2023-27309. Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled “Advanced Manufacturing Technologies Designation Program.” FDA encourages the early adoption of advanced manufacturing technologies (AMTs) that have the potential to benefit patients by improving manufacturing and supply dependability and optimizing development time of drug and biological products. These technologies can be integral to ensuring quality and supporting a robust supply of drugs that are life-supporting, life-sustaining, of critical importance to providing healthcare, or in shortage. AMTs can directly improve product quality through higher capability manufacturing designs and enhanced controls ( e.g., leading to fewer human errors). This draft guidance provides recommendations to persons and organizations interested in participating in FDA's Advanced Manufacturing Technologies Designation Program, which is intended to facilitate the development of drugs, including biological products, manufactured using an AMT that has been designated as such under the program.

DATES:

Submit either electronic or written comments on the draft guidance by February 12, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit electronic or written comments on the proposed collection of information in the draft guidance by February 12, 2024.

ADDRESSES:

You may submit comments on any guidance at any time as follows:

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 No. FDA–2023–D–4974 for “Advanced Manufacturing Technologies Designation Program.” Received comments 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.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993–0002; or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

With regard to the draft guidance: Ranjani Prabhakara, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 6648, Silver Spring, MD 20993, 240–402–4652; or Anne Taylor, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911.

With regard to the proposed collection of information: 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, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Advanced Manufacturing Technologies Designation Program.” On December 29, 2022, the Food and Drug Omnibus Reform Act of 2022 (FDORA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 506L (21 U.S.C. 356l), which requires the establishment of an Advanced Manufacturing Technologies Designation Program and the publication of a related guidance. FDA's Advanced Manufacturing Technologies Designation Program offers a framework for persons or organizations ( e.g., applicants, contract manufacturers, technology developers) to request designation of a method or combination of methods of manufacturing a drug as an AMT. The program is intended to facilitate the development of drugs that are manufactured using a designated AMT, submitted in an application under section 505 of the FD&C Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262), and regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). FDA will expedite development and assessment of an application, including supplements, for drugs that are manufactured using a designated AMT as described in section 506L(d)(1) of the FD&C Act.

The development of this guidance takes into consideration feedback provided at a public meeting (see section 506L(e) of the FD&C Act) and comments submitted to the public docket (Docket No. FDA–2023–N–1259) about the public meeting. The meeting was held on June 8, 2023 (April 24, 2023, 88 FR 24807), to discuss the use of innovative manufacturing technologies for CDER- and CBER-regulated products and to solicit industry and public feedback regarding the Advanced Manufacturing Technologies Designation Program.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Advanced Manufacturing Technologies Designation Program.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (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 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.

Advanced Manufacturing Technologies Designation Program

OMB Control Number 0910–0139—Revision

This information collection supports implementation of requirements under section 506L of the FD&C Act. The Advanced Manufacturing Technologies Designation Program encourages early adoption of new technological advances in manufacturing processes by the pharmaceutical industry or other drug/biologic developers to ensure that regulatory assessments and new drug and biologic development are based on state-of-the-art pharmaceutical science. Any request for AMT designation will be reviewed by a team of FDA experts in quality assessment to evaluate the data and information submitted and to determine if the method of manufacturing or combination of methods meets the criteria of an AMT in section 506L of the FD&C Act. If 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.

We are issuing a draft guidance for industry entitled “Advanced Manufacturing Technologies Designation Program,” which outlines the process for submitting an AMT designation request; when and how FDA will communicate receipt of and provide advice on AMT designation requests; when and how FDA will assess AMT designation requests; the process by which FDA will engage with designated AMT holders and applicants for drugs manufactured using, referencing, or relying upon a designated AMT; and benefits related to drug development and application assessment.

We estimate the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden ¹

Section 506L of the FD&C Act	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
AMT designation request; Guidance for industry section III.B	20	1	20	10	200
Total			20		200
1  There are no capital or operating and maintenance costs associated with the information collection.

This draft guidance also refers to previously approved FDA collections of information. The collections of information in 21 CFR part 312 regarding product development including chemistry, proposed manufacturing procedures and controls, and requests for meetings have been approved under OMB control number 0910–0014. The collections of information in 21 CFR part 314 regarding applicable manufacturing information for NDAs are approved under OMB control number 0910–0001; and the collections of information in 21 CFR part 601 regarding applicable manufacturing information for BLAs are approved under OMB control number 0910–0338.

III. Electronic Access

Persons with access to the internet may obtain an electronic version of the draft guidance at https://www.fda.gov/​drugs/​guidance-compliance-regulatory-information/​guidances-drugs,https://www.fda.gov/​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics/​biologics-guidances, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents, or https://www.regulations.gov.

Dated: December 8, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.