Notice2026-20768
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications, Procedures and Requirements
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 9, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 91 Issue 195 (Friday, October 9, 2026)</title>
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[Federal Register Volume 91, Number 195 (Friday, October 9, 2026)]
[Notices]
[Pages 64654-64656]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20768]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-6667]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Biologics License
Applications, Procedures and Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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.
DATES: Submit written comments (including recommendations) on the
collection of information by November 9, 2026.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 0910-0338. 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, 240-402-5733,
<a href="/cdn-cgi/l/email-protection#a6f6f4e7f5d2c7c0c0e6c0c2c788ceced588c1c9d0"><span class="__cf_email__" data-cfemail="7f2f2d3e2c0b1e19193f191b1e5117170c51181009">[email protected]</span></a>.
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 <a href="https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber">https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber</a> 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
[[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 Sec. 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 Sec. 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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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 <a href="https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/regulatory-submissions-electronic-format-cber-regulated-products">https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/regulatory-submissions-electronic-format-cber-regulated-products</a>.
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:
<bullet> The guidance document ``Cooperative Manufacturing
Arrangements for Licensed Biologics,'' (November 2008), available at
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cooperative-manufacturing-arrangements-licensed-biologics">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cooperative-manufacturing-arrangements-licensed-biologics</a>,
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.
<bullet> 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
at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/voluntary-consensus-standards-recognition-program-regenerative-medicine-therapies">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/voluntary-consensus-standards-recognition-program-regenerative-medicine-therapies</a>.
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:
Estimated Annual Reporting Burden \1\
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Number of
21 CFR section FDA form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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600.14 Reporting of product deviations by licensed 3486 70 7.186 503 2.0 1,006
manufacturers..........................................
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606.171 Reporting of product deviations by licensed 3486 2,455 6.630 16,277 2.0 32,554
manufacturers, unlicensed registered blood
establishments and transfusion services................
1271.350(b) Reporting requirements (human cells tissues 3486 86 2.465 212 2.0 424
and cellular and tissue-based products)................
1271.350(b) CBER addendum report........................ \2\ 3486A 127 6.50 826 0.25 207
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Total............................................... .............. .............. .............. 17,818 .............. 34,191
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Five percent of the number of respondents ((2,455 + 86) x 0.05 = 127).
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 Sec. 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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20768 Filed 10-8-26; 8:45 am]
BILLING CODE 4164-01-P
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