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.

Biologics License Applications (BLAs), Procedures and Requirements

OMB Control Number 0910-0338—Extension

This information collection helps support implementation of statutory and regulatory requirements under the Public Health Service Act (PHS) and the Federal Food, Drug, and Cosmetic Act (FD&C Act) that govern biologics product licensing. The Food and Drug Administration (FDA) has promulgated regulations in 21 CFR parts 600-680 setting forth applicable standards and procedures that include associated reporting, recordkeeping, and -disclosure requirements. Respondents to the information collection are persons or entities who engage in manufacture of biologics. Respondents to this collection of information are licensed manufacturers of biological products. Based on existing data, we estimate there are 371 such respondents. We provide relevant information and resources on our website at www.fda.gov/​vaccines-blood-biologics/​development-approval-process-cber/​biologics-license-applications-bla-process-cber regarding biologics license applications (BLAs).

Regulations in 21 CFR part 600, subparts A through C (21 CFR 600-600.21), and regulations in 21 CFR 601, subpart A (21 CFR 601.2-21 CFR 601.9) cover genera provisions and prescribe requisite content and format elements for applications. Regulations in 21 CFR part 601, subpart C (21 CFR 601.12-21 CFR 601.29) pertain to BLA changes; the electronic submission of information; the suspension, revocation, and reissuance of BLAs; and also provide for ( printed page 64655) the availability of guidance documents by FDA to assist respondents in complying with applicable requirements (21 CFR 601.29). Regulations in 21 CFR 601, subparts D and E, respectively, establish requirements applicable to diagnostic radiopharmaceuticals and for the accelerated approval of biological products for serious or life-threatening illnesses. Confidentiality of information submitted to FDA is covered in 21 CFR 601, subpart F (601.50-601.51). The regulations also provide for the approval of biological products when human efficacy studies are not ethical or feasible, as established in 21 CFR 601, subpart H. Finally, regulations in 21 CFR parts 610-680 establish both general and specific standards applicable to all biological products, including FDA requests for and protocols as required under 21 CFR 610.2, 660.6, 660.36, and 660.46 (previously approved under OMB control no. 0910-0206), as well as labeling provisions pertaining to exceptions or alternatives to the labeling of products in the Strategic National Stockpile (SNS) established in 21 CFR 610.28 (previously approved under OMB control no. 0910-0616).

To assist respondents with individual information collection elements, we have developed the following instruments, noting that FDA forms may be approved for use in other information collections:

Forms

Form FDA 356h, Application to Market a New or Abbreviated New Drug or Biologic for Human Use, provides a uniform format for submitting BLAs. Form FDA 356h is a fillable PDF form that may be submitted through our Electronic Submission Gateway (ESG), for which respondents must create and maintain a user account. Utilizing Form FDA 356h helps to ensure that an application is complete and contains all the necessary information, so that delays due to lack of information may be avoided. In addition, the form provides key information to FDA for efficient handling and distribution to the appropriate staff for review.

Form FDA 2252, Transmittal of Annual Report for Drugs and Biologics for Human Use, is used by an applicant of a licensed biological product to submit annual reports required by § 601.70(b) (21 CFR 601.70(b)). Form FDA 2252 is also a fillable PDF form.

Form FDA 2253, Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use, was developed for use by respondents to transmit specimens of advertisements and promotional labeling ( e.g., circulars, package labels, container labels, etc.), as well as labeling changes. The submission of this information is required by § 601.12 (21 CFR 601.12) for biological products and by 21 CFR 314.81 for drug products. Form FDA 2253 is a fillable PDF form

Form FDA 3674, Certificate of Compliance Under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank, was developed for use by respondents to certify submissions as required by section 402(j)(5)(B) of the Public Health Service (PHS) Act and is submitted through our ESG.

Cover Sheets

As provided for under 21 CFR part 601.2(a), FDA utilizes cover sheets, so denoted for purposes of identifying specific content information within a given application. For more information regarding BLA cover sheets, please refer to www.fda.gov/​vaccines-blood-biologics/​development-approval-process-cber/​regulatory-submissions-electronic-format-cber-regulated-products.

Guidance Documents

Agency regulations in 21 CFR 601.29 complement our Good Guidance Practice regulations in 21 CFR 10.115 by providing for the issuance of guidance documents to assist respondents with applicable requirements in 21 CFR part 601. We have issued the following guidance documents to assist respondents with activities covered by the information collection:

• The guidance document “Cooperative Manufacturing Arrangements for Licensed Biologics, ” (November 2008), available at www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​cooperative-manufacturing-arrangements-licensed-biologics, discusses strategies for meeting an increased need for flexible manufacturing arrangements. Since cooperative manufacturing arrangements can take a considerable amount of time to develop, the guidance is intended to be useful for planning purposes in the early phases of product development. Many companies that perform only limited aspects of manufacturing processes are interested in sharing or contracting parts of manufacturing in order to facilitate product development and manufacturing flexibility. The guidance document discusses recommended communication between licensed manufacturers and contract manufacturers regarding changes to production and facilities, results of tests and investigations regarding the product, types of products manufactured in the contract facility, and standard operating procedures. We believe that the information collection provisions in the guidance do not create a new burden for respondents but incorporate reporting and recordkeeping provisions that are part of usual and customary business practices.
• The guidance document entitled, “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies” (October 2023), describes a standards recognition program for regenerative medicine therapies (SRP-RMT) designed to identify and recognize Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products when such standards are appropriate. The guidance document also explains that any interested party may request recognition of a VCS. The guidance document is available for download from our website atwww.fda.gov/​regulatory-information/​search-fda-guidance-documents/​voluntary-consensus-standards-recognition-program-regenerative-medicine-therapies.

In the Federal Register of July 6, 2026 (91 FR 41046), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

Following publication of the 60-day notice, the Agency identified a multiplication and rounding error in the burden calculations. The corrected estimates are reflected in this 30-day notice. This revision does not reflect a substantive or programmatic change to the information collection. Our estimated burden for the information collection reflects an overall increase of approximately 4,612 hours and a corresponding increase of 2,642 responses. We attribute this adjustment to an increase in the number of product deviations we received in FY 2024 from licensed manufacturers, unlicensed registered blood establishments and transfusion services under § 606.171. This is likely due to the issuance of the revised guidance document titled, “Biological Product Deviation Reporting for Blood and Plasma Establishments” (85 FR 14682; March 13, 2020), which provided blood and plasma establishments with revised recommendations related to BPD reporting.