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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2023-D-4974]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 (PRA).
 DATES: Submit written comments (including recommendations) on the collection of information by January 17, 2025.
 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 0910-0139. Also include the FDA docket number found in brackets in the heading of this document.
 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: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Advanced Manufacturing Technologies Designation Program OMB Control Number 0910-0139—Revision This information collection supports the establishment of an FDA Advanced Manufacturing Technologies (AMT) Designation Program, as provided for in section 506L of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356l). Intending to enhance the development of and combat the shortage of critical medical products, the AMT Designation Program encourages early adoption of new technological advances in manufacturing processes by the pharmaceutical industry or other drug/
                    ( print page 102912)
                    biologic developers. FDA regulations in 21 CFR parts 210 and 211 govern current good manufacturing practice in the manufacturing, processing, packing, or holding of drugs and finished pharmaceuticals (including medical gases and active pharmaceutical ingredients), respectively. Applicable information collection and attendant burden are currently discussed, accounted for, and approved in OMB control number 0910-0139. We are revising the information collection to include the AMT Designation Program within the scope of activity, as authorized by section 506L of the FD&C Act, and account for attendant burden. Requests for AMT designation are reviewed by FDA to evaluate whether the data and information submitted meets the criteria established in section 506L of the FD&C Act. If a request for AMT designation is granted, then future new drug application (NDA), abbreviated new drug application (ANDA), or biologics license application (BLA) applicants may use or reference the designated AMT, noting specific application of the designated AMT to specific product development and inclusion in NDA, ANDA, or BLA submissions describing development and manufacturing processes. Also required by section 506L of the FD&C Act, we engaged with our stakeholders in a public meeting on June 8, 2023 (April 24, 2023, 88 FR 24807), to discuss innovative manufacturing technologies for drug and biological products and included a discussion of the AMT Designation Program. For more information regarding AMT, we invite readers to visit our website at 
                    *https://www.fda.gov/​emergency-preparedness-and-response/​mcm-issues/​advanced-manufacturing,*
                     which includes regular updates on Agency implementation of its AMT Designation Program. Finally, section 506L of the FD&C Act also provides for the issuance of guidance. In the 
                    **Federal Register**
                     of December 13, 2023 (88 FR 86333), we issued the draft guidance document entitled “Advanced Manufacturing Technologies Designation Program,” to communicate the goals, scope, and framework of the new program. We invited public comment under both our good guidance practices regulation in 21 CFR 10.115, and applicable PRA regulations in 5 CFR part 1320 and received a few comments. The comments included some requests for procedural clarification but focused mostly on requests for clarification of technical specifications and technologies that might qualify for AMT designation. Although we have updated the guidance document to address a number of public comments, we continue to implement the program and refine Agency processes. FDA estimates the burden of the information collection as follows: Table 1—Estimated Annual Reporting Burden1
Section 506L(c) FD&C Act
Number of
                             respondents
Number of
                             responses per respondents
Total annual
                             responses
Average
                             burden per 
                             response
Total
                             hoursSubmitting AMT designation requests; FDA Guidance for Industry, section III.B
20
1
20
10
2001
                         There are no capital or operating and maintenance costs associated with the information collection.
 Based on our experience with similar information collection activities that involve requests for FDA determinations, along with related preliminary and followup communications, we assume 10 hours is needed to complete the activities provided for in section 506L of the FD&C Act and discussed in the referenced guidance document. Although we have received fewer than 10 requests for AMT designation thus far, we are hopeful that 20 respondents will submit requests for AMT designation under the program. Dated: December 11, 2024. P. Ritu Nalubola, Associate Commissioner for Policy.


[FR Doc. 2024-29954 Filed 12-17-24; 8:45 am] BILLING CODE 4164-01-P