Microsoft Word - 0910-0543 Emergency Review Request 9-16-26 CLEAN

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UNITED STATES FOOD & DRUG ADMINISTRATION
OMB Control No. 0910-0543: PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR
AND TISSUE-BASED PRODUCTS
Request for Emergency Processing to Reinstate OMB Approval for Collections of
Information:
The Food and Drug Administration (FDA or we) is requesting emergency processing under 5
CFR 1320.13 to reinstate its approval for information collection provisions supporting
implementation of regulatory requirements that govern certain human cells, tissues, and cellular
and tissue-based products (HCT/Ps) found in 21 CFR part 1271. Manufacturers of HCT/Ps
regulated solely under the authority of section 361 of the Public Health Service Act (the PHS
Act) (42 U.S.C. 264) are required to register and list HCT/Ps pursuant to part 1271 (21 CFR part
1271) whether or not the HCT/P enters into interstate commerce. Manufacturers of HCT/Ps
regulated as drugs, devices and/or biological products under section 351 of the PHS Act (42
U.S.C. 262) and/or section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321),
are required to register and list HCT/Ps following the procedures in part 207 (21 CFR part 207)
(if a drug and/or biological product) or part 807 (21 CFR part 807) (if a device). Information
collection associated with the registration and listing requirements in parts 207 and 807 are
currently approved in OMB control numbers 0910-0045 and 0910-0625, respectively.
Although we have established internal procedures to ensure the timely renewal of our
information collections, Departmental reorganization and unexpected staff reductions and
departures over the past 18 months have caused a lag in publication of our Federal Register
notice required under 5 CFR 1320.8(d)(1). The document published in the September 9, 2026,
issue (91 FR 57347) under Docket ID FDA-2026-N-9638, but the delay prevented us from
submitting our ICR before its expiration on August 31, 2026. Our ability to impose penalties is a
critical mechanism in ensuring strict adherence to mandatory standards of safety and
effectiveness applicable to HCT/Ps. Products regulated under 21 CFR part 1271 are used in
implantation, transplantation, and infusion procedures and are subject to recordkeeping
requirements for documenting, among other things, procedures and controls to prevent the
introduction, transmission, or spread of communicable disease. Additionally, registration
requirements include established time schedules and content requirements. Similarly, the
regulations establish criteria for donor eligibility and mandate that screening and testing is
undertaken by a “responsible person.” Finally, the regulations compliment guidance documents
intended to clarify regulatory requirements in the context of scientific developments and FDA’s
current thinking on a topic to timely communicate relevant information on issues such as
considerations regarding emerging diseases and screening criteria. Any lapse in OMB approval
of the information collections established in 21 CFR part 1271 compromises our authority to
enforce the applicable requirements and necessarily undermines our ability to protect the public
health.
Because of the public health safety provisions found in the regulations, we believe expiration of
the ICR results in public harm, is the result of unanticipated consequences, and we are unable to
utilize normal clearance procedures to prevent the disruption of the collections of information.

At the same time, we believe a180-day approval would allow us the time necessary to consider
any public comment we receive in response to our 60-day notice on the information collection
elements and subsequently publish a 30-day notice announcing our submission of the ICR to
OMB and that we have requested emergency review.
signed by PHILLIP R.
PHILLIP R. KURS Digitally
KURS -S
Date: 2026.09.16 15:47:58 -04'00'
-S
__________________________________

Phillip Kurs
Acting Associate Director
for Policy
Center for Biologics Evaluation and Research (CBER)
Submitted: September 16, 2026