[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Pages 52063-52064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13643]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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 https://www.access.fda.gov. More information 
about the electronic blood establishment registration (eBER) system is 
available at: https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/blood-establishment-registration-and-product-listing. Online instructions are available at: https://www.fda.gov/media/116432/download?attachment. 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Number of
         21 CFR section; activity             Number of     responses per   Total annual            Average burden per response             Total hours
                                             respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                          --------------------------------------------------------------------------------------------------------------
    Total................................  ..............  ..............  ..............  .............................................           1,460
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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