2022-12928. Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request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 or Agency) is announcing the availability of a draft document entitled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry.” The draft guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA's Center for Biologics Evaluation and Research (CBER) designed to identify Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate. The voluntary use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for RMT products. The program is modeled after the formal standards and conformity assessment program (S-CAP) for medical devices.

DATES:

Submit either electronic or written comments on the draft guidance by September 14, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit either electronic or written comments on the collection of information by August 15, 2022.

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-2022-D-0745 for “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry.” 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 Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), 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 the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

Regarding the draft guidance: Tami Belouin, 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.

Regarding the proposed collection of information: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft document entitled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry.” The draft guidance describes a program at FDA's CBER for recognition of VCS relevant to RMT products regulated in CBER. The SRP-RMT is designed to identify and recognize VCS to facilitate the development and assessment of RMT products. The voluntary use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for RMT products. The program parallels the S-CAP for medical devices. CBER is issuing this draft guidance to obtain public comments on the program.

The draft guidance describes the purpose of the program, how the SRP-RMT is expected to facilitate RMT development, and describes how the Office of Tissues and Advanced Therapies in CBER generally intends to evaluate VCS for recognition in the SRP-RMT. This program will not apply to: (1) statutory and regulatory standards that are legally binding, such as certain provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq. ); (2) standards developed by Standards Development Organizations (SDOs) that do not follow consensus mechanisms; or (3) electronic data exchange standards for submissions to CBER.

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 “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” 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 (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 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.

Request for Recognition of a Voluntary Consensus Standard

OMB Control Number 0910-0338—Revision

Description: The draft guidance for industry entitled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies” provides guidance to industry about a program at CBER for recognition of VCS relevant to RMT products regulated in CBER. The voluntary use of recognized standards can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for RMT products.

The draft guidance describes the procedures CBER follows when a request for recognition of a VCS is received. The draft guidance also provides that any interested party may request recognition of a VCS. Section V of the draft guidance provides that a stakeholder can request recognition of a specific VCS by submitting an email request to SRP-RMT, and recommends that the request should, at a minimum, contain the following information:

• Name and electronic or mailing address of the requester;
• Name of the SDO;
• Title of the VCS;

• The VCS reference or SDO designation number and publication date ( e.g., Q1234-2019);

• Proposed list of products for which a standard could apply routinely;
• Rationale for request; and
• A brief description of the testing, performance, or other characteristics of the RMT products(s) or process(es) that would be addressed by the proposed standard.

We will use the requests to help identify for recognition appropriate VCS to facilitate the development and assessment of RMT products. The information is needed to support FDA's efforts to protect the public health and increase regulatory predictability for RMT products. We are requesting approval to revise the information collections included in OMB control number 0910-0338 to include the information collection associated with the draft guidance.

Description of Respondents: Respondents to this collection of information are product sponsors, applicants and other stakeholders interested in the development of RMT products regulated in CBER.

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

Table 1—Estimated Annual Reporting Burden  ¹

Activity/draft guidance section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Request for recognition of a voluntary consensus standard/Section V	9	1	9	3	27
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

In preparing our estimates of the annual number of respondents and the average burden per response, we reviewed estimates made by other FDA Centers regarding similar requests for recognition of standards, specifically the Center for Devices and Radiological Health (83 FR 46740 at 46742; September 14, 2018) and the Center for Drug Evaluation and Research (84 FR 4076 at 4078; February 14, 2019). We note that standards development is a lengthy process and the list of VCS that are potentially suitable for recognition by CBER is growing but not extensive. We determined that it would be reasonable to use an estimate of nine respondents, consistent with the estimates made by the other Centers. However, we increased our estimate of the amount of time it would take to prepare a request from 1 hour to 3 hours, given the amount of information that needs to be included in each VCS request. Still, because this is a new program, FDA is uncertain of the burden and seeks input on this estimate.

III. Electronic Access

Persons with access to the internet may obtain the draft guidance at either 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: June 9, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.