Notice2024-13643
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
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
June 21, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) 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 89 Issue 120 (Friday, June 21, 2024)</title>
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[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Pages 52063-52064]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13643]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0783]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Establishment
Registration and Product Listing for Manufacturers of Human Blood and
Blood Products and Licensed Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) 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
[[Page 52064]]
collection of information by July 22, 2024.
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 0910-0052. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#46161407153227202006202227682e2e3568212930"><span class="__cf_email__" data-cfemail="89d9dbc8dafde8efefc9efede8a7e1e1faa7eee6ff">[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.
Establishment Registration and Product Listing for Manufacturers of
Human Blood and Blood Products and Licensed Devices
OMB Control Number 0910-0052--Extension
This information collection helps support implementation of section
510 of the Federal Food Drug and Cosmetic Act (21 U.S.C. 360), as well
as related Agency regulations in part 607 (21 CFR part 607) and forms.
All owners or operators of establishments that manufacture human blood
and blood products are required to register with FDA, unless they are
exempt under Sec. 607.65. A list of every blood product manufactured,
prepared, or processed for commercial distribution must also be
submitted, among other information. Establishments must register within
5 days after beginning operations or submission of a biologics license
application and register annually between October 1 and December 31.
The regulations set forth procedures and requirements pertaining to
establishment registration and product listing for manufactures of
human blood and blood products and licensed devices, including initial
registration and product listing, annual registration, product listing
updates and waiver requests. Owners or operators of certain
establishments that engage in the manufacture of blood products must
register and submit a list of every blood product in commercial
distribution (Sec. 607.20(a)). Initial and subsequent registrations
and product listings must be submitted electronically through FDA's
Center for Biologics Evaluation and Research (CBER) Blood Establishment
Registration and Product Listing system through the FDA Industry
Systems page available at <a href="https://www.access.fda.gov">https://www.access.fda.gov</a>. More information
about the electronic blood establishment registration (eBER) system is
available at: <a href="https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/blood-establishment-registration-and-product-listing">https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/blood-establishment-registration-and-product-listing</a>. Online instructions are available at: <a href="https://www.fda.gov/media/116432/download?attachment">https://www.fda.gov/media/116432/download?attachment</a>. The Form FDA 2830
previously associated with this information collection is no longer in
use.
FDA may grant a request for waiver of this requirement prior to the
date on which the information is due (Sec. 607.22(a)). Waiver requests
must be submitted in writing and must include, among other information,
the specific reasons why electronic registration is not reasonable for
the registrant.
Establishment registration and product listing information assists
FDA in its inspections of facilities, among other uses, and its
collection is essential to the overall regulatory scheme designed to
ensure the safety of the Nation's blood supply.
Description of Respondents: Respondents to this collection of
information are human blood and plasma donor centers, blood banks,
certain transfusion services, other blood product manufacturers,
independent laboratories that engage in quality control and testing for
registered blood product establishments and manufacturers of devices
licensed under section 351 of the Public Health Service Act.
In the Federal Register of March 12, 2024 (89 FR 17856), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section; activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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607.20(a), 607.21, 607.22, 607.25, 176 1 176 1............................................ 176
607.40; Initial registration and
submission of product listing.
607.21, 607.22, 607.25, 607.26, 607.31, 2,545 1 2,545 0.5 (30 minutes)............................. 1,273
607.40; Annual registration.
607.21, 607.25, 607.30(a), 607.31, 42 1 42 0.25 (15 minutes)............................ 10
607.40; Product listing update.
607.22(b); Written waiver request........ 1 1 1 1............................................ 1
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Total................................ .............. .............. .............. ............................................. 1,460
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our evaluation of calendar year 2022 data from CBER's
Blood Establishment Registration and Product Listing system, we have
adjusted the currently approved burden estimate we attribute to
establishment registration and product listing to reflect a decrease in
product listing updates and an increase in the number of initial
registrations. Our estimated burden for the information collection
reflects an overall decrease of 36 hours.
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13643 Filed 6-20-24; 8:45 am]
BILLING CODE 4164-01-P
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