necessary to ensure that new animal drugs are in compliance with sections 512(b)(1) and 571 of the FD&C Act. We use the information collected to review the data, labeling, and manufacturing controls and procedures to evaluate the safety and effectiveness of the proposed new animal drug. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2 Number of respondents 21 CFR part, activity § 514; applications and amendments, pre-submission conference requests, evidence to establish safety and effectiveness, manufacturing, labeling, and other changes, submission of data studies and other changes. § 558.5(i); requirements for liquid medicated feed .............. Applications for conditional approval submitted under section 571 of the FD&C Act. Form FDA 356V ................................................................... Number of responses per respondent Total annual responses Average burden per response Total hours 254 2.8 711 42.25 ............. 30,040 254 3 .01 1 2.5 3 5 .................... 1 .................... 13 3 254 30.8 7,823 5,867 VMF submissions ................................................................. 16 1 16 0.75 (45 minutes). 20 .................. Total .............................................................................. ........................ ........................ 8,556 ........................ 36,243 320 1 There ddrumheller on DSK120RN23PROD with NOTICES1 are no capital costs or operating and maintenance costs associated with this collection of information. 2 Totals may not sum due to rounding. Although we have characterized the information collection activity as a reporting burden, we include in our estimate time required for searching data sources and preparing and maintaining necessary and applicable records. Based on the number of sponsors subject to animal drug user fees, we estimate that there are 254 respondents. We use this estimate to calculate the ‘‘number of responses per respondent’’ by dividing the total annual responses by the number of respondents except for CNADA submission and VMFs. For CNADAs we calculate an average of three responses and for VMF submissions we calculate and average of 16 VMFs. Our estimated burden for the information collection reflects an overall decrease of 2,606 hours and an increase of 928 responses. We attribute 1 Animal drugs intended for use in minor species, minor use in major species, or for serious or life- threatening conditions or unmet animal or human health needs where a demonstration of effectiveness would require a complex or particularly difficult study or studies. VerDate Sep<11>2014 23:58 Dec 27, 2024 Jkt 265001 PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1 106496 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices this adjustment to an increase in the number of submissions which generate a Form FDA 0356v; however, there is also a decrease to the submissions we received reported under part 514. Dated: December 16, 2024. P. Ritu Nalubola, Associate Commissioner for Policy. [FR Doc. 2024–31308 Filed 12–27–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2024–E–0299, FDA– 2024–E–0301, and FDA–2024–E–0302] Determination of Regulatory Review Period for Purposes of Patent Extension; VEOZAH AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VEOZAH and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. SUMMARY: Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by February 28, 2025. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by June 30, 2025. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. DATES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 28, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. ddrumheller on DSK120RN23PROD with NOTICES1 ADDRESSES: VerDate Sep<11>2014 23:58 Dec 27, 2024 Jkt 265001 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 Nos. FDA– 2024–E–0299, FDA–2024–E–0301, and FDA–2024–E–0302 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; VEOZAH.’’ 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, 240–402–7500. • 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 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 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 § 10.20 (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.govinfo.gov/content/pkg/FR-201509-18/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 ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106493-106496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31308]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-5603]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; New Animal Drug and Veterinary Master Files

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 collection of information 
associated with new animal drug applications and veterinary master 
files.

DATES: Either electronic or written comments on the collection of 
information must be submitted by February 28, 2025.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 28, 2025. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the

[[Page 106494]]

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-2024-N-5603 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Reporting Associated with New 
Animal Drug and Veterinary Master Files.'' 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, 240-
402-7500.
     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.govinfo.gov/content/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 ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.

New Animal Drug Applications and Veterinary Master Files--21 CFR 514 
and 558, and Section 571 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360ccc)

OMB Control Number 0910-0032--Extension

    This information collection supports implementation of section 512 
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
360b), which governs new animal drugs. Agency regulations in 21 CFR 
part 514 (part 514) and associated regulations 21 CFR part 558, 
establish format and content requirements regarding new animal drug 
application (NADA) submissions, as well as provide for pre-application 
submissions, amended applications, and application supplements. This 
information collection also supports implementation of section 571 of 
the FD&C Act (21 U.S.C. 360ccc) regarding application for conditional 
approval of new animal drug (CNADA) submissions. As set forth in the 
FD&C Act and regulations, requisite elements include safety and 
effectiveness data, proposed labeling, product manufacturing 
information, and where necessary, complete information on food safety 
(including microbial food safety) and any methods used to determine 
residues of drug chemicals in edible tissue from food producing 
animals. Applications must be prepared as appropriate to support the 
submission. Respondents to the information collection are persons 
developing, manufacturing, and/or researching new animal drugs.
    We developed Form FDA 356v (Application for Approval of a New 
Animal Drug (or Submission to Support New Animal Drug Approval)) to 
provide a uniform format for submitting requisite information and to 
ensure efficient processing by the Agency.

[[Page 106495]]

Form FDA 356v is available for download at https://www.fda.gov/about-fda/reports-manuals-forms/forms. We also develop Agency guidance 
documents that may assist respondents with understanding NADA/CNADA 
requirements and related information collection activity. This includes 
FDA Guidance #152 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-152-evaluating-safety-antimicrobial-new-animal-drugs-regard-their-microbiological-effects), which outlines a 
risk assessment approach for evaluating the microbial food safety of 
antimicrobial new animal drugs and includes Agency recommendations in 
this regard.
    Under section 512(b)(3) of the FD&C Act, any person intending to 
file an NADA or supplemental NADA or a request for an investigational 
exemption under section 512(j) of the FD&C Act may request a conference 
prior to making a submission. Section 514.5 of our regulations (21 CFR 
514.5) sets forth procedures for pre-submission conferences and 
describes documentation associated with making requests, and preparing 
for and conducting meetings. We encourage sponsors to submit data for 
review at the most appropriate and productive times in the drug 
development process. Rather than submitting all data for review as part 
of a complete application, we have found that the submission of data 
supporting discrete technical sections during the investigational phase 
is most appropriate and productive. This ``phased review'' of data 
submissions has created efficiencies for both us and the animal 
pharmaceutical industry.
    We also encourage, as appropriate, the submission of a Veterinary 
Master File (VMF). For more information on VMFs we invite you to visit 
https://www.fda.gov/animal-veterinary/development-approval-process/veterinary-master-files. A VMF provides detailed information used in 
support of application submissions. Questions regarding VMF submissions 
may be directed to the Center for Veterinary Medicine at 
[email protected]. We have found that utilizing VMFs has 
increased the efficiency of the animal drug development and animal drug 
review processes for both FDA and the animal pharmaceutical industry, 
providing for the confidential exchange of information with FDA, and a 
process for reporting information outside of an NADA/CNADA or an 
Investigational New Animal Drug file, as well as an opportunity for 
increased communication with FDA during early stages of product 
development. A holder of a VMF may also authorize other parties to 
reference information included in the VMF without disclosing 
information in the file to those parties. Veterinary master files can 
be used as repositories for information that can be referenced in 
multiple submissions to the Agency.
    Section 558.5(i) of our regulations (21 CFR 558.5(i)) describes the 
procedure for requesting a waiver of the labeling requirements in Sec.  
558.5(h) if there is evidence to indicate that it is unlikely a new 
animal drug would be used in the manufacture of a liquid medicated 
feed.
    Finally, section 571 of the FD&C Act established requirements for 
the conditional approval of certain drugs \1\ and the procedures for 
submitting CNADAs. Although FDA receives fewer than one application 
submission annually under section 571 of the FD&C Act when averaged 
over a 3-year period, we use a place holder of one response and 1 hour 
annually to account for burden associated with these submissions.
---------------------------------------------------------------------------

    \1\ Animal drugs intended for use in minor species, minor use in 
major species, or for serious or life-threatening conditions or 
unmet animal or human health needs where a demonstration of 
effectiveness would require a complex or particularly difficult 
study or studies.
---------------------------------------------------------------------------

    The reporting associated with NADAs/CNADAs and related submissions 
is necessary to ensure that new animal drugs are in compliance with 
sections 512(b)(1) and 571 of the FD&C Act. We use the information 
collected to review the data, labeling, and manufacturing controls and 
procedures to evaluate the safety and effectiveness of the proposed new 
animal drug.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Reporting Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
     21 CFR part, activity         Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Sec.   514; applications and               254             2.8             711  42.25...........          30,040
 amendments, pre-submission
 conference requests, evidence
 to establish safety and
 effectiveness, manufacturing,
 labeling, and other changes,
 submission of data studies
 and other changes.
Sec.   558.5(i); requirements              254             .01             2.5  5...............              13
 for liquid medicated feed.
Applications for conditional                 3               1               3  1...............               3
 approval submitted under
 section 571 of the FD&C Act.
Form FDA 356V.................             254            30.8           7,823  0.75 (45                   5,867
                                                                                 minutes).
VMF submissions...............              16               1              16  20..............             320
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............           8,556  ................          36,243
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Totals may not sum due to rounding.

    Although we have characterized the information collection activity 
as a reporting burden, we include in our estimate time required for 
searching data sources and preparing and maintaining necessary and 
applicable records. Based on the number of sponsors subject to animal 
drug user fees, we estimate that there are 254 respondents. We use this 
estimate to calculate the ``number of responses per respondent'' by 
dividing the total annual responses by the number of respondents except 
for CNADA submission and VMFs. For CNADAs we calculate an average of 
three responses and for VMF submissions we calculate and average of 16 
VMFs.
    Our estimated burden for the information collection reflects an 
overall decrease of 2,606 hours and an increase of 928 responses. We 
attribute

[[Page 106496]]

this adjustment to an increase in the number of submissions which 
generate a Form FDA 0356v; however, there is also a decrease to the 
submissions we received reported under part 514.

    Dated: December 16, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31308 Filed 12-27-24; 8:45 am]
BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.