90 FR 83 pgs. 18665-18667 - Agency Information Collection Activities; Proposed Collection; Comment Request; Compounding Animal Drugs From Bulk Drug Substances
Type: NOTICEVolume: 90Number: 83Pages: 18665 - 18667
Pages: 18665, 18666, 18667Docket number: [Docket No. FDA-2025-N-0082]
FR document: [FR Doc. 2025-07578 Filed 4-30-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0082]
Agency Information Collection Activities; Proposed Collection; Comment Request; Compounding Animal Drugs From Bulk Drug Substances
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) 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 recordkeeping provisions set forth in Guidance for Industry, GFI #256-Compounding Animal Drugs from Bulk Substances.
DATES:
Either electronic or written comments on the collection of information must be submitted by June 30, 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 June 30, 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:
[top] • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments.
• 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-2025-N-0082 for "Agency Information Collection Activities; Proposed Collection; Comment Request; Compounding Animal Drugs from Bulk Drug Substances." 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:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.
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.
Compounding Animal Drugs From Bulk Substances
OMB Control Number 0910-0904-Extension
[top] This information collection helps support recommendations discussed in FDA guidance. Animal drugs compounded from bulk drug substances by pharmacists and veterinarians do not meet certain important requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). To be legally marketed in accordance with animal drug approval requirements of the FD&C Act, an approval, conditional approval, or listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species? 1 is required, and compounded drugs do not go through any of these pre-market review processes. (Information collection associated with new animal drug applications is approved under OMB control no. 0910-0032; information collection pertaining to index of legally marketed unapproved new animal drugs for minor species is approved under OMB control no. 0910-0605.) Further, all animal drugs are required to, among other things, be made in accordance with current good manufacturing practice (CGMP) requirements and have adequate directions for use, requirements not met by compounded drugs. 2 Thus, drugs compounded from bulk drug substances violate the FD&C Act because they are not approved or indexed, are not made according to CGMP, and cannot satisfy the FD&C Act's adequate directions for use provision (which requires, among other things, that a prescription drug have FDA-approved labeling). However, FDA has generally refrained from taking enforcement action against animal drugs
Footnotes:
1 ?Sections 512, 571, and 572 of the FD&C Act (21 U.S.C. 360b, 360ccc, 360ccc-1).
2 ?Section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), 21 CFR parts 210 and 211, and section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)).
To assist respondents in understanding FDA's current thinking about animal drug compounding from bulk substances, our Center for Veterinary Medicine developed GFI #256 entitled " Compounding Animal Drugs from Bulk Drug Substances " ( https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances ). The guidance describes circumstances under which FDA generally does not intend to take enforcement action against pharmacists and veterinarians who compound animal drugs from bulk drug substances.
FDA estimates the burden of this collection of information as follows:
| Activity | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response (1 minute) | Total hours |
|---|---|---|---|---|---|
| Documenting rationales by licensed veterinarian/pharmacist compounders in state-licensed pharmacies or Federal facilities | 7,500 | 1,134 | 8,505,000 | 0.017 | 144,585 |
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
We base our estimates on our experience with the regulation of compounded animal drugs. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07578 Filed 4-30-25; 8:45 am]
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